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Japan Regional Implementation Guide
DRAFT
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ICH M8 Expert Working Group
JP Test team
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目次 Table of Contents
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1.
目的: Purpose ............................................................................................................. 6
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2.
用語の定義: Terms and Definitions ............................................................................. 6
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3.
適用範囲: Scope.......................................................................................................... 6
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4.
変更管理 Change Control ........................................................................................... 6
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5.
全般的事項: General ................................................................................................... 6
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5.1 eCTD 申請時に含めるべき構成物: Components of the eCTD submission.................. 6
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5.2 日本で申請する eCTD に含めてはならない構成物: Components NOT to be attached
for Japan eCTD Submission ....................................................................................... 8
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5.3 提出に関する事項: Points to Consider for submitting eCTD ....................................... 8
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5.3.1
提出方法: Submission Procedure......................................................................... 8
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5.3.2
受領確認: Acknowledgement ............................................................................... 8
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5.3.3
提出媒体: Media ................................................................................................... 8
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5.3.4
輸送: Transportation............................................................................................. 9
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5.4 動作要件: Operating Requirements ............................................................................. 9
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5.5 eCTD とする場合の要件
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6.
Requirements for eCTD Submission .............................. 10
eCTD に含まれるフォルダ構造及びファイルパスに関する要件: Requirements for
Folder Structure and File Path for Japan eCTD Submission..................................... 11
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6.1 基本フォルダ構造: Basic Folder Structure ................................................................ 11
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6.2 フォルダ命名規則: Folder Naming Convention ......................................................... 12
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6.3 最大パス長: Maximum Path Length .......................................................................... 12
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eCTD に含まれるファイル形式に関する要件: Requirements for File Formats for
Japan eCTD Submission .......................................................................................... 12
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eCTD に含まれる PDF ファイルに関する要件: Requirements for Japan eCTD
Submission Package - PDF ...................................................................................... 13
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8.1 PDF ファイル: PDF Files .......................................................................................... 13
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8.1.1
フォントの仕様: Fonts ....................................................................................... 13
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8.1.2
画像を含む PDF ファイル: PDF files containing images ................................... 14
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8.1.3
スキャン文書の解像度: Resolution of Scanned (Image) Document................... 15
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8.1.4
ファイルサイズ: File Size .................................................................................. 15
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8.1.5
ハイパーテキスト・リンク及びブックマーク: Hypertext Linking and Bookmarks15
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8.1.6
ページサイズ: Page Size ................................................................................... 16
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8.1.7
制限事項: Limitations and Restrictions ............................................................... 17
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8.1.8
過去に作成された資料の取扱い: Handling of Existing Documents which Created
in the Past .......................................................................................................... 17
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8.1.9
Excel ファイルの提出を求められた PDF 資料の取り扱い ................................. 18
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eCTD に含まれるインスタンスに関する要件: Requirements for Japan eCTD
Submission Package – eCTD XML Message Instance ............................................. 18
9.1 キャラクターエンコード: Character Encoding ......................................................... 18
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9.2 値を持たない要素及び属性の取り扱い
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9.3 日本固有の要素／属性の使用方法: eCTD Operation in Japan .................................. 18
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9.3.1
9.3.2
9.3.3
9.3.4
9.3.5
9.3.6
9.3.7
9.3.8
9.3.9
9.3.10
9.3.11
9.3.12
9.3.13
9.3.14
9.3.15
9.3.16
9.3.17
9.3.18
9.3.19
9.3.20
Element / Attribute without meaningful value18
applicant ............................................................................................................ 19
application .......................................................................................................... 20
applicationReference ......................................................................................... 22
categoryEvent .................................................................................................... 25
contextOfUse ..................................................................................................... 26
document ........................................................................................................... 27
documentReference........................................................................................... 30
ingredient ........................................................................................................... 30
keyword ............................................................................................................. 31
keywordDefinition............................................................................................... 32
manufacturedProduct......................................................................................... 32
previousKeywordDefinition ................................................................................ 34
priorityNumber.contextOfUse ............................................................................. 34
priorityNumber.document ................................................................................... 34
productCategory ................................................................................................ 34
relatedContextOfUse ......................................................................................... 35
review ................................................................................................................ 35
sequenceNumber.submission ............................................................................ 39
submission ......................................................................................................... 39
submissionUnit .................................................................................................. 41
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10.
日本の eCTD 申請において使用されるスキーマに関する要件: Requirements for
Japan eCTD Submission Package - XML Schema ................................................... 42
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11.
セキュリティ: Security.............................................................................................. 42
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12.
ライフサイクル管理: Life cycle Management ........................................................... 43
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12.1 概要: Lifecycle Overview ........................................................................................... 43
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12.2 eCTD 初回提出時に関する要件: Requirements for Japan eCTD Submission Sequence 000001 ..................................................................................................... 44
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12.2.1 初回提出時のフォルダ構造: Folder Structure .................................................... 44
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12.2.2 初回提出時のファイル: Document Files ............................................................ 44
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12.2.3 初回提出時のインスタンス:eCTD XML Message Instance ............................... 45
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12.2.4 特に複雑なケースの記載例: Instructions for Complex Cases ............................ 48
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12.3 eCTD 改訂時に関する要件: Requirements for Japan eCTD Submission – Sequence
000002 and Higher.................................................................................................... 48
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12.3.1 改訂時のフォルダ構造: Folder Structure ........................................................... 48
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12.3.2 改訂時のファイル: Document Files ................................................................... 49
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12.3.3 改訂時の XML メッセージインスタンス: XML Message Instance ..................... 50
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12.3.3.1 applicant ................................................................................................... 50
12.3.3.2 application ................................................................................................ 50
12.3.3.3 applicationReference ................................................................................ 50
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12.3.3.4
12.3.3.5
12.3.3.6
12.3.3.7
12.3.3.8
12.3.3.9
12.3.3.10
12.3.3.11
12.3.3.12
12.3.3.13
12.3.3.14
12.3.3.15
12.3.3.16
12.3.3.17
12.3.3.18
12.3.3.19
12.3.3.20
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categoryEvent ........................................................................................... 50
contextOfUse ............................................................................................ 51
document .................................................................................................. 51
documentReference ................................................................................. 51
ingredient .................................................................................................. 51
keyword .................................................................................................... 51
keywordDefinition ................................................................................... 52
manufacturedProduct ............................................................................. 52
previousKeywordDefinition ..................................................................... 52
priorityNumber.contextOfUse ................................................................. 52
priorityNumber.document ....................................................................... 52
productCategory ..................................................................................... 52
relatedContextOfUse .............................................................................. 52
review ..................................................................................................... 52
sequenceNumber.submission ................................................................ 53
submission.............................................................................................. 53
submissionUnit ....................................................................................... 53
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13.
コントロールド・ボキャブラリ: Controlled Vocabularies ........................................ 54
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14.
問い合わせ先: Contacts ............................................................................................ 54
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15.
参考文献 .................................................................................................................... 54
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16.
別添: Appendices ...................................................................................................... 55
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16.1 M1 の作成要領: Specification for Module 1 ............................................................... 55
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16.1.1 目的: Purpose .................................................................................................. 55
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16.1.2 フォルダ構成並びにフォルダ命名規則: Folder structure and naming
convention ......................................................................................................... 55
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16.1.3 第 1 部のファイル命名について: File name ....................................................... 55
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16.1.4 V3.2.2 との比較 : Mapping between eCTD v3.2.2 jp-regional-index.xml and
regional portions of eCTD v4.0 XML Message Instance .................................... 57
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16.2 XML サンプルインスタンス: Sample XML Massage Instance.................................. 64
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16.2.1.1
初回提出時 ............................................................................................... 64
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16.3 カバーレター様式: Form - Cover Letter .................................................................. 121
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16.4 日本向け eCTD v4.0 XML Message Instance の基本構造: Basic Structure of JP eCTD
v4.0 XML Message Instance ................................................................................... 121
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16.5 コントロールド・ボキャブラリ: Controlled Vocabularies ...................................... 126
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16.6 Validation Criteria .................................................................................................... 126
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Notice To Readers
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Sections of this document referencing the HL7 Version 3 Standard: Regulatory Product Submission
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Release 2 Draft Standard for Trial Use 2 are used with the publisher’s permission.
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are copyrighted by Health Level Seven International ® ALL RIGHTS RESERVED
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These sections
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1.
目的: Purpose
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本実装ガイドは ICH eCTD v4.0 ICH Implementation Guide を補完する文書である。本ガ
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イドは、日本での ICH eCTD v4.0 の実装における eCTD XML メッセージの作成に係る要
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件として、日本特有の情報（例：管理情報）の提供方法や、運用ルールを説明する。
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This Implementation guide is a supplemental document of the ICH eCTD v4.0
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Implementation Guide.
This guide provides instructions for creating an eCTD XML message
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for eCTD v4.0 implementation in Japan.
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provide Japan specific information (e.g., administrative information) in the message and describe
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business rules that should be applied to the message.
The instructions include, but not limited to, how to
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2.
用語の定義: Terms and Definitions
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本ガイドで用いられている用語の定義を以下の表に示す。
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Note:現時点では表に記載は無いが最終版までに入力される。
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The following table defines some common terms in this document.
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Note: Though terms and definitions are not described in the current version, these will be
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filled by the official release.
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Term
(Japanese)
Term
Definition (Japanese)
Definition
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3.
適用範囲: Scope
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本実装ガイドは、新医療用医薬品の製造販売承認申請書または承認事項一部変更承認
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申請書に添付すべき資料を電子的に提出する場合に適用される。なお、本版は、ICH Step
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2 for Testing 用（○年○月～○月実施予定）とし、テストの結果によって改訂される。
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The scope of this guide is specifically for the cases where the dossier attached to the
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application for marketing approval or for partial change of approved information for ethical
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drugs in Japan.
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2012 to XX, 2012.
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guide will be updated.
This version of this guide is for the ICH Step 2 for Testing slated from Jun,
As testing is conducted and the standard evolves, the information in this
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4.
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変更管理 Change Control
To be added.
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5.
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5.1
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全般的事項: General
eCTD 申請時に含めるべき構成物: Components of the eCTD submission
eCTD 申請時に含めるべき構成物を以下に示す。
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・ フォルダ
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・ eCTD v4.0 XML メッセージインスタンス
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・ ファイル*
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The eCTD submission is composed of the following:
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・ Folder
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・ eCTD v4.0 XML Message Instance
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・ Files*
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*ファイルには以下の種類がある。
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1) インスタンスから参照される ICH CTD 文書ファイル
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2) インスタンスから参照される日本特有の文書ファイル
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第一部文書
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「5.3.7 患者データ一覧表及び症例記録」
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3) インスタンスから参照されないファイル
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カバーレター
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ハッシュ値ファイル
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*: The files in eCTD submission are the following:
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1) ICH CTD Document Files referred from the eCTD XML Message Instance
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2) Japan Specific Document Files referred from the eCTD XML Message Instance
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Japan administration document files (Module 1 documents)
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Patient listings (Section 5.3.7)
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3) Document Files NOT Referred from the Message Instance
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Cover Letter
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sha256.txt
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日本で申請する eCTD に含めてはならない構成物: Components NOT to be attached
5.2
for Japan eCTD Submission
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日本で申請をする場合、以下の構成物は含めてはならない。
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1) 日本以外の地域の実装ガイドで規定されている固有情報ファイル
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2) 日本以外の地域の実装ガイドで規定されている要素及び属性、ならびにそれらの
値
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Following components are not accepted on Japan eCTD Submission:
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1) Files defined by other Regional Implementation Guide
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2) XML elements, attributes, and values given for those elements or attributes
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提出に関する事項: Points to Consider for submitting eCTD
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5.3
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5.3.1
提出方法: Submission Procedure
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申請者は承認申請手続きを行った後、eCTD 資料を医薬品医療機器総合機構に提出す
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ること。なお eCTD 受付番号は企業側の申請予定日 2 週間前より、番号取得のための申
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請を行い、eCTD 受付番号発番の手続きを行うこと。この手続きに関しては別途連絡す
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る。
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The applicant submits eCTD submission to PMDA after specified procedures for marketing
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approval application.
The applicant applies to PMDA for a eCTD Receipt Number 2 weeks
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prior to the Submission Date.
Detailed procedures will be informed.
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5.3.2
受領確認: Acknowledgement
医薬品医療機器総合機構は提出資料を確認し、受理可能であると判断された場合は、
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eCTD 用カバーレターの出力用紙に受領印を押印する。 申請者は、この受領印をもって
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受領確認がなされたものとする。
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PMDA confirms the eCTD submission and seals receipt stamp when it is acceptable.
The
receipt stamp acknowledges the receipt of the eCTD submission.
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5.3.3
提出媒体: Media
CD-R または DVD-R を提出媒体とする。その他の媒体によって提出せざるを得ない場
合には、提出先に事前に相談すること。
提出する電子媒体には、識別するための以下の内容を記載したラベルを貼付するか、
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又は直接記載する。なお、複数の申請を一つの eCTD で対応する場合は、代表する申請
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情報で良い。
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1.
eCTD 受付番号
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2.
申請区分
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3.
申請日
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4.
資料提出日
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5.
販売名
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6.
申請者名
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7.
提出電子媒体が複数となった場合、媒体の順序が識別できる番号（当該
枚数目／総枚数）
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8.
提出連続番号
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9.
備考
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CD-R or DVD-R is used as the submission media. Consult PMDA in advance if it is
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technically not possible to use those media.
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The following information should be provided on the label of the submitting media or directly
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on the media.
When the eCTD covers multiple applications, only the representative
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application’s information should be provided.
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1.
eCTD Receipt Number
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2.
Category of Application
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3.
Submission Date
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4.
Date of submitting this media
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5.
Brand Name
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6.
Applicant Name
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7.
Sequential number to identify the order of the medium when there are multiple
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media (order of this medium / total number of media)
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8.
Sequence Number
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9.
Remarks
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輸送: Transportation
5.3.4
審査当局が安全な電子的ゲートウェイを開発するまで、申請資料は医薬品医療機器総
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合機構に直接持ち込まれるか、あるいは郵送すること。
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Until the regulatory authorities can develop secure electronic gateways, submissions should
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continue to be manually brought to PMDA or physically transported by courier or registered
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mail.
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5.4
動作要件: Operating Requirements
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申請者は eCTD として申請する場合、審査当局が公表する審査の標準環境を考慮し、
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eCTD 通知で要求する機能（表示、リンク等）が動作することを保証しなければならな
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い。動作を確認した環境は eCTD 用カバーレター（様式 1）内に記載し、審査当局側に
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連絡すること。
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審査当局において、公表する審査の標準環境で上記動作が確認できない場合、あるい
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は不当な表示が認められた場合は申請者に差換えを求めることとし、その間のタイムク
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ロックを申請者側とする。申請者は eCTD 資料に表示上の問題が生じ、電子的に提出が
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できない場合は、事前に審査当局に相談し、紙への切り替え、取扱い、対応手順等を定
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め適宜対応すること。 なお、提出前に動作を確認する方法については、審査当局のホ
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ームページに掲載された情報を確認の上で適宜実施すること。
なお、閲覧時に必要となるプラグインソフトの使用は原則として認めないことする。
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ただし、作成用に使用するプラグインソフトはこの限りではない。
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Applicants should take into account the reviewers’ standard computer environment in which
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the applicants guarantee that the functions required by eCTD Notices (e.g., viewing, hypertext
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links, etc.) operate appropriately.
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should be reported to PMDA by the eCTD Cover Letter (Form 1).
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The environment where the applicant confirms the operation
When PMDA is not able to proper operation of these functions in the standard computer
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environment or finds inappropriate view, the applicant is asked for correction by using their own
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time clock. When the applicant finds that it is not possible to submit their submission in eCTD
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format due to any error in viewing the dossier, the applicant should consult PMDA in advance as
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to switching to paper submission, how to handle the submission, detailed procedures and such,
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and should act accordingly.
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website, and the applicant should conduct the operation check by themselves by referencing it.
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Plug-in software used for viewing eCTD documents will not be accepted as a general rule.
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The reviewers’ standard computer environment is on PMDA
Plug-in software used for creating does not need to be within the scope of this restriction.
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5.5
eCTD とする場合の要件
Requirements for eCTD Submission
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eCTD で申請する場合はすべての提出書類を電子的に提出しなければならない。ただ
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し、電子署名による受付が可能とされるまでの間、署名又は記名・捺印等のページは当
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該ページをスキャニングし、電子媒体に保存して eCTD に添付すること。その際、当該
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頁を間違いなくスキャニングしたことを示す陳述書を書面ならびに電子的に提出する
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こと。陳述書の電子ファイルは 第 1 部 3 項に含めること。
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In eCTD Submission, all the documents need to be provided in electronic format.
Until the
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digital signature becomes acceptable, the pages with signature, seal, or such should be scanned
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and stored in eCTD as electronic files.
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pages were scanned appropriately should be submitted in paper and in electronic format.
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letter should be stored in Module 1.3.
In such case, written letters with statement that the
The
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6.
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6.1
eCTD に含まれるフォルダ構造及びファイルパスに関する要件:
Requirements for Folder Structure and File Path for Japan eCTD
Submission
基本フォルダ構造: Basic Folder Structure
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基本フォルダ構造は、ICH IG 記載のフォルダ構造に基づき作成すること。ただし、第
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一階層フォルダ名は eCTD 受付番号とし、第二階層フォルダ名はシーケンス番号とする
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こと。また、m1 フォルダ配下に jp フォルダを作成し、Module 1 に係るファイルとカバ
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ーレターは、jp フォルダ直下に格納すること。原則として第 4 部、第 5 部を構成する個々
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の報告書フォルダを作成する場合は一報告書ごとにフォルダを作成すること。また、症
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例一覧表、非臨床報告書並びに臨床総括報告書は以下の通りフォルダを作成し、対応す
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ること。
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1)
用量設定の根拠となった主要な試験及び主要な有効性の検証試験の症例一
覧表
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2)
実施された全ての臨床試験において副作用が観察された症例の一覧表
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3)
実施された全ての臨床試験において重篤な有害事象が観察された症例の一
覧表
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4)
の一覧表
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5)
実施された全ての臨床試験において観察された臨床検査値の変動を適切に
示した図
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実施された全ての臨床試験において臨床検査値異常変動が観察された症例
The basic folder structure should be prepared by following the ICH IG.
The first level folder
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name should be the eCTD Receipt Number, and the second level folder name should be the
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sequence number.
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located in the m1/jp folder. See 16.1.2 for details of m1/jp folder.
346
should be created when creating folders for the reports in Module 4 and/or 5.
347
following folders should be created for the case report tabulation, non-clinical study reports, and
348
clinical study reports.
All files related to JP Module 1 along with the Cover Letter should be
A folder per study report
In addition, the
349
1)
Patient data listing in the pivotal studies for dose selection and efficacy confirmation.
350
2)
Patient data listings of the subjects with adverse reactions in all the clinical studies.
351
3)
Patient data listings of the subjects with serious adverse events in all the clinical
352
353
studies.
4)
354
355
Patient data listings of the subjects with abnormal laboratory values in all the clinical
studies included.
5)
The charts showing the changes of laboratory values in all the clinical studies.
356
357
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6.2
フォルダ命名規則: Folder Naming Convention
359
原則、ICH IG 記載のフォルダ命名規則に基づき作成すること。第 4 部、第 5 部に含ま
360
れる報告書ごとのフォルダは、試験番号等内容が判別できる名称とすること。また、第
361
5 部「5.3.7 患者データ一覧表及び症例記録」の文書を格納するフォルダは以下の通り作
362
成する。これらフォルダは「537-crf-ipl」フォルダ以下に作成する。
363
1)
5-3-7-patients-lists
364
2)
5-3-7-ae-lists
365
3)
5-3-7 sea-lists
366
4)
5-3-7-lab-lists
367
5)
5-3-7-lab-figs
368
369
Folders should be named in accordance with the naming convention defined in ICH IG.
The
370
folder for each study report in Module 4 or 5 should be named in the way by which the study is
371
identifiable (e.g., study ID).
372
5.3.7 Case Report Forms and Individual Patient Listings" in Module 5 should be as follows.
373
These folders should be located under the “537-crf-ipl” folder.
The name of the folders containing the documents for "Module
374
1)
5-3-7-patients-lists
375
2)
5-3-7-ae-lists
376
3)
5-3-7 sea-lists
377
4)
5-3-7-lab-lists
378
5)
5-3-7-lab-figs
379
380
6.3
最大パス長: Maximum Path Length
381
最大パスの長さは ICH IG の規格通りとする。
382
The maximum path length defined in the ICH eCTD v4.0 IG applies to the implementation in
383
Japan.
384
385
386
7.
eCTD に含まれるファイル形式に関する要件: Requirements for File
Formats for Japan eCTD Submission
387
ICH IG では eCTD に含めることが出来るファイル形式に係わる要件は定められていな
388
い。日本の審査当局に提出する eCTD では、提出できるファイル形式を以下に示す通り
389
とする。eCTD XML メッセージインスタンスから参照するファイルを、PDF 形式あるい
390
は Microsoft Excel 形式以外のファイル形式で提出する必要が生じた場合は、事前に審査
391
当局に相談すること。
392
・ 記述的：PDF（Portable Document File）
393
・ 一覧*：Microsoft Excel
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・ 構造化：XML（Extensible Markup Language）
395
・ グラフィック：可能な場合は常に PDF を用いる。次のフォーマットは、利用が適切
396
な場合、あるいは PDF が使用できない場合に利用する: JPEG（Joint Photographic
397
Experts Group）、PNG（Portable Network Graphics）、SVG（Scalable Vector Graphics）、
398
および GIF（Graphics Interchange Format）。場合によっては、超高解像度に対応した
399
特殊なフォーマット(DICOM 等)が適切なこともあり得る。
400
*：Module 1 に含まれる添付資料一覧、及び Module 5 に含まれる症例一覧表に限り、
401
Microsoft Excel 形式（.xls 又は.xlsx）も求める場合がある。
402
403
In the ICH IG, requirements for file formats that can be included in an eCTD are not specified.
404
Requirements for file formats in Japan are the following.
Consult PMDA if the format of the
405
file referenced from the eCTD XML message instance needs to be in the format other than PDF
406
or Microsoft Excel.
407
・ Narrative: Portable Document Format (PDF)
408
・ Tabulation*: Microsoft Excel
409
・ Structured: Extensible Markup Language (XML)
410
・ Graphic: Whenever possible, use PDF. When appropriate or when PDF is not possible, use
411
Joint Photographic Experts Group (JPEG), Portable Network Graphics (PNG), Scalable
412
Vector Graphics (SVG), and Graphics Interchange Format (GIF). Special formats for very
413
high resolutions (DICOM etc.) could be appropriate on a case-by-case basis.
414
415
*Microsoft Excel (i.e., .xls or .xlsx) may be required for the “List of attached documentation”
416
in Module 1 or the case report tabulations under Module 5.3.7 in addition to the PDF files.
417
418
eCTD に含まれる PDF ファイルに関する要件: Requirements for Japan
eCTD Submission Package - PDF
8.
419
420
PDF ファイル: PDF Files
8.1
ICH IG では PDF ファイルに係わる要件は定められていない。日本の審査当局に提出
421
422
する eCTD では、以下に示す仕様に基づき作成すること。
423
In the ICH IG, requirements for PDF files are not specified.
424
PDF files for eCTD submission
to PMDA should be created to meet the specifications in this section.
425
426
427
8.1.1
フォントの仕様: Fonts
1) 推奨フォント: Recommended Fonts
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日本語のフォントは Unicode 対応の MS ゴシック、MS 明朝又は中ゴシック、細明朝
429
とする。英語のフォントは Times New Roman、Arial、Courier および Acrobat 製品セット
430
自体でサポートされるフォントとする。
431
The unicode-supported MS Gothic, MS Mincho, Chu-Gothic and Sai-Mincho are
432
recommended for Japanese fonts.
Times New Roman, Arial, Courier and the fonts supported
433
by Acrobat product set itself are recommended for English fonts.
434
435
2) フォントサイズ: Font Size
日本語文書に使用する本文のフォントサイズは原則として 10.5 pt とする。図表等で使
436
437
用するフォントのサイズは 8 pt 以上（判読可能なサイズ）であれば使用出来る。
438
439
For Japanese font in documents, 10.5-point font should be used whenever possible. Japanese
font size 8pt and larger may be used in figures and tables when they are legible.
440
441
3) フォントカラー: Use of Color Fonts
442
黒のフォント色の使用が望ましい。黒色以外のフォント色を使用する場合は、グレイスケ
443
ール（白黒階調）プリンタで適切に印刷されない明るい色を避ける。背景に影をつけるのは
444
避ける。Text PDF に関しては、ハイパーテキスト・リンクには青色のフォントを使用するの
445
が望ましい。
446
The use of a black font color is recommended.
Light colors that do not print well on
447
grayscale printers should be avoided.
The use of background shadowing should be avoided.
448
In text PDF, blue font color is recommended for the text for hypertext links.
449
450
8.1.2
画像を含む PDF ファイル: PDF files containing images
451
画像を含む PDF ファイルを作成するときは、画像をダウンサンプルしないこと。ダウ
452
ンサンプリングでは元の画像の全ピクセルが保持されない。PDF 画像については、以下
453
の可逆圧縮 （lossless compression）の技術を用いる。
454
・ カラーおよびグレイスケール画像の可逆圧縮には、Zip/Flate（1 つの技術に 2 つの
455
名称がある）を用いる。同技術については Internet RFC 1950 および RFC 1951 に記
456
。
載されている （http://www.ietf.org/rfc/rfc1950.txt）
457
・ 白黒画像の可逆圧縮には、CCITT Group4 Fax 圧縮技術を使用する。同技術につい
458
ては CCITT 勧告 T.6（1988）－「グループ 4 ファクシミリ装置に対するファクシミ
459
リ・コーディング・スキームおよびコーディング制御機能」として仕様が定めら
460
れている。
461
When creating PDF files containing images, the images should not be downsampled.
462
Downsampling does not preserve all of the pixels in the original.
463
following lossless compression techniques should be used:
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• For lossless compression of color and grayscale images, use Zip/Flate (one technique with
464
465
two
names).
This
is
specified
466
(http://www.ietf.org/rfc/rfc1950.txt).
in
Internet
RFC
1950
and
RFC
1951
467
• For lossless compression of black and white images, use the CCITT Group 4 Fax
468
compression technique. It is specified as CCITT recommendations T.6 (1988) - Facsimile
469
coding schemes and coding control functions for Group 4 facsimile apparatus.
470
471
8.1.3
スキャン文書の解像度: Resolution of Scanned (Image) Document
472
スキャン文書は、文書の記述が判読できる解像度でスキャンする。
473
Documents that are available only in paper should be scanned at resolutions that will ensure
474
the pages are legible both on the computer screen and when printed.
475
476
8.1.4
ファイルサイズ: File Size
477
PDF ファイルは 100 メガバイト以下にすべきであ Web 表示用に最適化すること。1 文
478
書が 100 メガバイトを超える場合は、ファイルを分割し、同じ code 値を持つ Context of
479
Use からそれぞれ参照すること。このとき、ファイル間の前後関係を priorityNumber で
480
指定すること。Compound Document を構成するファイルが 100 メガバイトを超える場合
481
は、priorityNumber によってその前後関係を示すこと。いずれの場合も、title によって同
482
一目的のファイルであることが明確であることが望ましい。なお、100 メガバイトを超
483
えることのみを理由に Compound Document を作成することは適切ではない。
484
485
PDF files should be no larger than 100 megabytes, and beoptimized for fast web view.
486
When an electronic file exceeds 100MB, the file can be split into multiple files, and every file
487
should be referenced from a contextOfUse of the same code.
488
should be specified by the priotityNumber.
489
exceeds 100MB, the order of the files should be specified by the priorityNumber.
490
it is recommended that the document title describes that the files are for the same purpose.
491
Craeting a compound document only for the purpose of splitting a file exceeding 100MB is not
492
appropriate.
In such case, the order of the files
When a component of a compound document
In either case,
493
494
495
496
497
498
499
8.1.5
ハイパーテキスト・リンク及びブックマーク: Hypertext Linking and Bookmarks
• ハイパーテキスト・リンクは、細線の長方形で囲むか、青色のテキスト（推奨）
により指定できる。
• 文書本体から、同一ページ上にない注釈や関連セクション、参考文献、付録、表
または図へのハイパーリンクは有用であり、ナビゲーションの効率を向上させる。
• 別ファイルを参照するハイパーテキスト・リンクまたはブックマークを作成する
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場合は、相対パスを利用すること。ただし、相対パスは必ずトップレベル・フォ
501
ルダ名称を含むこと。
• ブックマークとハイパーリンクを作成する場合は、拡大設定の Inherit Zoom を使用
502
する。
503
• 目次付きの文書については、全ての表、図、出版物、その他の参考文献および付
504
録を含めて、目次に示された各項目に対するブックマークを提供すること。
505
• 申請文書またはモジュールの主要な目次にハイパーテキスト・リンクを作成する
506
ことは有用である。
507
• ブックマークの階層は目次と同様とし、目次の階層以上のブックマークのレベル
508
は設けない。
509
510
• ブックマークは、4 階層を超えない範囲での利用を推奨する
511
• Hypertext links can be designated by rectangles using thin lines or by blue text as
512
appropriate.
513
• Creating hypertext links throughout the document to support annotations, related sections,
514
reference literatures, appendices, tables, or figures that are not located on the same page is
515
useful and raises the efficiency of navigation.
• Relative paths should be used when creating hypertext links or bookmarks directing to
516
517
another file.
The path, however, should always include the top-level folder name i.e., the
518
path should trace up to the folder one level above the top-level folder and trace down from
519
there to the destination file.
• When creating bookmarks and hyperlinks, the magnification setting Inherit Zoom should
520
521
be used.
522
• For documents with a table of contents, bookmarks for each item listed in the table of
523
contents should be provided including all tables, figures, publications, other references,
524
and appendices.
525
• It is useful to create hypertext links to major table of contents of the dossier or modules.
526
• The bookmark hierarchy should be identical in the hierarchical level and order to the table
527
of contents with no additional bookmark levels beyond those present in the table of
528
contents.
• The use of no more than 4 levels in the hierarchy is recommended.
529
530
531
532
8.1.6
ページサイズ: Page Size
ページの印刷領域は A4 サイズ（210 x 297 mm）またはレターサイズ（8.5” x 11”）に
533
適合するように設定すること。審査員が、一時的な使用のためページを印刷して綴じる
534
際に、情報が隠れないように各ページの左側に十分なマージン（2.5cm 以上）を設ける。
535
横長の向きのページの場合は（例えば表や出版物の場合）、より多くの情報を当該ペー
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536
ジに表示するため、マージンはこれより少なくともよい（上側 2.0cm 以上、左右は 0.8cm
537
以上）。ヘッダとフッタ情報は、マージン内に印刷されるのは差し支えないが、端に寄
538
り過ぎて印刷からもれることのないように注意する。
539
The print area for pages should fit on a sheet of A4 (210 x 297 mm) and Letter (8.5” x 11”)
540
paper. A sufficient margin (at least 2.5 cm) on the left side of each page should be provided to
541
avoid obscuring information if the reviewer subsequently prints and binds the pages for
542
temporary use. For pages in landscape orientation (typically tables and publications), smaller
543
margins (at least 2.0 cm at the top and 0.8 cm left and right) allow more information to be
544
displayed legibly on the page (see Fonts). Header and footer information can appear within these
545
margins but should not appear so close to the page edge to risk being lost upon printing.
546
547
8.1.7
制限事項: Limitations and Restrictions
548
• セキュリティ設定またはパスワードによる保護は含めない。
549
• セキュリティ・フィールドは、印刷、文書に対する変更、テキストとグラフィッ
550
クスの選択、および注釈とフォーム・フィールドの追加や変更ができるように設
551
定する。
• ISO 32000-1:2008 に定義されている Annotation Type のうち、Link 以外は可能な限
552
り使用を避ける。
553
• ISO 32000-1:2008 に定義されている以下の機能は原則として使用しない。
554
555
GoTo 及び GoToR 以外の Action
556
Interactive Forms
557
Multimedia Features
558
• No security settings or password protection should be included.
559
• Security fields should be set to allow printing, changes to the document, selecting text and
560
graphics, and adding or changing notes and form fields.
• Use of any annotation type defined in ISO 32000-1:2008 should be avoided whenever
561
562
possible, except for Link annotation type.
• Use of any of the followings defined in ISO 32000-1:2008 should be avoided
563
564
Action, except for GoTo and GoToR
565
Interactive Forms
566
Multimedia Features
567
568
569
8.1.8
過去に作成された資料の取扱い: Handling of Existing Documents which Created in
the Past
570
第 3 部、第 4 部、第 5 部に添付する報告書等のうち、平成 18 年 3 月以前に紙媒体と
571
してすでに作成された資料は、判読可能であれば、スキャニングにより作成した PDF を
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eCTD に含めて差し支えない。原則として、それ以降に作成される資料に関しては、電
573
子ファイルから PDF ファイル（テキスト PDF）を作成すること。
574
It is acceptable to include the reports in Module 3, 4, or 5 as scanned PDF files in the eCTD
575
submission package if they have already been created in paper format prior to March 2006 and if
576
the scanned PDF files are legible.
577
converted from electronic file.
Any document created since then should be the PDF file
578
579
8.1.9
Excel ファイルの提出を求められた PDF 資料の取り扱い
580
PDF ファイルに加え、Microsoft Excel 形式のファイルの提出を求められた場合、PDF
581
ファイルは、Excel ファイルと見た目などを完全に一致させる必要はない。ただし、両
582
形式のファイル間で内容の矛盾が生じないこと。
583
When files in Microsoft Excel format are requested to be submitted in addition to the PDF
584
files, the PDF files do not absolutely need to be visually identical to the Excel files. However,
585
there should be no inconsistency in the contents between the two formats.
586
587
9.
588
589
9.1
eCTD に含まれるインスタンスに関する要件: Requirements for Japan
eCTD Submission Package – eCTD XML Message Instance
キャラクターエンコード: Character Encoding
590
UTF-8 を用いる。
591
UTF-8 is used.
592
593
9.2
値を持たない要素及び属性の取り扱い
Element / Attribute without meaningful
value
594
日本向けの eCTD v4.0 Message Instance の Payload において、integrityCheck 要素を除く
595
596
その他の要素に値を持たせることは認められない。また、値を持たない integrityCheck
597
要素及びダミー値を持たせた integrityCheck 要素を提出することは認められない。属性値
598
については、値を持たない属性及びダミー値を持たせた属性を提出することは、認めら
599
れない。
600
In the payload of eCTD v4.0 Message Instance for Japan, no element can have element value
601
except for integrityCheck element. The integrityCheck element cannot be provided when it has
602
dummy value or no value. No attribute can be provided if it has dummy value or no value.
603
604
9.3
日本固有の要素／属性の使用方法: eCTD Operation in Japan
605
eCTD v4.0 XML Message Instance は、日本では使用しない要素/属性、使用方法が他極
606
と使用方法が異なる要素/属性、及び日本のみで使用する要素/属性を含む。日本向けの
607
eCTD v4.0 XML Message Instance についての詳細は 16.4 を参照のこと。
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608
以下の項は、ICH IG を補完する。特に記載がある場合を除き、ICH IG の内容に従う
609
こと。ICH IG の内容と異なる記載がある場合は、日本における eCTD 申請においては、
610
本実装ガイドの内容を優先すること。
611
The eCTD XML Message Instance include the elements/attributes not used in Japan, the
612
elements/attributes whose usage differ from other ICH regions, and the elements/attributes used
613
only in Japan.
614
subsections complement the ICH IG.
615
instructed here.
616
eCTD submission in Japan if there is difference between the two guides on the same item.
See section 16.4 for details of JP eCTD XML Message Instance.The following
Follow the instruction in the ICH IG unless otherwise
The instruction in this guide should take precedence over the ICH IG for the
617
618
9.3.1
applicant
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
applicant
Description
Instructions
The number of applicant
element should be identical
to the number of applicants
identified
on
the
Application
Form
identified by the review
that the applicant is
associated. When there
are multiple applicants, its
superordinate
holder
element repeats.
[1..1]
sponsorOrga
nization
name
xsi:type
[1..1]
[1..1]
DSET_EN
e.g.,
xsi:type=”DSET_E
N”
item
part
value
[1..1]
[1..1]
[1..1]
Alpha Numeric +
Japanese characters
xsi:type=”DSET_EN”
defines that the applicants
are discrete and distinct.
Applicant name
e.g.,
extension=”JPMA
製薬株式会社”
Conformance
Business Rules
applicant element must be provided in initial sequence.
Only “DEST_EN” can be used for the name@xsi:type value
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Element
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
The following elements and attributes cannot be used in eCTD v4.0 Message
Instance in Japan.
applicant.realmCode
applicant.typeId
applicant.templateId
applicant@classCode
applicant@nullFlavor
applicant.sponsorOrganization.realmCode
applicant.sponsorOrganization.typeId
applicant.sponsorOrganization.templateId
applicant.sponsorOrganization.id
applicant.sponsorOrganization.telecom
applicant.sponsorOrganization.addr
applicant.sponsorOrganization@nullFlavor
applicant.sponsorOrganization@classCode
applicant.sponsorOrganization@determinerCode
applicant.sponsorOrganization.name@validTimeLow
applicant.sponsorOrganization.name@validTimeHigh
applicant.sponsorOrganization.name@controlInformationRoot
applicant.sponsorOrganization.name@controlInformationExtension
applicant.sponsorOrganization.name@nullFlavor
applicant.sponsorOrganization.name@flavorId
applicant.sponsorOrganization.name@updateMode
applicant.sponsorOrganization.name.item@validTimeLow
applicant.sponsorOrganization.name.item@validTimeHigh
applicant.sponsorOrganization.name.item@controlInformationRoot
applicant.sponsorOrganization.name.item@controlInformationExtensi
on
applicant.sponsorOrganization.name.item@nullFlavor
applicant.sponsorOrganization.name.item@flavorId
applicant.sponsorOrganization.name.item@updateMode
applicant.sponsorOrganization.name.item@use
applicant.sponsorOrganization.name.item.part@type
applicant.sponsorOrganization.name.item.part@qualifier
applicant.sponsorOrganization.name.item.part@nullFlavor
applicant.sponsorOrganization.name.item.part@code
applicant.sponsorOrganization.name.item.part@codeSystem
applicant.sponsorOrganization.name.item.part@codeSystemVersion
applicant.sponsorOrganization.name.item.part@language
619
620
9.3.2
application
Element
Attribute
application
id
item
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Cardinality
Value(s) Allowed
Examples
Description
Instructions
[1..1]
[1..1]
[1..1]
Page 20 of 126
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CONFIDENTIAL
Element
Attribute
Cardinality
Value(s) Allowed
Examples
root
[1..1]
Valid UUID
[1..1]
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
Alpha Numeric
extension
Description
Instructions
A
universally
identifier
of
application.
unique
this
eCTD Receipt Number
e.g.,
extension=”24050
5001”
code
code
codeSystem
[1..1]
[1..1]
Alpha Numeric
[1..1]
eg.,
code=”JP-MAA”
Valid OID
A coded value that
indicates the type of this
application.
The OID of JP Application
Code.
e.g., codeSystem=”
2.16.840.1.113883.
3.989.2
reference
[0..*]
component
[0..*]
referencedBy
[0..*]
This element is provided
when
providing
applicationReference
element as its subordinate
element. One reference
element can contain only
one applicationReference
element. See 9.3.3 for
details.
This element is provided
when providing document
element as its subordinate
element. One component
element can contain only
one document element.
See 9.3.6 for details.
This element is provided
when
providing
keywordDefinition
element as its subordinate
element.
One
referencedBy element can
contain
only
one
keywordDefinition
element. See 9.3.10 for
details.
Conformance
For Step2 For Testing
Page 21 of 126
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CONFIDENTIAL
Element
Business Rules
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
Only one id.item element can be provided in one sequence.
id.item@extension attribute value must be provided.
id.item@root and id.item@extension value should stay the same through the
entire life cycle of this application.
Any of the elements or attributes defined in the ICH IG as excluded elements
and/or attributes cannot be used in eCTD v4.0 Message Instance for Japan.
In addition, the following elements cannot be used in eCTD v4.0 Message
Instance in Japan.
application.holder
application.informationRecipient
application.subject
621
622
9.3.3
applicationReference
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
applicationRefe
ference
id
root
[1..1]
[1..1]
applicationRefernce
element is provided when
there is one or more eCTD
submission related to this
eCTD submission. When
there are multiple related
applications,
the
superordinate
reference
element repeats.
UUID of related
application
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
[1..1]
[1..*]
reasonCode
item
code
[1..1]
Alpha Numeric
eg., code=”
JP-Ichihen”
For Step2 For Testing
Description
Instructions
Page 22 of 126
The
application.id.item@root
value of the related
application.
When there are multiple
relationships,
reasonCode.item element
repeats.
A coded value that
indicates the type of the
relationship between this
application
and
the
application referenced by
applicationReference.id@
root value.
Ver:0.11
CONFIDENTIAL
Element
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
codeSystem
[1..1]
Valid OID
The OID of JP Application
Reference Reason code
list.
e.g., codeSystem=”
2.16.840.1.113883.
3.989.2
Conformance
Business Rules
reasonCode element must be provided when providing applicationReference.
For Step2 For Testing
Page 23 of 126
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CONFIDENTIAL
Element
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
The following elements and attributes cannot be used in eCTD v4.0 Message
Instance in Japan.
applicationReference.realmCode
applicationReference.typeId
applicationReference.templateId
applicationReference@classCode
applicationReference@moodCode
applicationReference@nullFlavor
applicationReference.id@validTimeLow
applicationReference.id@validTimeHigh
applicationReference.id@controlInformationRoot
applicationReference.id@controlInformationExtension
applicationReference.id@nullFlavor
applicationReference.id@flavorId
applicationReference.id@updateMode
applicationReference.id@extension
applicationReference.id@identifierName
applicationReference.id@displayable
applicationReference.id@scope
applicationReference.id@reliability
applicationReference.reasonCode@validTimeLow
applicationReference.reasonCode@validTimeHigh
applicationReference.reasonCode@controlInformationRoot
applicationReference.reasonCode@controlInformationExtension
applicationReference.reasonCode@nullFlavor
applicationReference.reasonCode@flavorId
applicationReference.reasonCode@updateMode
applicationReference.reasonCode.item.displayName
applicationReference.reasonCode.item.originalText
applicationReference.reasonCode.item.translation
applicationReference.reasonCode.item.source
applicationReference.reasonCode.item@codeSystemName
applicationReference.reasonCode.item@codeSystemVersion
applicationReference.reasonCode.item@valueSet
applicationReference.reasonCode.item@valueSetVersion
applicationReference.reasonCode.item@codingRationale
applicationReference.reasonCode.item@id
applicationReference.reasonCode.item@validTimeLow
applicationReference.reasonCode.item@validTimeHigh
applicationReference.reasonCode.item@controlInformationRoot
applicationReference.reasonCode.item@controlInformationExtension
applicationReference.reasonCode.item@nullFlavor
applicationReference.reasonCode.item@flavorId
applicationReference.reasonCode.item@updateMode
623
For Step2 For Testing
Page 24 of 126
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624
9.3.4
categoryEvent
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
categoryEvent
code
code
codeSystem
Description
Instructions
categoryEvent element is
provided to specify which
step in the review process
the submission unit is for.
Since one submission unit
can be applied to only one
review
step,
the
superordinate
subject
element cannot repeat.
[1..1]
[1..1]
Alpha Numeric
[1..1]
eg., code=”
JP-First”
Valid OID
A coded value that
indicates step in the review
process the submission
unit is for.
The OID of JP Category
Event code list.
e.g., codeSystem=”
2.16.840.1.113883.
3.989.2
Conformance
Business Rules
Excluded
Elements
and/or
Attributes
categoryEvenr element must be provided in every sequence.
The following elements and attributes cannot be used in eCTD v4.0 Message
Instance in Japan.
categoryEvent.realmCode
categoryEvent.typeId
categoryEvent.templateId
categoryEvent.subjct
categoryEvent@classCode
categoryEvent@moodCode
categoryEvent@nullFlavor
categoryEvent.code.displayName
categoryEvent.code.originalText
categoryEvent.code.translation
categoryEvent.code.source
categoryEvent.code@codeSystemName
categoryEvent.code@codeSystemVersion
categoryEvent.code@valueSet
categoryEvent.code@valueSetVersion
categoryEvent.code@codingRationale
categoryEvent.code@id
categoryEvent.code@validTimeLow
categoryEvent.code@validTimeHigh
categoryEvent.code@controlInformationRoot
categoryEvent.code@controlInformationExtension
categoryEvent.code@flavorId
categoryEvent.code@nullFlavor
categoryEvent.code@updateMode
625
For Step2 For Testing
Page 25 of 126
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CONFIDENTIAL
626
627
9.3.5
contextOfUse
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
contextOfUse
id
root
[1..1]
[1..1]
When there are multiple
context of uses, the
superordinate component
element repeats.
Valid UUID
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
code
code
codeSystem
[1..1]
[1..1]
Alpha Numeric
[1..1]
eg.,
code=”JP-m1.01”
Valid OID
e.g.,
codeSystem=”2.16.
840.1.113883.3.989
.2”
statusCode
[1..1]
active or inactive
e.g., statusCode=
”inactive”
setId
root
[1..1]
[1..1]
Valid UUID
e.g.,
root=”2.16.840.1.1
13883.3.989.2”
value
[0..1]
[1..1]
Numeric
e.g.,
versionNumber=”1
”
For Step2 For Testing
A
universally
identifier
of
contextOfUse.
unique
this
A coded value that
indicates to which CTD
section the referencing
document locates.
The OID of JP Context of
Use Code (for Module 1
documents)
or
ICH
Context of Use Code (for
Module 2-5 documents).
[1..1]
code
versionNumb
er
Description
Instructions
Page 26 of 126
The value is “active” when
providing the Context of
Use, and is “inactive”
when
removing
the
Context of Use.
A unique identifier of the
set to which this CoU
belongs.
An integer that identifies
the version of the CoU in
the defined set.
Ver:0.11
CONFIDENTIAL
Element
Attribute
Cardinality
sequelTo
[0..*]
derivedFrom
[0..1]
referencedBy
[0..*]
Conformance
Business Rules
Excluded
Elements
and/or
Attributes
Value(s) Allowed
Examples
Description
Instructions
This element is provided
when
providing
relatedContextOfUse
element as its subordinate
element.
One sequelTo
element can contain only
one relatedContextOfUse
element. See 9.3.16 for
details. When there are
multiple
relatedContextOfUse, this
element repeats.
This element is provided
when
providing
documentReference
element as its subordinate
element.
One
derivedFrom element can
contain
only
one
documentReference
element. See 9.3.7 for
details.
This element is provided
when providing keyword
element as its subordinate
element.
One
referencedBy element can
contain only one keyword
element. See 9.3.9 for
details. When there are
multiple keywords, thie
element repeats.
versionNumber element is required, except for the case of removing the CoU.
The id@root value should never be reused.
Only one version of the same setId@root should be active in the same
Application.
The setId@root for the first version of a Context of Use should be used for all
subsequent versions of that CoU within an Application if they are in the same
context. If there is no relationship between the document referenced by the
current CoU and the document referenced by previously submitted CoU, the
setId@root should be different.
Any of the elements or attributes defined in the ICH IG as excluded elements
and/or attributes cannot be used in eCTD v4.0 Message Instance for Japan.
628
629
9.3.6
document
Element
Attribute
For Step2 For Testing
Cardinality
Value(s) Allowed
Examples
Page 27 of 126
Description
Instructions
Ver:0.11
CONFIDENTIAL
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
document
id
root
[1..1]
[1..1]
Description
Instructions
When there are multiple
documents,
the
superordinate component
element repeats.
Valid UUID
A
universally
unique
identifier of this document.
e.g.,
root=” 365896527894-6589-3256-3
21852697531”
code
[0..1]
[1..1]
Alpha Numeric
codeSystem
[1..1]
eg., code=”ich-2”
Valid OID
code
A coded value that
indicates the type of this
document.
The OID of ICH Document
Code.
e.g.,
codeSystem=”2.1
6.840.1.113883.3.9
89.2
title
value
updateMod
e
[0..1]
[1..1]
Alpha Numeric
[0..1]
e.g.,
value=“General I
nformation”
R
e.g.,
updateMode=”R”
text
integrityCh
eckAlgorith
m
reference
value
[0..1]
[1..1]
[1..1]
[1..1]
SHA256
This is the type of
integrityCheckAlgorithm
e.g.,
that was used for the
integrityCheckAlg checksum values provided
orithm=”SHA256” in integrityCheck element.
Only “SHA256” can be
used.
Alpha Numeric
e.g.,
value=“../../../top-l
evel-folder/secondlevel-folder/m3/32body-data/32s-dru
g-sub/32s1-gen-inf
o.pdf”
For Step2 For Testing
A
sender-specified,
human-readable title of this
document. The value will
be displayed on the
viewing tool.
When the title is changed
through
life
cycle,
updateMode=”R”
is
provided.
Page 28 of 126
The file path to the file
referenced
by
the
document.
Ver:0.11
CONFIDENTIAL
Element
Attribute
integrityC
heck
Cardinality
Value(s) Allowed
Examples
Description
Instructions
[1..1]
Alpha Numeric
The SHA256 checksum
value of the file referenced
by the document.
e.g.,
<integrityCheck>6
18102bf07065bcc1
250594201fe44851
5f0fa61</integrity
Check>
setId
root
[0..1]
[1..1]
Valid UUID
e.g.,
root=” 365896527894-6589-3256-3
21852697531”
versionNumb
er
value
[0..1]
[1..1]
Numeric
e.g.,
versionNumber=”
1”
component
[0..*]
referencedBy
[0..*]
A unique identifier of the
set to which this document
belongs.
An integer that identifies
the
version
of
the
document in the defined
set.
This element is provided
when providing document
element as its subordinate
element (i.e., compound
document)
One
component element can
contain only one document
element. When there are
multiple
component
dopcuments, this element
repeats. The details of the
subordinate document are
the same as the document
described in this section.
This element is provided
when providing keyword
element as its subordinate
element.
One
referencedBy element can
contain only one keyword
element.
See 9.3.9 for
details. When there are
multiple keywords, this
element repeats.
Conformance
For Step2 For Testing
Page 29 of 126
Ver:0.11
CONFIDENTIAL
Element
Business Rules
Excluded
Elements and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
title@updateMode can only have “R” as its value.
text.reference@value has to include the name of the top level folder.
Only one version of the same setId@root should be active in the same
Application.
The study reports in Module 4 and 5 should always be compound document;
however, the STF-derived document code or keyword should not be used. The
document code should be “ich-1” for Module 4 study reports, and “ich-2” for
Module 5 study reports.
Any document in Module 1, 2, or 3 should not be compound document.
Any of the elements or attributes defined in the ICH IG as excluded elements
and/or attributes cannot be used in eCTD v4.0 Message Instance for Japan.
In addition, the following attribute cannot be used in eCTD v4.0 Message
Instance for Japan.
document.text@language
document.text@updateMode
630
631
9.3.7
documentReference
Element
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
[1..1]
documentRefere
nce
id
root
[1..1]
[1..1]
Valid UUID
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
Conformance
Business Rules
Excluded
Elements
and/or
Attributes
When reusing document, only the id of the document submitted in approved
submission can be provided as documentReference.id@root value. Also note
that the documents whose official retention period are expired can not be reused.
Any of the elements or attributes defined in the ICH IG as excluded elements
and/or attributes cannot be used in eCTD v4.0 Message Instance for Japan.
632
633
9.3.8
ingredient
Element
Attribute
ingredient
For Step2 For Testing
Cardinality
Value(s) Allowed
Examples
[1..*]
Page 30 of 126
Description
Instructions
ingredient element is
provided to indicate the
active ingredient(s) of this
product. When multiple
active ingredients exist,
this element repeats.
Ver:0.11
CONFIDENTIAL
Element
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
Alpha
Numeric+Japanese
Character
The name of the active
ingredient in JAN.
[1..1]
activeIngredi
entSubstance
name
part
value
[1..1]
[1..1]
[1..1]
eg., value=”イー
アイ塩酸塩”
Conformance
Business Rules
Excluded
Elements
and/or
Attributes
ingredient element must be provided in the initial sequence.
The following elements and attributes cannot be used in eCTD v4.0 Message
Instance in Japan.
ingredient.realmCode
ingredient.typeId
ingredient.templateId
ingredient@classCode
ingredient@nullFlavor
ingredient.activeIngredientSubstance.realmCode
ingredient.activeIngredientSubstance.typeId
ingredient.activeIngredientSubstance.templateId
ingredient.activeIngredientSubstance@classCode
ingredient.activeIngredientSubstance@determinerCode
ingredient.activeIngredientSubstance.name@validTimeLow
ingredient.activeIngredientSubstance.name@validTimeHigh
ingredient.activeIngredientSubstance.name@controlInformationRoot
ingredient.activeIngredientSubstance.name@controlInformationExten
sion
ingredient.activeIngredientSubstance.name@flavored
ingredient.activeIngredientSubstance.name@nullFlavor
ingredient.activeIngredientSubstance.name@updateMode
ingredient.activeIngredientSubstance.name@use
ingredient.activeIngredientSubstance.name.part@code
ingredient.activeIngredientSubstance.name.part@codeSystem
ingredient.activeIngredientSubstance.name.part@codeSystemVersion
ingredient.activeIngredientSubstance.name.part@language
ingredient.activeIngredientSubstance.name.part@nullFlavor
ingredient.activeIngredientSubstance.name.part@qualifier
ingredient.activeIngredientSubstance.name.part@type
634
635
9.3.9
keyword
636
keyword の使用方法は ICH IG と相違ない。ICH IG を参照すること。
637
There is no difference in the use of keyword from the definition of ICH IG.
638
Refer to ICH IG
for details.
639
For Step2 For Testing
Page 31 of 126
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CONFIDENTIAL
640
9.3.10
keywordDefinition
641
keywordDefinition の使用方法は ICH IG と相違ない。ICH IG を参照すること。
642
There is no difference in the use of keywordDefinition from the definition of ICH IG.
643
Refer
to ICH IG for details.
644
645
9.3.11 manufacturedProduct
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
manufacturedPr
oduct
Description
Instructions
manufacturedProduct
element is provided to
provide
product
information covered by the
Application Form. There
can be only one product
information per review can
be provided.
[1..1]
manufacture
dProduct
name
xsi:type
[1..1]
[1..1]
DSET_EN
e.g.,
xsi:type=”DSET_
EN”
item
part
value
[1..1]
[1..1]
[1..1]
Alpha
Numeric+Japanese
Character
xsi:type=”DSET_EN”
defines that the product
name is discrete and
distinct.
The brand name of the
product.
eg., value=”セイ
ヤクキョール錠
10mg”
ingredient
[0..*]
This element is provided
when
providing
the
information of the active
ingredient of this product
by
providing
activeIngredientSubstance
element as its subordinate
element. One ingredient
element
can
contain
multiple
manufacturedProduct
elements as needed. See
9.3.8 for details. When
there
are
multiple
ingredients, this element
repeats.
Conformance
For Step2 For Testing
Page 32 of 126
Ver:0.11
CONFIDENTIAL
Element
Business Rules
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
manufacturedProduct element must be provided in the initial sequence.
Only “DEST_EN” can be used for the name@xsi:type value
The following elements and attributes cannot be used in eCTD v4.0 Message
Instance in Japan.
manufacturedProduct.realmCode
manufacturedProduct.typeId
manufacturedProduct.templateId
manufacturedProduct.id
manufacgtureProduct@classCode
manufacturedProduct@nullFlavor
manufacturedProduct.manufacturedProduct.realmCode
manufacturedProduct.manufacturedProduct.typeId
manufacturedProduct.manufacturedProduct.templateId
manufacturedProduct.manufacturedProduct.asNamedEntity
manufacgtureProduct.manufacturedProduct@classCode
manufacgtureProduct.manufacturedProduct@determinerCode
manufacturedProduct.manufacturedProduct.name@validTimeLow
manufacturedProduct.manufacturedProduct.name@validTimeHigh
manufacturedProduct.manufacturedProduct.name@controlInformatio
nRoot
manufacturedProduct.manufacturedProduct.name@controlInformatio
nExtension
manufacturedProduct.manufacturedProduct.name@nullFlavor
manufacturedProduct.manufacturedProduct.name@flavorId
manufacturedProduct.manufacturedProduct.name@updateMode
manufacturedProduct.manufacturedProduct.name.item@validTimeLo
w
manufacturedProduct.manufacturedProduct.name.item@validTimeHi
gh
manufacturedProduct.manufacturedProduct.name.item@controlInfor
mationRoot
manufacturedProduct.manufacturedProduct.name.item@controlInfor
mationExtension
manufacturedProduct.manufacturedProduct.name.item@nullFlavor
manufacturedProduct.manufacturedProduct.name.item@flavorId
manufacturedProduct.manufacturedProduct.name.item@updateMode
manufacturedProduct.manufacturedProduct.name.item@use
manufacturedProduct.manufacturedProduct.name.item.part@type
manufacturedProduct.manufacturedProduct.name.item.part@qualifier
manufacturedProduct.manufacturedProduct.name.item.part@nullFlav
or
manufacturedProduct.manufacturedProduct.name.item.part@code
manufacturedProduct.manufacturedProduct.name.item.part@codeSyst
em
manufacturedProduct.manufacturedProduct.name.item.part@codeSyst
emVersion
manufacturedProduct.manufacturedProduct.name.item.part@languag
e
646
For Step2 For Testing
Page 33 of 126
Ver:0.11
CONFIDENTIAL
647
9.3.12
previousKeywordDefinition
648
previouKeywordDefinition の使用方法は ICH IG と相違ない。ICH IG を参照すること。
649
There is no difference in the use of previousKeywordDefinition from the definition of ICH IG.
650
Refer to ICH IG for details.
651
652
9.3.13
priorityNumber.contextOfUse
653
priorityNumber.contentOfUse の使用方法は ICH IG と相違ない。ICH IG を参照すること。
654
There is no difference in the use of priorityNumber.contextOfUse from the definition of ICH
655
IG.
Refer to ICH IG for details.
656
657
9.3.14
priorityNumber.document
658
priorityNumber.document の使用方法は ICH IG と相違ない。ICH IG を参照すること。
659
There is no difference in the use of priorityNumber.document from the definition of ICH IG.
660
Refer to ICH IG for details.
661
662
9.3.15 productCategory
Element
Attribute
Cardinality
Value(s) Allowed
Examples
[1..1]
productCategor
y
code
code
codeSystem
Description
Instructions
productCategory element
is provided to specify the
category of application.
The number and value of
productCategory must be
identical to the category of
application specified in the
Application Form. When
there
are
multiple
categories of application,
the superordinate subject2
repeats.
[1..1]
[1..1]
Alpha Numeric
[1..1]
eg., code=”
JP-01-01”
Valid OID
A coded value that
indicates the category of
application.
The OID of JP Product
Category Code.
e.g., codeSystem=”
2.16.840.1.113883.
3.989.2
Conformance
Business Rules
productCategory element must be provided in the initial sequence.
For Step2 For Testing
Page 34 of 126
Ver:0.11
CONFIDENTIAL
Element
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
The following elements and attributes cannot be used in eCTD v4.0 Message
Instance in Japan.
productCategory.realmCode
productCategory.typeId
productCategory.templateId
productCategory@classCode
productCategory@moodCode
productCategory@nullFlavor
productCategory.code.displayName
productCategory.code.originalText
productCategory.code.translation
productCategory.code.source
productCategory.code@codeSystemName
productCategory.code@codeSystemVersion
productCategory.code@codingRationale
productCategory.code@id
productCategory.code@valueSet
productCategory.code@valueSetVersion
productCategory.code@validTimeLow
productCategory.code@validTimeHigh
productCategory.code@controlInformationRoot
productCategory.code@controlInformationExtension
productCategory.code@nullFlavor
productCategory.code@flavorId
productCategory.code@updateMode
663
664
9.3.16
relatedContextOfUse
665
relatedContextOfUse の使用方法は ICH IG と相違ない。ICH IG を参照すること。
666
There is no difference in the use of relatedContextOfUse from the definition of ICH IG.
667
Refer to ICH IG for details.
668
669
9.3.17 review
Element
Attribute
Cardinality
review
[1..1]
id
[1..1]
For Step2 For Testing
Value(s) Allowed
Examples
Page 35 of 126
Description
Instructions
The number of review
element should be identical
to
the
number
of
Application Form covered
by this eCTD submission.
When there need to be
multiple review elements,
its superordinate subject2
element repeats.
Ver:0.11
CONFIDENTIAL
Element
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
root
[1..1]
Valid UUID
A
universally
unique
identifier of this review.
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
statusCode
code
[0..1]
[1..1]
active or inactive
eg., code=”active”
updateMod
e
[0..1]
R
e.g.,
updateMode=”R”
effectiveTime
value
[0..1]
[1..1]
subject1
[0..1]
holder
[0..*]
For Step2 For Testing
yyyymmdd
e.g., codeSystem=”
20120503”
Page 36 of 126
The value is “inactive”
only
when
multiple
application forms exist and
withdrawing one or more
(but not all) application
forms.
Otherwise the
value is “active”.
This attribute is provided
with a value “R” only
when
the
statusCode@code has a
value of “inactive”.
Submission Date
This element is provided
when
providing
manufacturedProduct
element as its subordinate
element.
One subject1
element can contain only
one manufacturedProduct
element. See 9.3.11 for
details.
This element is provided
when providing applicant
element as its subordinate
element.
One holder
element can contain only
one applicant element.
See 9.3.1 for details.
When there are multiple
applicants, this element
repeats.
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Element
Attribute
Value(s) Allowed
Examples
[0..*]
subject2
Conformance
Business Rules
Cardinality
Description
Instructions
This element is provided
when
providing
productCategory element
as its subordinate element.
One subject2 element can
contain
only
one
productCategory element.
See 9.3.15 for details.
When there are multiple
product categories, this
element repeats.
review.statusCode@updateMode can only have “R” as its value.
id, statusCode, effectiveTime, subject1, holder, and subject2 elements must be
provided in initial sequence.
id@root must be provided when providing review element.
id@root value should stay the same through the entire life cycle of this
submission.
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Element
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
The following elements and attributes and attributes cannot used in eCTD XML
Message Instance in Japan:
For Step2 For Testing
review.realmCode
review.typeId
review.templateId
review.author
review.subject1.dedicatedServiceDeliveryLocation
review@classCode
review@moodCode
review@nullFlavor
review.id@extension
review.id@identifierName
review.id@scope
review.id@reliability
review.id@displayable
review.id@validTimeLow
review.id@validTimeHigh
review.id@controlInformationRoot
review.id@controlInformationExtension
review.id@nullFlavor
review.id@flavorId
review.id@updateMode
review.statusCode.part
review.statusCode@validTimeLow
review.statusCode@validTimeHigh
review.statusCode@controlInformationRoot
review.statusCode@controlInformationExtension
review.statusCode@nullFlavor
review.statusCode@flavorId
review.effectiveTime.expression
review.effectiveTime.originalText
review.effectiveTime.uncertainty
review.effectiveTime.uncertainRange
review.effectiveTime@uncertaintyType
review.effectiveTime@validTimeLow
review.effectiveTime@validTimeHigh
review.effectiveTime@controlInformationRoot
review.effectiveTime@controlInformationExtension
review.effectiveTime@nullFlavor
review.effectiveTime@flavorId
review.effectiveTime@updateMode
review.subject1.realmCode
review.subject1.typeId
review.subject1.templateId
review.subject1.dedicatedServiceDeliveryLocation
review.subject1@nullFlavor
review.subject1@typeCode
review.holder.realmCode
review.holder.typeId
review.holder.templateId
review.holder@nullFlavor
review.holder@typeCode
review.subject2.realmCode
review.subject2.typeId
review.subject2.templateId
review.subject2@nullFlavor
review.subject2@typeCode
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670
671
9.3.18
sequenceNumber.submission
672
sequenceNumber.submission の使用方法は ICH IG と相違ない。ICH IG を参照すること。
673
There is no difference in the use of sequenceNumberSubmission from the definition of ICH
674
IG.
Refer to ICH IG for details.
675
676
9.3.19 submission
Element
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
[1..1]
[1..1]
submission
id
item
root
extension
[1..1]
Valid UUID
[1..1]
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
Alpha Numeric
A
universally
identifier
of
submission.
unique
this
eCTD Receipt Number
e.g.,
extension=”24050
5001”
code
code
codeSystem
[1..1]
[1..1]
Alpha Numeric
[1..1]
eg.,
code=”JP-Original
”
Valid OID
A coded value that
indicates whether this
submission is original or
reference.
The OID of JP Submission
Code.
e.g., codeSystem=”
2.16.840.1.113883.
3.989.2
[0..*]
subject2
Conformance
Business Rules
This element is provided
when providing review
element as its subordinate
element.
One subject2
element can contain only
one review element. See
9.3.17 for details. When
there are multiple products
for marketing approval,
this element repeats.
Only one id.item element can be provided in one sequence.
id.item@extension attribute value must be provided.
id.item@root and id.item@extension value should stay the same through the
entire life cycle of this submission.
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Element
Excluded
Elements
and/or
Attributes
Attribute
Cardinality
Value(s) Allowed
Examples
Description
Instructions
The following elements and attributes and attributes cannot used in eCTD XML
Message Instance in Japan:
submission.realmCode
submission.typeId
submission.templateId
submission.callBackContact
submission.subject1
submission.subject3
submission.subject4
submission.subject5
submission.componentOf.reviewableUnit
submission@classCode
submission@moodCode
submission@nullFlavor
submission.id@validTimeLow
submission.id@validTimeHigh
submission.id@controlInformationRoot
submission.id@controlInformationExtension
submission.id@nullFlavor
submission.id@flavorId
submission.id@updateMode
submission.id.item@validTimeLow
submission.id.item@validTimeHigh
submission.id.item@controlInformationRoot
submission.id.item@controlInformationExtension
submission.id.item@flavorId
submission.id.item@nullFlavor
submission.id.item@updateMode
submission.id.item@identifierName
submission.id.item@displayable
submission.id.item@scope
submission.id.item@reliability
submission.code.displayName
submission.code.originalText
submission.code.translation
submission.code.source
submission.code@codeSystemName
submission.code@codeSystemVersion
submission.code@valueSet
submission.code@valueSetVersion
submission.code@codingRationale
submission.code@validTimeLow
submission.code@validTimeHigh
submission.code@controlInformationRoot
submission.code@controlInformationExtension
submission.code@nullFlavor
submission.code@flavorId
submission.code@updateMode
submission.code@id
submission.subject2.realmCode
submission.subject2.typeId
submission.subject2.templateId
submission.subject2@nullFlavor
submission.subject2@typeCode
677
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678
9.3.20 submissionUnit
Element
Attribute
submissionUnit
id
root
extension
Cardinality
Value(s) Allowed
Examples
[1..1]
[1..1]
[1..1]
Valid UUID
[1..1]
e.g.,
root=”
36589652-7894-65
89-3256-32185269
7531”
Alpha Numeric
e.g.,
extension=”24050
5001-0001”
code
code
codeSystem
[1..1]
[1..1]
Alpha Numeric
[1..1]
eg.,
code=”JP-Official
”
Valid OID
Description
Instructions
A
universally
identifier
of
submissionUnit.
unique
this
The value is composed of
the eCTD Receipt Number
and Sequence Number
connected by a hyphen.
A coded value that
indicates whether this
submission unit is official
or draft.
The OID of JP Submission
Unit Code.
e.g., codeSystem=”
2.16.840.1.113883.
3.989.2
subject
[0..1]
component
[0..*]
For Step2 For Testing
Page 41 of 126
This element is provided
when
providing
categoryEvent element as
its subordinate element.
One subject element can
contain
only
one
categoryEvent
element.
See 9.3.4 for details.
This element is provided
when
providing
contextOfUse element as
its subordinate element.
One component element
can contain only one
contextOfUse
element.
See 9.3.5 for details.
When there are multiple
context of uses, this
element repeats.
Ver:0.11
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Element
Attribute
Cardinality
[1..1]
componentO
f
Conformance
Business Rules
Excluded
Elements
and/or
Attributes
Value(s) Allowed
Examples
Description
Instructions
This element is provided
when
providing
submission element as its
subordinate
element.
One componentOf element
can contain only one
submission element. See
9.3.19 for details.
id@extension attribute value must be provided and unique for every
submissionUnit.
A submission unit can contain only one submission in Japan.
submissionUnit.statusCode is not used in Japan and is always considered to be
active. Consult PMDA when you need to withdraw a submissionUnit.
Any of the elements or attributes defined in the ICH IG as excluded elements
and/or attributes cannot be used in eCTD v4.0 Message Instance for Japan, except
for id@extension.
In addition, the following element cannot be used in eCTD v4.0 Message
Instance for Japan.
submissionUnit.title
submissionUnit.statusCode
submissionUnit.callBackContact
submissionUnit.componentOf.reviewableUnit
679
680
日本の eCTD 申請において使用されるスキーマに関する要件:
Requirements for Japan eCTD Submission Package - XML Schema
10.
681
682
日本独自で規定するスキーマは無い。
683
There is no XML schema used only in Japan.
684
685
686
セキュリティ: Security
11.
•
ルも含めて、個々のファイルに対するチェックサムを含めること。
687
688
eCTD 申請には、eCTD XML メッセージインスタンスに対するチェックサムファイ
•
各 フ ァ イ ル の チ ェ ッ ク サ ム は 、 eCTD XML メ ッ セ ー ジ イ ン ス タ ン ス
689
（submissionunit.xml）中に該当 document 要素配下の integrity 要素の要素値として
690
記述する。
691
•
eCTD XML インスタンスについては、チェックサムをテキストファイルに記述し、
692
ファイル名を sha256.txt として submissionunit.xml と同じフォルダに格納する。ま
693
た、このチェックサム値を eCTD 用カバーレターに記載する。
694
•
媒体が審査当局に届くまでは申請者が媒体に対する全責任を負う。
695
•
申請者は eCTD の個別ファイルに対し、ファイルレベルのセキュリティ設定やパ
スワード保護を含めてはならない。
696
697
•
申請者は、審査当局に提出するファイルを圧縮（zip、lzh など）してはならない。
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•
698
699
The eCTD submission should contain checksums for each individual file including a
checksum file for the eCTD XML message instance.
•
700
SHA-256
checksum
value
of
each
file
should
be
provided
by
701
document.text.integrityCheck element of the simple document that references the file in
702
the eCTD XML message instance (submissionunit.xml).
•
703
A checksum of the XML eCTD message instance should also be included as text in a text
704
file (sha256.txt), which should be located in the same directory as the XML eCTD
705
message instance.
•
706
707
The applicant should assume all liability for the media until it is delivered to the regulatory
authority.
•
708
709
Applicants should not include any file level security settings or password protection for
individual files in the eCTD.
•
710
711
Applicants should not submit any compressed (zip, lzh, etc.) file to the regulatory
authority.
712
713
12.
714
12.1
ライフサイクル管理: Life cycle Management
概要: Lifecycle Overview
715
日本における eCTD のライフサイクル管理とは、個々の申請において、申請資料の追
716
加、変更等の管理を行うこととし、一製品における新規申請、一部変更申請等を一括し
717
て管理するものではないものとする。
718
つまり、個々の申請においては、eCTD 受付番号配下の提出連続番号（000001、000002
719
…）に従ったフォルダ（m1、m2、m3、m4、m5）に申請資料が格納される。申請資料を
720
構成するファイルについて、追加、変更、削除が行われた際に、申請資料としてどのフ
721
ァイルが有効であるかをファイル単位でその属性情報により管理することがライフサ
722
イクル管理の目的である。
723
eCTD v4.0 のライフサイクル管理においては、原則、差分提出方式を採用し、申請者
724
は 000002 以降の eCTD 提出において、新規あるいは変更された情報のみを提出する。但
725
し、情報の性質あるいは規格の仕様上、変更が無い情報も提出しなければならない場合
726
があることに留意すること。詳細は 12.3 参照のこと。
727
eCTD life cycle management in Japan is to manage the changes (addition, replacement,
728
removal, etc.) of the dossier, and is not to collectively manage a product’s transition through new
729
marketing approval application, partial change approval, and such.
730
In individual eCTD submission, the dossier is stored in the folders (i.e., m1, m2, m3. m4, and
731
m5) under the sequence number folder (e.g., 000001, 000002).
732
cycle management in Japan is to identify which file in the dossier is relevant for the review of
733
the submission by the information given by the message instance.
For Step2 For Testing
Page 43 of 126
The scope of the eCTD life
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734
The eCTD v4.0 in Japan takes the cumulative approach in principle, where only new or
735
modified information is submitted in sequence 000002 or higher.
Note that, by the nature or
736
technical definition, there are cases where some unchanged information need to be provided.
737
See 12.3 for details.
738
739
12.2
Sequence 000001
740
741
eCTD 初回提出時に関する要件: Requirements for Japan eCTD Submission -
12.2.1
初回提出時のフォルダ構造: Folder Structure
1) 提出するためのフォルダ構造 Structure to be submitted
742
743
本ガイドのセクション 6 を参照してフォルダ構造を作成する。但し、格納す
744
るファイルが無いフォルダは作成しない。
745
The folder structure for the initial submission should be prepared in reference to the
746
section 6 in this guide.
747
created.
However, the folder which has no file should not be
748
2) フォルダ命名規則: Folder Naming Convention
749
750
フォルダ命名規則は ICH IG 記載の通りとする。
751
The folder name convention defined in ICH IG applies to eCTD v4.0
752
implementation in Japan.
753
754
755
12.2.2
初回提出時のファイル: Document Files
1) 含めるべきファイル Files to be included
756
本ガイドのセクション 5.1 及びセクション 7 から 9 を参照して eCTD 申請時
757
に含めるべき構成物を作成する。
758
The components of the initial eCTD submission should be prepared in reference to
759
the section 5.1 and section 7 to 9 in this guide.
760
761
2) ファイル名: File Naming Convention
762
ファイル命名規則は、ICH IG に従うこととし、Module 5.3.7 については、本
763
ガイドのセクション 6.2 を参照すること。
764
File name convention defined in ICH IG applies to eCTD v4.0 implementation in
765
Japan. For Module 5.3.7, refer to the section 6.2 of this guide.
766
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12.2.3
初回提出時のインスタンス:eCTD XML Message Instance
768
基本構造については、ICH IG に従って eCTD XML メッセージインスタンスを作成す
769
る。このセクションでは日本固有のインスタンスの記載について述べる。16.2 の XML
770
サンプルメッセージインスタンスを参照のこと。
771
Basic structure of eCTD XML message instance should be created according to ICH IG. This
772
section describes Japan specific elements and attributes to be provided for JP eCTD submission
773
in addition to the basic structure.
Sample XML message instance is provided in Section 16.2.
774
1) submissionUnit 要素から categoryEvent 要素までの記載
775
XML snippet from submissionUnit to categoryEvent
776
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
<submissionUnit>
<id root="A" extension="B"/>
<code code="C" codeSystem="D"/>
<subject>
<categoryEvent>
<code code="E" codeSystem="F"/>
</categoryEvent>
</subject>
A: ICH IG に基づく当該 submissionUnit の固有識別子 Unique ID of this submissionUnit
based on ICH IG
B: eCTD 受付番号-シーケンス番号 eCTD Receipt Number-Sequence number
C: この submissionUnit が正式かドラフトかを示すコード Code for official or draft (see
"JP Submission Unit Code" on CV spreadsheet)
D: コントロールド・ボキャブラリ"JP Submission Unit Code"の OID OID of CV "JP
Submission Unit Code"
E: どの審査過程で提出されたかを示すコード Code for JP review step (see JP Category
Event” on CV spreadsheet)
F: コントロールド・ボキャブラリ"JP Category Event"の OID OID of "JP Category
Event"
796
2) contexOfUse 要素の記載
797
XML snippet for contextOfUse element
798
799
800
801
802
803
804
805
806
807
808
809
810
811
812
<component>
<priorityNumber value="G"/>
<contextOfUse>
<id root="H"/>
<code code="I" codeSystem="J"/>
<statusCode code="K"/>
<setId root="L"/>
<versionNumber value="M"/>
<derivedFrom>
<documentReference>
<id root="N"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
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813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
G: 同一 CTD 番号の CoU が複数存在する場合に、ICH IG に基づき表示順序を定める
値（複数存在しない場合も記述する）The display order of CoUs in case where multiple
CoUs of the same code exist (priorityNumber@value is always required when there is only
one CoU of the same code)
H: ICH IG に基づく本 Context Of Use の固有識別子 Unique ID of CoU defined in ICH IG
I: この CoU が指す document を割り当てる CTD 番号を示すコード（CV spreadsheet の
「ICH CoU (ToC) Codes」を参照のこと。） Code indicating CTD section to which the
referencing document is applied (see "JP Context of Use Code” of CV spreadsheet).
J: この CoU の code（上記 I）を定義するコードリストの OID OID of the code list that
defines the CoU code ("I” abovementioned)
K: ICH IG に基づく、この CoU のステータス Status of this CoU specified in ICH IG
L: 同一の位置付けで提出される CoU 群（セット）の固有識別子 identifier of a group
(set) of CoUs provided in the same context
M: セット内におけるその CoU のバージョン番号 Version number of the CoU in the set
N: 紐付けされる document の id@root id@root of the relative document
831
3) submission 要素の記載
832
XML snippet for submission
833
834
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850
851
852
853
854
855
856
857
858
859
860
861
862
863
<componentOf>
<sequenceNumber value="Q"/>
<submission>
<id>
<item root="R" extension="S"/>
</id>
<code code="T" codeSystem="U"/>
<subject2>
<review>
<id root="V" extension="W"/>
<effectiveTime value="X"/>
<statusCode code="Y"/>
<subject1>
<manufacturedProduct>
<manufacturedProduct>
<name xsi:type="DSET_EN">
<item>
<part value="Z"/>
</item>
</name>
<ingredient>
<activeIngredientSubstance>
<name>
<part value="AA"/>
</name>
</activeIngredientSubstance>
</ingredient>
</manufacturedProduct>
</manufacturedProduct>
</subject1>
<holder>
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864
865
866
867
868
869
870
871
872
873
874
875
876
877
878
879
880
881
882
883
884
885
886
887
888
889
890
891
892
893
894
895
896
897
898
899
900
901
902
903
904
905
906
907
<applicant>
<sponsorOrganization>
<name xsi:type="DSET_EN">
<item>
<part value="AB"/>
</item>
</name>
</sponsorOrganization>
</applicant>
</holder>
<subject2>
<productCategory>
<code code="AC" codeSystem="AD"/>
</productCategory>
</subject2>
</review>
</subject2>
</submission>
</componentOf>
Q: この submissionUnit のシーケンス番号（初回申請では 000001） Sequence number of
this submissionUnit (000001 for initial submission)
R: この Submission の固有識別子 Unique ID of this submission
S: eCTD 受付番号 eCTD Receipt Number
T: この submission が正本提出であるか参考提出であるかを示すコード（CV spreadsheet
の"JP Submission Code"を参照のこと） Code identifying whether this submission is
original or reference (see "JP Submission Code" of CV spreadsheet)
U: この Submission のコード（上記 T）を定義するコードリストの OID（コントロー
ルド・ボキャブラリ「JP Submission Code」の OID） OID of the code list that defines
the Submission code ("T" abovementioned) (OID of "JP Submission Code" of CV
spreadsheet)
V: review の固有識別子 Unique ID of each review
W: 日本における運用において定義する、申請書の固有識別子 Regionally-defined
unique ID of each application form.
X: 申請日（yyyymmdd：yyyy=西暦、mm=月、dd＝日） Submission date (yyyymmdd:
yyyy=year, mm=month, dd=day)
Y: その申請書のステータス（"active" あるいは"inactive"） Status of the application
form ("active" or "inactive")
Z: 販売名 product name
AA: 有効成分名 active ingredient name
AB: 申請者名 applicant name
AC: 申請区分を示すコード（CV spreadsheet の"JP Product Category Code"を参照のこと）
Code identifying the product category (see "JP Product Category Code" of CV spreadsheet)
AD: Product Category コード（上記"AC"）を定義するコードリストの OID （コントロ
ールド・ボキャブラリ「JP Product Category Code」の OID）
908
909
910
5) application 要素から application reference 要素までの記載
911
XML snippet from application to application reference
912
<componentOf>
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913
914
915
916
917
918
919
920
921
922
923
924
925
926
927
928
929
930
931
932
933
934
935
936
937
938
939
940
941
942
943
944
945
<application>
<id>
<item root="AE" extension="AF"/>
</id>
<code code="AG" codeSystem="AH"/>
<reference>
<applicationReference>
<id root="AI"/>
<reasonCode>
<item code="AJ" codeSystem="AS"/>
</reasonCode>
</applicationReference>
</reference>
AE: この Application の固有識別子 Unique identifier of this Application
AF: eCTD 受付番号 eCTD Receipt Number
AG: この Application が製造販売承認申請であることを示すコード（CV spreadsheet の
"JP Application Code"を参照のこと） Code identifying that this application is for
marketing approval (see "JP Application Code" of CV spreadsheet)
AH: この Application のコード（上記"AG"）を定義するコードリストの OID（コント
ロールド・ボキャブラリ「JP Application Code」の OID） OID of the code list that
defines the Application code ("AG" abovementioned) (OID of "JP Application Code" of
CV spreadsheet)
AI: この Application と関連（一変等）する Application の id@root の値 id@root of the
application related to (partial change, etc.) this application
AJ: 関連の種類を示すコード（CV spreadsheet の「JP Application Reference Reason」を
参照のこと） Code identifying the type of relationship (see "JP Application Reference
Reason" code of CV spreadsheet)
AK: この関連の種類のコード（上記"AJ"）を定義するコードリストの OID（コントロ
ールド・ボキャブラリ「JP Application Reference Reason」の OID） OID of the code
list that defines the reason code ("AJ" abovementioned) (OID of "JP Application Reference
Reason" of CV spreadsheet)
12.2.4
946
特に複雑なケースの記載例: Instructions for Complex Cases
To be added
947
948
949
12.3
000002 and Higher
950
951
952
eCTD 改訂時に関する要件: Requirements for Japan eCTD Submission – Sequence
12.3.1
改訂時のフォルダ構造: Folder Structure
1) 提出するためのフォルダ構造: Structure to be submitted
953
改訂時（000002 以降）は、下記のフォルダのみを ICH IG 規定のフォルダ構
954
造に合わせて提出する。ドキュメントあるいはファイルの再利用によって格
955
納するファイルが存在しない場合は、該当する CTD 番号のフォルダは作成
956
しないこと。
957
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第 2 階層フォルダ（シーケンス番号をフォルダ名とするフォルダ）
959
その改訂により提出するファイルが格納されているフォルダ及びそ
の上位フォルダ
960
961
In revision of eCTD (when submitting a submission unit with sequence number
962
000002 or higher), only the following folders should be provided in accordance
963
with the structure defined by ICH IG.
964
submitted in that submission unit because of reusing document or file, the folder for
965
that CTD section should not be submitted.
In the cases where there is no file to be
966
Top level folder
967
Second-level folder (the folder which has the sequence number as its folder
968
name)
969
970
The folder which contains the files provided in that submissionUnit and its
superordinate folder
971
2) フォルダ命名規則: Folder Naming Convention
972
973
フォルダ命名規則は ICH IG 記載の通りとする。
974
The folder name convention defined in ICH IG applies to eCTD v4.0
975
implementation in Japan.
976
977
978
979
12.3.2
改訂時のファイル: Document Files
1) 含めるべきファイル: Files to be included
下記のファイルが提出される。
980
カバーレター
981
eCTD XML メッセージインスタンス (submissionUnit.xml)
982
sha256.txt
983
その submission unit で追加されるファイル
984
The following files should be included in the submission unit with sequence
985
number 000002 or higher.
986
Cover Letter
987
eCTD XML Message Instance (submissionUnit.xml)
988
sha256.txt
989
Files added in that submission unit
990
991
992
2) ファイル名: File Naming Convention
ファイル命名規則は、ICH IG に従うこととする。
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993
File name convention defined in ICH IG applies to eCTD v4.0 implementation in
994
Japan
995
996
997
12.3.3
改訂時の XML メッセージインスタンス: XML Message Instance
998
基本構造については、ICH IG に従って eCTD XML メッセージインスタンスを作成す
999
る。このセクションでは日本固有のインスタンスの記載について述べる。16.2 の XML
1000
サンプルメッセージインスタンスを参照のこと。Basic structure of eCTD XML message
1001
instance should be created according to ICH IG. This section describes Japan specific elements
1002
and attributes to be provided for JP eCTD submission in addition to the basic structure.
1003
XML message instance is provided in Section 16.2.
Sample
1004
1005
1006
12.3.3.1
applicant
When any applicant information is updated through life cycle, the review element and all its
1007
subordinate elements and attributes are provided, including unchanged elements and attributes.
1008
How to provide applicant information in sequence 000002 or later is the same as the way in the
1009
initial submission.
1010
1011
1012
1013
See 9.3.1 for details.
12.3.3.2
application
Refer to ICH IG for basic rules for handling application and its relative elements and attributes
in life cycle. The followings are Japan specific rules for changes through life cycle.
1014
application.id.item@extension value does not change
1015
application.code@code value is not allowed to be changed
1016
application.code@codeSystem value is not allowed to be changed
1017
1018
1019
12.3.3.3
applicationReference
When any applicationReference information is updated through life cycle, all
1020
applicationReference elements and its subordinate elements and attributes are provided,
1021
including unchanged elements and attributes.
1022
information in sequence 000002 or later is the same as the way in the initial submission.
1023
9.3.3 for details.
How to provide applicationReference
See
1024
1025
1026
12.3.3.4
categoryEvent
By the nature of the information provided by categoryEvent, there is no concept of update it.
1027
Rather, categoryEvent is the one that needs to be provided in every sequence with a new value.
1028
How to provide categoryEvent information in sequence 000002 or later is the same as the way in
1029
the initial submission.
See 9.3.4 for details.
1030
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1032
1033
12.3.3.5
contextOfUse
Refer to ICH IG for basic rules for handling contextOfUse and its relative elements and
attributes in life cycle. The followings are Japan specific rules for changes through life cycle.
1034
Reactivation of contextOfUse is not allowed
1035
contextOfUse.code@code value is not allowed to be changed
1036
contextOfUse.code@codeSystem value is not allowed to be changed
1037
Replacement of contextOfUse can be conducted only when there is a clear
1038
relationship between the document referenced by the replacing contextOfUse and the
1039
document referenced by the contextOfUse being replaced.
1040
relationship between the two, the old contextOfUse should be removed and a new
1041
contextOfUse referencing a new document should be provided with the same
1042
contextOfUse code.
1043
1044
1045
1046
When there is no
12.3.3.6
document
Refer to ICH IG for basic rules for handling document and its relative elements and attributes
in life cycle. The followings are Japan specific rules for changes through life cycle.
1047
document.code@code value is not allowed to be changed
1048
document.code@codeSystem value is not allowed to be changed
1049
Replacement of compound document with simple document is not allowed.
1050
Replacement of simple document with compound document is not allowed.
1051
1052
1053
12.3.3.7
documentReference
Refer to ICH IG for basic rules for handling documentReference and its relative elements and
1054
attributes in life cycle.
1055
later is the same as the way in the initial submission. See 9.3.7 for details.
1056
1057
1058
12.3.3.8
ingredient
When any ingredient information is updated through life cycle, the review element and all its
How to provide documentReference information in sequence 000002 or
1059
subordinate elements and attributes are provided, including unchanged elements and attributes.
1060
How to provide ingredient information in sequence 000002 or later is the same as the way in the
1061
initial submission.
1062
1063
1064
1065
See 9.3.8 for details.
12.3.3.9
keyword
Refer to ICH IG for the rules for handling keyword and its relative elements and attributes in
life cycle.
1066
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1067
1068
1069
12.3.3.10 keywordDefinition
Refer to ICH IG for the rules for handling keywordDefinition and its relative elements and
attributes in life cycle.
1070
1071
1072
12.3.3.11 manufacturedProduct
When any manufacturedProduct information is updated through life cycle, the review
1073
element and all its subordinate elements and attributes are provided, including unchanged
1074
elements and attributes.
1075
000002 or later is the same as the way in the initial submission.
1076
1077
1078
1079
1080
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
How to provide manufacturedProduct information in sequence
See 9.3.11 for details.
12.3.3.12 previousKeywordDefinition
Refer to ICH IG for the rules for handling previousKeywordDefinition and its relative
elements and attributes in life cycle.
12.3.3.13 priorityNumber.contextOfUse
Refer to ICH IG for the rules for handling priorityNumber.contextOfUse and its relative
elements and attributes in life cycle.
12.3.3.14 priorityNumber.document
Refer to ICH IG for the rules for handling priorityNumber.document and its relative elements
and attributes in life cycle.
12.3.3.15 productCategory
When any productCategory information is updated through life cycle, the review element and
1091
all its subordinate elements and attributes are provided, including unchanged elements and
1092
attributes.
1093
same as the way in the initial submission. See 9.3.15 for details.
1094
1095
1096
1097
1098
1099
1100
How to provide productCategory information in sequence 000002 or later is the
12.3.3.16 relatedContextOfUse
Refer to ICH IG for the rules for handling relatedContextOfUse and its relative elements and
attributes in life cycle.
12.3.3.17 review
When any information given by review or its subordinates is updated through life cycle, the
1101
review and all its subordinate elements and attributes are provided, including unchanged
1102
elements and attributes.
1103
cycle.
1104
submission. See 9.3.17 for details.
The review.id@root value should stay the same through the entire life
How to provide review in sequence 000002 or later is the same as the way in the initial
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When there is no change in any information given by
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1105
review or its subordinate, the superordinate subject2 element (and therefore review element)
1106
should not be provided.
1107
When adding a new Application Form to associate it to the previously submitted eCTD
1108
submission, a new review with a new ID should be provided. In such case, all the reviews
1109
including those with no change should be provided along with all the subordinate elements and
1110
attributes in the same submission unit.
1111
should be added to the previously submitted eCTD or provided as a part of new eCTD.
Consult PMDA as to whether the new Application Form
1112
When there are multiple Application Forms associated to the eCTD submission and one or
1113
more (but not all) Application Forms are being withdrawn, provide the review element with the
1114
review.id@root value of the withdrawing Application Form and review.statusCode@code with a
1115
value of “inactive”.
1116
message instance does not need to be provided in addition to the Application for Withdrawal
1117
when withdrawing all the Application Form(s) associated to the eCTD submission.
1118
1119
1120
1121
1122
1123
1124
1125
In such case, no other information is needed to be provided. Note that the
12.3.3.18 sequenceNumber.submission
Refer to ICH IG for the rules for handling keywordDefinition and its relative elements and
attributes in life cycle.
12.3.3.19 submission
The submission is always provided in every sequence. The following information should
stay the same through the entire life cycle of the submission.
1126
submission.id.item@root
1127
submission.id.item@extension
1128
submission.code@code
1129
submission.code@codeSystem
1130
1131
1132
1133
1134
1135
How to provide submission information in sequence 000002 or later is the same as the way in
the initial submission.
See 9.3.19 for details.
12.3.3.20 submissionUnit
Refer to ICH IG for basic rules for handling submissionUnit and its relative elements and
attributes in life cycle. The followings are Japan specific rules for changes through life cycle.
1136
submissionUnit.id@extension value is different in every sequence
1137
submission.code@code value should stay the same through the entire life cycle of
1138
1139
1140
submission
submission.code@codeSystem value should stay the same through the entire life
cycle of submission
1141
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1142
13.
コントロールド・ボキャブラリ: Controlled Vocabularies
1143
コントロールド・ボキャブラリは 16.5 を参照のこと
1144
For Controlled Vocabularies, refer to 16.5 in this guide.
1145
1146
14.
問い合わせ先: Contacts
1147
eCTD v4.0 の運用に関する質問等は、下記にて受け付ける。また、一般的事項につい
1148
ては、一企業のみに対して回答することは望ましくないため、業界全体に回答が普及す
1149
るよう、JPMA 等業界団体を通して提出すること。特定の品目についての質問について
1150
はこの限りではない。
1151
[email protected]
1152
Contact information for eCTD v4.0 implementation in Japan is as follows:
1153
[email protected]
1154
In principle, only the question from those actually submitting eCTD to PMDA is acceptable.
1155
Note that general question should not be submitted by individual company but should be
1156
submitted through JPMA. Any question relevant to specific eCTD submission can be
1157
submitted by the applicant themselves.
1158
1159
15.
参考文献
1160
参考文献を以下に示す。
1161
References are following.
(TBD)
1162
1163
1164
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別添: Appendices
1165
16.
1166
16.1
1167
16.1.1
1168
M1 の作成要領: Specification for Module 1
目的: Purpose
Module 1 を電子的に作成する場合の仕様を示したものである。
1169
1170
1171
1172
1173
1174
1175
16.1.2
フォルダ構成並びにフォルダ命名規則: Folder structure and naming convention
第 1 部のフォルダ構成及びフォルダの命名は原則以下のフォルダ構成とする。必要に
応じて申請者は JP フォルダ以下にフォルダを作成しても良い。
Folder stricture and name are shown as following. If necessary, it is allowed to create new
folder in JP folder.
M1/JP
1176
1177
1178
1179
1180
1181
1182
16.1.3
第 1 部のファイル命名について: File name
第一部のファイルは、以下のファイル名を参考に設定すること。ただし、カバーレタ
ーのファイル名は必ず cover.pdf とすること。
Files in module 1 could be named according to following list. File name of cover letter must
be cover.pdf.
参考までに第 1 部用ファイルの名称を記載する。Please refer to following list:
Title
Cover Letter
1.1-1 Table of contents for approval applications including Part I
1.1-2 Summary table
1.2 Approval application (copy)
1.3-1 Certificates (Declarations of those responsible for collection and
compilation of data for approval applications, GLP and GCP
related data)
1.3-2 Declarations of those responsible for scanning of paper document.
1.4 Information on patent matters
1.5 Data concerning the origin background of discovery and the
background of development
1.6 Information on the use of the drug in foreign countries, etc.
1.7 List of similar products from the same therapeutic category with the
same efficacy
1.8 (Proposed) package insert
1.9 Documents pertaining to the non-proprietary name of the drug
1.10 Summary of data pertaining to the designation as poisonous drug,
powerful drug, etc.
1.11 Master plan for post-marketing surveillance (PMS), etc. (daft)
1.12-1 List of attached data (PDF)
1.12-2 List of attached data (MS Excel)
1.13-1-1 Approval certificate (copy)
1.13-1-2 Review report
1.13-1-3 Data corresponding to Part II (CTD summaries)
1.13-1-4 List of attached data
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Page 55 of 126
File Name
cover.pdf
m1-01-01.pdf
m1-01-02.pdf
m1-02-XX.pdf
m1-03-01.pdf
m1-03-02.pdf
m1-04-01.pdf
m1-05-01.pdf
m1-06-01.pdf
m1-07-01.pdf
m1-08-01.pdf
m1-09-01.pdf
m1-10-01.pdf
m1-11-01.pdf
m1-12-01.pdf
m1-12-02.xls(x)
m1-13-01-01.pdf
m1-13-01-02.pdf
m1-13-01-03.pdf
m1-13-01-04.pdf
Ver:0.11
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Title
1.13-2 Records of clinical trial consultation (copies)
1.13-3 Inquiries (copies) and responses to the inquiries (copies)
1.13-4-1-1-1 List of data concerning the new excipient
1.13-4-1-1-2 List of each substance under review
1.13-4-1-1-3 Copy of the approval of a product containing the excipient
1.13-4-1-1-4 Summary of the new excipient
1.13-4-1-1-XX Data concerning the new excipient
1.13-4-1-2 List of the main manufacturing process parameters not
mentioned in the approval application
File Name
m1-13-02-XX.pdf
m1-13-03-XX.pdf
m1-13-04-01-01-01.pdf
m1-13-04-01-01-02.pdf
m1-13-04-01-01-03.pdf
m1-13-04-01-01-04.pdf
m1-13-04-01-01-XX.pdf
m1-13-04-01-02.pdf
1183
1184
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1185
16.1.4 V3.2.2 との比較 : Mapping between eCTD v3.2.2 jp-regional-index.xml and regional portions of eCTD v4.0 XML Message Instance
#
v3.2.2 jp-regional-index.xml
v4.0
XML Message Comment
Referencia
Instance
l Section
Element
Attribute Description / Instruction
Value
/ XPATH
Example
1
universal
The top-level tag that organizes all of the
NA
Not
submission
information
called
applicable in
“top-element”.
JP
eCTD
v4.0.
2
Lang
The specification of the language used in ja
/@encoding
9.1
the instance. Fixed value of "ja"
3
schema- XML schema version
1.0
/PORP_IN000001UV/@ The value of
version
xsi:schemaLocation
the
schemaLocati
on attributes
tells
the
version.
4
xsi:sche XML schema location
universal../.. /PORP_IN000001UV/@
ma-locat
/util/dtd/jp-r xsi:schemaLocation
ion
egional-1-0.
xsd
5
universal/documentThe tag that describes the identification
NA
Not
identifier
data of the document called "element"
applicable in
JP
eCTD
v4.0.
Not
6
universal/documentApplicant
should
describe
the 申請書等行 NA
applicable in
identifier/title
explanation for <doc-id> or the title. In 政情報及び
JP
eCTD
module 1, it is fixed as "申請書等行政 添付文書に
v4.0.
情報及び添付文書に関する情報".
関する情報
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#
v3.2.2 jp-regional-index.xml
Element
7
universal/documentidentifier/doc-id
8
universal/document
9
universal/document/
content-block
10
Attribute
Description / Instruction
Applicant should insert the information
such as the document identification
number. In module 1, it consists of the
following number:"eCTD Application
number" followed by "-" and
"Submission Number".
A container element that represents the
document body.
admin, m1
管理情報
universal/document/
content-block/blocktitle
Applicant
should
describe
the
explanation of the category specified in
the content-block, or the title.
12
universal/document/
content-block/doc-c
ontent
The element to specify the content
description and the document file.
Applicant should duplicate this element
to describe more information.
Page 58 of 126
Comment
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/id/@exten
sion
NA
Applicant
should
describe
the
information to specify the category in
the column above. See the sample
instance for module 1.
11
Message
NA
A container element to organize and
categorize the information.
param
For Step2 For Testing
Value
/
Example
2107070010001
v4.0
XML
Instance
XPATH
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
t/contextOfUse/code/@co
de
NA
NA
Ver:0.11
Referencia
l Section
9.3.20
Not
applicable in
JP
eCTD
v4.0.
Not
applicable in
JP
eCTD
v4.0.
9.3.5
Not
applicable in
JP
eCTD
v4.0.
Not
applicable in
JP
eCTD
v4.0.
CONFIDENTIAL
#
v3.2.2 jp-regional-index.xml
Element
Attribute
Description / Instruction
13
xlink:typ
e
Specify the type “simple” of a link. This
attribute value is fixed so that an
attribute description can be omitted.
14
xlink:hre
f
"Indicate the location of a document file
with a relative path.
../../../23120
5001/0000/
m1/jp/m1-0
1-01.pdf
15
param
Provide information for identifying the
specified content description/file. For
descriptions in Module 1, see the sample
instance.
01
For Step2 For Testing
Page 59 of 126
Value
Example
simple
/
v4.0
XML
Instance
XPATH
Message
NA
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/compone
ntOf/application/compon
ent/document/text/referen
ce/@value
NA
Ver:0.11
Comment
Referencia
l Section
Not
applicable in
JP
eCTD
v4.0.
9.3.6
Not
applicable in
JP eCTD v4.0
CONFIDENTIAL
#
v3.2.2 jp-regional-index.xml
Element
16
Attribute
universal/document/
content-block/doc-c
ontent/property
17
For Step2 For Testing
name
Description / Instruction
Applicant should describe the property
information specified in the doc-content
following the description:
In the administrative information
section,
applicant
specifies
the
information type as the name attribute
and describes the content.
To describe more than one of
administrative information, the applicant
assigns “sequencenumber” to the name
attribute and describe the repetitive
identification number.
In the TOC section, the applicant assigns
“operation”,
“checksum”,
and
“checksum-type” to the name attribute,
and describe corresponding content in
accordance with eCTD specification.
When referring to multiple files, the
applicant assigns “sequencenumber” to
the name attribute and describe the
repetitive identification number.
Applicant should describe the property
category.
When modifying, the applicant assigns
“modified” to the name attribute, and
describe the modified file information in
accordance with eCTD specification in
addition to the name attribute mentioned
above.
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Value
/
Example
Vary.
See
#19-#26
Vary.
See
#19-#26
v4.0
XML
Instance
XPATH
Message
Vary.
See #19-#26
Vary.
See #19-#26
Ver:0.11
Comment
Vary.
#19-#26
Referencia
l Section
See
CONFIDENTIAL
#
v3.2.2 jp-regional-index.xml
Element
18
19
<property
name="submissionnumber"
info-type="jp-region
al-m1-admin">
20
<property
name="brand-name"
info-type="jp-region
al-m1-admin">
21
<property
name="sequencenu
mber"
info-type="jp-region
al-m1-admin">
For Step2 For Testing
Attribute
Description / Instruction
Info-typ
e
Applicant should describe the property
type.
Applicant
enters ”jp-regional-m1-admin” in the
administrative information section, and
“jp-regional-m1-toc” in the TOC section.
eCTD Receipt Number (eCTD 受付番
号)
Value
/
Example
Vary.
See
#19-#26
v4.0
XML
Instance
XPATH
Vary.
Message
See #19-#26
Vary.
Referencia
l Section
See
#19-#26
210707001
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/id/item/@
extension
Product Name (販売名):
Name of product.
セイヤクキ
ョ ー ル
20mg 錠
Order of information; for example, if
multiple product information are
provided, applicant can apply the order
of the products to be presented.
01
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/subject2/r
eview/subject1/manufact
uredProduct/manufacture
dProduct/name/item/part/
@value
NA
Page 61 of 126
Comment
Ver:0.11
The
eCTD
Receipt
Number
is
given
as
regional IDs
of application
and
submission.
Japanese
characters
needs to be
allowed.
Not
applicable in
JP eCTD v4.0
9.3.2
9.3.19
9.3.11
CONFIDENTIAL
#
v3.2.2 jp-regional-index.xml
Element
Attribute
Description / Instruction
Value
/
Example
イーアイ塩
酸塩
22
<property
name="generic-nam
e"
info-type="jp-region
al-m1-admin">
Name of Active Ingredient (一般名)
23
<property
name="applicant"
info-type="jp-region
al-m1-admin">
Applicant Name (申請者名):
日本製薬工
業
24
<property
name="submissiondate"
info-type="jp-region
al-m1-admin">
Date of submitting Application Form(申
請日):
2009-07-17
25
<property
name="submission-t
ype"
info-type="jp-region
al-m1-admin">
Product Category (申請区分):
1-(4)：新効
能医薬品
For Step2 For Testing
Page 62 of 126
v4.0
XML
Instance
XPATH
Message
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/subject2/r
eview/subject1/manufact
uredProduct/manufacture
dProduct/ingredient/activ
eIngredientSubstance/na
me/part/@value
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/subject2/r
eview/holder/applicant/sp
onsorOrganization/name/i
tem/part/@value
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/subject2/r
eview/effectiveTime/@va
lue
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/subject2/r
eview/subject2/productCa
tegory/code/@code
Ver:0.11
Comment
Referencia
l Section
Needs to be
in JAN, not
INN.
9.3.8
Japanese
characters
needs to be
allowed.
9.3.1
9.3.17
9.3.15
CONFIDENTIAL
#
v3.2.2 jp-regional-index.xml
Element
26
<property
name="sequencenu
mber"
info-type="jp-region
al-m1-toc">
Attribute
Description / Instruction
Order of documents; for example, if
multiple documents are provided to a
single section, applicant can apply the
order of the documents within the
section.
Value
Example
02
/
v4.0
XML
Instance
XPATH
Message
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
t/priorityNumber/@value
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
t/priorityNumber/@value
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
t/priorityNumber/@value
OR
/PORP_IN000001UV/co
ntrolActProcess/subject/s
ubmissionUnit/componen
tOf/submission/compone
ntOf/application/compon
ent/document/component/
priorityNumber/@value
or
1186
For Step2 For Testing
Page 63 of 126
Ver:0.11
Comment
Referencia
l Section
The XPATHs
are for the
CoUs
with
the same code
and
compound
documents,
respectively.
9.3.13
9.3.14
CONFIDENTIAL
1187
16.2
XML サンプルインスタンス: Sample XML Massage Instance
1188
1189
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1234
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1239
16.2.1.1
初回提出時
<?xml version="1.0" encoding="UTF-8"?>
<PORP_IN000001UV xmlns="urn:hl7-org:v3" xmlns:mif="urn:hl7-org:v3/mif" xmlns:xsi="ht
tp://www.w3.org/2001/XMLSchema-instance" ITSVersion="XML_1.0" xsi:schemaLocation="
urn:hl7-org:v3 ../../schema/PORP_IN000001UV.xsd">
<id/>
<creationTime/>
<interactionId/>
<processingCode/>
<processingModeCode/>
<acceptAckCode/>
<receiver typeCode="RCV">
<device classCode="DEV" determinerCode="INSTANCE">
<id/>
</device>
</receiver>
<sender typeCode="SND">
<device classCode="DEV" determinerCode="INSTANCE">
<id/>
</device>
</sender>
<controlActProcess classCode="ACTN" moodCode="EVN">
<subject typeCode="SUBJ">
<submissionUnit>
<id root="1234.1234.1234.12345.0000" extension="231205001-0000"/>
<code code="JP-Official" codeSystem="jp-submission-unit"/>
<subject>
<categoryEvent>
<code code="JP-First" codeSystem="jp-category-event"/>
</categoryEvent>
</subject>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000001"/>
<code code="JP-m1.01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000001"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000001"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="2.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000002"/>
<code code="JP-m1.01" codeSystem="jp-context-of-use"/>
For Step2 For Testing
Page 64 of 126
Ver:0.11
CONFIDENTIAL
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<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000002"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000002"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000003"/>
<code code="JP-m1.02" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000003"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000003"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="2.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000004"/>
<code code="JP-m1.02" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000004"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000004"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000005"/>
<code code="JP-m1.03" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000005"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000005"/>
</documentReference>
</derivedFrom>
</contextOfUse>
For Step2 For Testing
Page 65 of 126
Ver:0.11
CONFIDENTIAL
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</component>
<component>
<priorityNumber value="2.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000006"/>
<code code="JP-m1.03" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000006"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000006"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000007"/>
<code code="JP-m1.04" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000007"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000007"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000008"/>
<code code="JP-m1.05" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000008"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000008"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000009"/>
<code code="JP-m1.06" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000009"/>
<versionNumber value="1"/>
For Step2 For Testing
Page 66 of 126
Ver:0.11
CONFIDENTIAL
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1401
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000009"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000010"/>
<code code="JP-m1.07" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000010"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000010"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000011"/>
<code code="JP-m1.08" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000011"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000011"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000012"/>
<code code="JP-m1.09" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000012"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000012"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
For Step2 For Testing
Page 67 of 126
Ver:0.11
CONFIDENTIAL
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<contextOfUse>
<id root="0.123.456.230525001.0812.0000013"/>
<code code="JP-m1.10" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000013"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000013"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000014"/>
<code code="JP-m1.11" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000014"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000014"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000015"/>
<code code="JP-m1.12" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000015"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000015"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="2.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000016"/>
<code code="JP-m1.12" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000016"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000016"/>
For Step2 For Testing
Page 68 of 126
Ver:0.11
CONFIDENTIAL
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1509
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000017"/>
<code code="JP-m1.13-02" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000017"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000017"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000018"/>
<code code="JP-m1.13-04-01-01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000018"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000018"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="2.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000019"/>
<code code="JP-m1.13-04-01-01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000019"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000019"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="3.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000020"/>
<code code="JP-m1.13-04-01-01" codeSystem="jp-context-of-use"/>
For Step2 For Testing
Page 69 of 126
Ver:0.11
CONFIDENTIAL
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<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000020"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000020"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="4.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000021"/>
<code code="JP-m1.13-04-01-01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000021"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000021"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="5.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000022"/>
<code code="JP-m1.13-04-01-01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000022"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000022"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="6.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000023"/>
<code code="JP-m1.13-04-01-01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000023"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000023"/>
</documentReference>
</derivedFrom>
</contextOfUse>
For Step2 For Testing
Page 70 of 126
Ver:0.11
CONFIDENTIAL
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</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000024"/>
<code code="JP-m1.13-04-01" codeSystem="jp-context-of-use"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000024"/>
<versionNumber value="1"/>
<derivedFrom>
<documentReference>
<id root="0.321.456.230525001.0812.0000024"/>
</documentReference>
</derivedFrom>
</contextOfUse>
</component>
<component>
<priorityNumber value="1.00"/>
<contextOfUse>
<id root="0.123.456.230525001.0812.0000025"/>
<code code="ICH-2-2" codeSystem="ich-cou"/>
<statusCode code="active"/>
<setId root="0.123.654.230525001.0812.0000025"/>
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For Step2 For Testing
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CONFIDENTIAL
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4100
4101
4102
4103
4104
4105
4106
4107
4108
4109
4110
4111
4112
4113
4114
4115
4116
4117
4118
4119
4120
4121
4122
<item code="MANU001" codeSystem="0.123.456.230525
001.1209.10003">
<displayName value="JPMA Pharmaceuticals Tokyo"/
>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-product" codeSystem="ich-cou-keyword-d
efinition-type"/>
<statusCode code="active"/>
<value>
<item code="PROD001" codeSystem="0.123.456.230525
001.1209.10004">
<displayName value="Seiyakukyol Tablet 10mg"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-product" codeSystem="ich-cou-keyword-d
efinition-type"/>
<statusCode code="active"/>
<value>
<item code="PROD002" codeSystem="0.123.456.230525
001.1209.10004">
<displayName value="Seiyakukyol Tablet 20mg"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-dosageform" codeSystem="ich-cou-keywor
d-definition-type"/>
<statusCode code="active"/>
<value>
<item code="DOSA001" codeSystem="0.123.456.230525
001.1209.10005">
<displayName value="Tablet 10mg"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-dosageform" codeSystem="ich-cou-keywor
d-definition-type"/>
<statusCode code="active"/>
<value>
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4123
4124
4125
4126
4127
4128
4129
4130
4131
4132
4133
4134
4135
4136
4137
4138
4139
4140
4141
4142
4143
4144
4145
4146
4147
4148
4149
4150
4151
4152
4153
4154
4155
4156
4157
4158
4159
4160
4161
4162
4163
4164
4165
4166
4167
4168
4169
4170
4171
4172
4173
4174
4175
4176
<item code="DOSA002" codeSystem="0.123.456.230525
001.1209.10005">
<displayName value="Tablet 20mg"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-excipient" codeSystem="ich-cou-keyworddefinition-type"/>
<statusCode code="active"/>
<value>
<item code="EXCI001" codeSystem="0.123.456.2305250
01.1209.10006">
<displayName value="compendial-excipient"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-excipient" codeSystem="ich-cou-keyworddefinition-type"/>
<statusCode code="active"/>
<value>
<item code="EXCI002" codeSystem="0.123.456.2305250
01.1209.10006">
<displayName value="hydroxyethylmethylcellulose"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-excipient" codeSystem="ich-cou-keyworddefinition-type"/>
<statusCode code="active"/>
<value>
<item code="EXCI003" codeSystem="0.123.456.2305250
01.1209.10006">
<displayName value="amylopectin"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-study-id" codeSystem="ich-document-key
word-definition-types"/>
<statusCode code="active"/>
<value>
<item code="id0000001" codeSystem="0.123.456.230525
001.1209.10007">
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4177
4178
4179
4180
4181
4182
4183
4184
4185
4186
4187
4188
4189
4190
4191
4192
4193
4194
4195
4196
4197
4198
4199
4200
4201
4202
4203
4204
4205
4206
4207
4208
4209
4210
4211
4212
4213
4214
4215
4216
4217
4218
4219
4220
4221
4222
4223
4224
4225
4226
4227
4228
4229
4230
<displayName value="NSK-N-001"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-study-id" codeSystem="ich-document-key
word-definition-types"/>
<statusCode code="active"/>
<value>
<item code="id0000002" codeSystem="0.123.456.230525
001.1209.10008">
<displayName value="NSK-C-001"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-study-id" codeSystem="ich-document-key
word-definition-types"/>
<statusCode code="active"/>
<value>
<item code="id0000003" codeSystem="0.123.456.230525
001.1209.10008">
<displayName value="NSK-C-017"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-study-id" codeSystem="ich-document-key
word-definition-types"/>
<statusCode code="active"/>
<value>
<item code="id0000004" codeSystem="0.123.456.230525
001.1209.10008">
<displayName value="NSK-C-018"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-study-id" codeSystem="ich-document-key
word-definition-types"/>
<statusCode code="active"/>
<value>
<item code="id0000005" codeSystem="0.123.456.230525
001.1209.10008">
<displayName value="NSK-C-015"/>
</item>
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4231
4232
4233
4234
4235
4236
4237
4238
4239
4240
4241
4242
4243
4244
4245
4246
4247
4248
4249
4250
4251
4252
4253
4254
4255
4256
4257
</value>
</keywordDefinition>
</referencedBy>
<referencedBy>
<keywordDefinition>
<code code="ICH-study-id" codeSystem="ich-document-key
word-definition-types"/>
<statusCode code="active"/>
<value>
<item code="id0000006" codeSystem="0.123.456.230525
001.1209.10008">
<displayName value="NSK-C-016"/>
</item>
</value>
</keywordDefinition>
</referencedBy>
</application>
</componentOf>
</submission>
</componentOf>
</submissionUnit>
</subject>
</controlActProcess>
</PORP_IN000001UV>
カバーレター様式: Form - Cover Letter
16.3
4258
To be added.
4259
4260
日本向け eCTD v4.0 XML Message Instance の基本構造: Basic Structure of JP
16.4
eCTD v4.0 XML Message Instance
4261
4262
4263
4264
4265
4266
ICH IG で定義されている基本構造を下に記す。このうち、グレーで示されている要素
/属性は日本では使用しない:
The following table shows the basic structure of ICH eCTD v4.0 XML Message Instance
based on the ICH IG.
The grayed out Elements / Attributes are not used in Japan:
4267
Elements
submissionUnit
id
Attribute
root
extension
code
code
codeSystem
title
statusCode
callBackContact
subject
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Elements
categoryEvent
code
Attribute
code
codeSystem
subject
component
priorityNumber
value
contextOfUse
id
root
extension
code
code
codeSystem
title
statusCode
code
setId
root
versionNumber
value
primaryInformationRecipient
links
sequelTo
typeCode
relatedContextOfUse
id
root
versionNumber
derivedFrom
documentReference
id
root
subjectOf
referencedBy
keyword
code
code
codeSystem
statusCode
componentOf
sequenceNumber
value
submission
id
item
root
extension
code
code
codeSystem
callBackContact
subject2
review
id
root
statusCode
code
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Elements
Attribute
updateMode
effectiveTime
value
subject1
dedicatedServiceDeliveryLocation
manufacturedProduct
id
manufacturedProduct
name
xsi:type
item
part
value
asNamedEntity
ingredient
activeIngredientSubstance
name
part
value
holder
applicant
sponsorOrganization
id
name
xsi:type
item
part
value
telecom
addr
author
subject2
productCategory
code
code
codeSystem
subject1
subject3
subject4
subject5
componentOf
application
id
item
root
extension
code
code
codeSystem
holder
informationRecipient
subject
reference
applicationReference
id
root
reasonCode
item
code
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Elements
Attribute
codeSystem
component
document
id
root
code
code
codeSystem
title
value
updateMode
text
integrityCheckAlgorithm
reference
value
integrityCheck
setID
root
versionNumber
value
sequelTo
component
priorityNumber
value
document
id
root
code
title
text
setId
versionNumber
sequelTo
component
referencedBy
keyword
code
code
codeSystem
referencedBy
keywordDefinition
code
code
codeSystem
statusCode
value
item
code
codeSystem
displayName
value
replacementOf
previousKeywordDefinition
code
code
codeSystem
value
item
code
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Elements
Attribute
codeSystem
reviewableUnit
4268
4269
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4270
16.5
4271
コントロールド・ボキャブラリ: Controlled Vocabularies
To be added.
4272
4273
4274
16.6
Validation Criteria
To be added or separated from this IG.
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