Index Special Licensing System Before Approval .... 45 1 Transfer of Approvals ..................................... 49 15-Day reports (ADR) ............................... 107, 159 Approval And Licenses Drug Manufacturing/Marketing Approvals ...... 40 3 Approval And Licenses 3 Priority Review System .................................... 44 Approval Review ............................................ 40 30-Day reports (ADR) ....................................... 160 Approval Reviews .................................. → Review 7 Approval System for Regenerative Medicine ..... 43 7-Day reports (ADR) ......................................... 107 Article 42 of the Pharmaceutical Affairs Law ...... 52 A B ADR reporting system Biological products ............................................. 24 Reporting by MHLW ...................................... 158 Biosimilar biological products ............................. 48 Reporting by pharmaceutical companies ...... 158 Biosimilar Products ...........................................124 ADR reporting system by pharmaceutical Biotechnological products .................................121 companies .................................................... 158 Blood and Blood Products Division (PFSB) ......... 4 Adverse Drug Reaction (ADR) and Infection Brand Names of Prescriptions Drugs ................182 Reporting ........................................................ 36 bridging studies .................................................. 80 Advertisement C Restriction and Prohibition .............................. 32 Certificates Issued by MHLW ............................. 49 Age classification for pediatric use .................... 180 Classification of reexamination approval ...........166 AIDS Research Center (NIID) ............................. 12 Clinical development/studies Approval and licenses Management of studies:Clinical Acceptance of foreign clinical trial data ........... 80 development/studies Application forms ............................................ 41 Management of clinical studies........................ 112 Data required for approval applications .......... 75 Phase I of clinical studies ............................... 96 General ........................................................... 40 Phase II of clinical studies .............................. 96 Manufacturing license requirements for drugs119 Phase III of clinical studies ............................. 97 Approval and Licenses Phases of studies........................................... 95 Approval Applications for Drugs Manufactured Requirements for sponsoring:Clinical in Foreign Countries ................................... 49 2014-3 - 219 - development/studies Safety information .........................................183 Requirements for sponsoring .......................... 111 Dissemination of information on adverse reactions Requirements for sponsors ........................... 115 to drugs .........................................................189 Clinical studies Drug Abuse Control ............................................ 39 Management of studies:Clinical studies Drug development Management of studies ................................... 112 Process from development to approval.......... 67 Requirements for sponsors:Clinical studies Drug Master File (MF) ........................................ 29 Requirements for sponsors ............................. 115 Drug pricing .......................................................196 Clinical Studies.................................................... 92 Drug pricing system Requirements for sponsoring:Clinical Studies Entry of generic drugs in the NHI price list ....204 Requirements for sponsoring .......................... 111 Medical benefits under NHI programs ...........197 Clinical study reports (FSR) .............................. 100 NHI price list..................................................199 Codevelopment Of Drugs ................................... 48 NHI reimbursement of medical fees ..............198 Commentaries on Precautions in package inserts190 Pricing formula for reimbursement price Compliance and Narcotics Division (PFSB) .......... 4 revisions ...................................................200 Compliance review Recent revisions of NHI price list ..................201 Data for reexamination and reevaluation ...... 157 Reimbursement prices for new drugs ...........202 GMP Drug Safety Update...........................................189 Compliance review GMP ................................. 119 Drug Seller Licensing Reexamination and reevaluation .................. 157 Necessity ....................................................... 30 Compliance Reviews ............................. → Review Drugs Compliance surveys Classification .................................................. 22 Status for for reexamination based on GPSP157 Definition ........................................................ 22 CTD Module 1 ............................................. → CTD Quality Standards and Government CTD Module 2: Data summaries ................. → CTD Certification ................................................ 31 CTD Module 3: Quality................................ → CTD Quality Standards Based on Notifications ...... 54 CTD Module 4: Nonclinical study reports .... → CTD Drugs for Pediatric Use ...................................... 46 CTD Module 5: Clinical study reports .......... → CTD Drugs using materials of human or animal origin Drugs using materials of human or animal D origin .........................................................123 Data to be Attached to Approval Application ....... 79 E DEVELOPMENT OF NEW DRUGS .................... 67 Dissemination of drug information Early post-marketing phase vigilance PMS: Early post-marketing phase General ................................................... 37, 174 2014-3 Economic Affairs Division (HPB) .......................... 5 - 220 - Electronic information dissemination Standards to assure quality...........................121 Safety information ......................................... 190 Good Clinical Practice (GCP) ............................. 33 Emergency safety information ( ........................ 185 Good Laboratory Practice (GLP) ........................ 32 Entry of generic drugs in the NHI price list ........ 204 Good Laboratory Practice (GLP) ........................ 87 Evaluation and Licensing Division (PFSB) ............ 2 Good Manufacturing Practice (GMP) →Necessity .................................................... 29 G Good Post-marketing Study Practice (GPMSP) . 35 GCP Good Post-marketing Surveillance Practice General requirements ................................... 108 (GPMSP) ......................................................140 Ordinance on standards for conduct of clinical Good Vigilance Practice (GVP) .................. → GVP studies ........................................................ 67 Government Batch Test General Affairs Division (PFSB) ............................ 2 Quality Of Drugs ............................................ 54 Global harmonization of GMP GPMSP .......................................................35, 140 Mutual approvals of GMP ............................. 120 GPSP ................................................................152 GLP Compliance status for reexamination ............157 Ordinance on standards for conduct of Guidelines nonclinical studies on the safety of drugs ... 67 Clinical evaluation .........................................101 GMP Specifications of drugs:Guidelines: Compliance review Specifications of drugs ............................... 82 GMP Guidelines Concerning Drug Approval Compliance review ....................................... 119 Applications .. → Approval application guidelines Global harmonization Guidelines for bioequivalence Studies ............... 91 GMP Guidelines for General Pharmacological Studies 89 Mutual approvals .......................................... 120 Guidelines for Pharmacokinetic Studies ............. 90 Investigational products GMP Guidelines for Stability Tests .............................. 83 Investigational products ................................... 116 Guidelines for Toxicity Tests ............................... 85 Standards to assure quality of imported drugs Guidelines on Physicochemical Properties, (GMPI) Specifications, and Tests Methods→ Specifications: Quality GMP H Standards to assure quality of imported drugs (GMPI) ...................................................... 121 Health insurance programs ...............................196 GMPI History ...........................................................196 Standards to assure quality Health Policy Bureau (HPB) .............................. 5 GMPI 2014-3 History of health insurance programs................196 - 221 - Manufacturing/Marketing License ...................... 25 I Marketing Approvals ICH.................................................................... 126 →Necessity .................................................... 28 ICH pyramid ................................................. → ICH Medical benefits under NHI programs ...............197 IF Microdose studies .............................................. 98 Pharmaceutical Interview Forms................... 183 Ministry of Health, Labour, and Welfare (MHLW) Infectious Diseases Information Center (NIID) .... 12 Organization and function ................................ 1 Information for drugs which completed reexamination or reevaluation....................... 189 N International Conference on Harmonization (ICH) National Institute of Biomedical Innovation ........ 10 International Conference on Harmonization National Institute of Health Sciences (Health (ICH) ......................................................... 126 Sciences) ......................................................... 6 Interview advice meetings .. → PMDA consultations National Institute of Infectious Diseases (NIID) .. 12 Investigational product GMP Investigational NHI price list ......................................................199 product GMP................................................. 116 NHI reimbursement of medical fees ..................198 Investigational products Nonclinical studies Quality ............................................................ 95 Requirements................................................. 94 Issues Related to the Use of Determination of Nonclinical Studies .............................................. → Unapproved Drugs and Off-label Use ........... 204 Non-prescription drug Package inserts ............................................191 J Non-prescription drugs ....................................... 23 Japan Health Sciences Foundation (HPB) ............ 6 Non-prescription Drugs .......................................... Japanese Pharmacopoeia (JP) ........................... 50 → Approval application: Non-prescription drugs L O Labeling and Package Inserts Office of Cellular and Tissue-based Products ...... 9 Necessity ........................................................ 31 Office of Chemical Safety (PFSB) ........................ 3 Labeling of excipients ....................................... 180 Office of Compliance and Standards (PMDA) .... 10 Law Concerning Access to Information ............... 37 Office of Direction for Health-Related Services M (HPB) ............................................................... 5 Manufacturing Businesses License..................... 25 Office of Drug Induced Damages (PFSB) ............ 2 Manufacturing license requirements for drugs .. 119 Office of International Programs (PMDA) ............. 8 Manufacturing/Marketing Approvals Office of Medical Devices Evaluation (PFSB) ...... 3 Necessity ........................................................ 26 2014-3 Office of Medical Devices I (PMDA) ..................... 9 - 222 - Office of Medical Devices II (PMDA) ................... 10 Pharmaceutical and Food Safety Bureau (PFSB) 2 Office of Medical Devices III (PMDA) .................. 10 Pharmaceutical inspections ............................... 54 Office of New Drug I (PMDA) ................................ 8 Pharmaceutical Interview Forms (IF) ................183 Office of New Drug II (PMDA) ............................... 9 Pharmaceutical laws and regulations ................. 17 Office of New Drug III (PMDA) .............................. 9 Pharmaceuticals and Medical Devices Agency Office of New Drug IV (PMDA).............................. 9 (PMDA, KIKO).................................................. 6 Office of OTC and Generics (PMDA) .................... 9 Pharmacological studies Office of Review Administration (PMDA) ............... 8 Requirements................................................. 94 Office of Review Management (PMDA) ................ 8 Phase I of clinical studies Office of Safety (PMDA) ...................................... 10 Phase I of clinical studies ............................... 96 Office of Standards and Guidelines Development Phase II of clinical studies .................................. 96 (PMDA) ............................................................. 8 Phase III of clinical studies ................................. 97 Office of Vaccines and Blood Products (PMDA) ... 9 Phase III of clinical studies ............................. 97 On-site reviews ...................................... → Review PMS ..................................................................140 Orphan Drugs ..................................................... 45 SOP ..............................................................145 Outline of pharmaceutical regulations ................. 22 Post-marketing surveillance (PMS) ...................140 Outline of prescription of drug information ........ 182 Precautions (package inserts) ...........................178 Prescription drugs .............................................. 22 P Prescription Drugs.................................................. Package inserts → Approval application: Prescription drugs Background................................................... 174 Prevention of Medical Accidents ........................ 55 Commentaries on Precautions...................... 190 Pricing formula for reimbursement price revisions200 Guidelines ..................................................... 175 Priority Review ................................................... 44 Headings and their sequence ....................... 177 Priority reviews ................................................... 17 Information to supplement package Inserts .. 182 Product Recalls ...................................................... Non-prescription drugs ................................. 191 → Recall Style and format ............................................ 176 Public disclosure of information on new drug Package Inserts in English ................................ 182 development .................................................125 Paper reviews ........................................ → Review R Patent System..................................................... 38 Periodic safety reports ...................................... 164 Recent revisions of NHI price list ......................201 Pharmaceutical Affairs and Food Sanitation Reevaluation Council (PAFSC) ............................................. 11 General .......................................................... 35 Pharmaceutical Affairs Law ................................. 17 System ..........................................................167 2014-3 - 223 - Reexamination Reporting system by Medical Personnel .......161 Data and procedures .................................... 165 WHO safety monitoring program...................162 Data for review.............................................. 115 Safety Measures against Bovine ........................ 56 Designated classifications ............................ 166 Safety monitoring Designation of drugs ..................................... 163 During clinical studies ...................................107 General ........................................................... 35 Safety studies System .......................................................... 162 Requirements................................................. 94 Reexamination and reevaluation SOP for PMS.....................................................145 Information for drugs which completed Specifications of drugs: Guidelines:Specifications reexamination or reevaluation .................. 189 of drugs: Guidelines ....................................... 82 Reexamination and reevaluation Specified biological products .............................. 24 Compliance review data................................ 157 Stability tests of drugs Reimbursement prices for new drugs ............... 202 Guidelines:Stability tests of drugs Research and Development Division (HPB) ......... 5 Guidelines......................................................... 82 Reviews and Guidance by the PMDA (KIKO) ..... 68 Standards for Biological Materials ...................... 53 Risk Management Plan ....................................... 36 Studies of drug interactions ................................ 98 Risk management plan (RMP) PMS: Risk management planStudies (RMP) of drug metabolites ................................ 98 S U Safety Division (PFSB) ......................................... 4 Unapproved drugs and drugs of off-label use .... 47 Safety flash report ........................................... 187 W safety information WHO safety monitoring program .......................162 Safety information Electronic information dissemination ............ 190 Periodic safety reports .................................. 164 2014-3 - 224 - English Regulatory Information Task Force Leader: Katsunori KURUSU (Chapter 1) Katsunori KURUSU Regulatory Development Regulatory Affairs Sanofi KK (Chapter 2) Tsuyoshi KOBAYASHI Japan Development Regulatory Affairs Global Regulatory Affairs CFU Eisai Co, Ltd Katsunori INUI Regulatory Affairs Takeda Pharmaceutical Company Limited (Chapter 3) Yoshiyuki YONEDA New Drug Regulatory Affairs Daiichi Sankyo Co, Ltd Kazuhiro SASAKI Regulatory Development, Regulatory Affairs Research and Development Janssen Pharmaceutical KK Kanji HIRAI Regulatory Affairs Area, Japan Development MSD KK 2014-3 - 225 - Yasuhiro HASEGAWA Development Regulatory Affairs Mitsubishi Tanabe Pharma Corp (Chapter 4) Kazuyo MARUCHI Product Development Regulatory Affairs Shionogi & Co, Ltd (Chapter 5) Takashi TSUJI Pharmacovigilance and Quality Assurance Kyowa Hakko Kirin Co, Ltd Yuichi TAKIDO Quality & Regulatory Compliance Chugai Pharmaceutical Co, Ltd (Chapter 6) Toshio SATO Regulatory Affairs Otsuka Pharmaceutical Co, Ltd Translation Takumi ISHIDA Japan Medical Linguistics Institute Contact: JPMA Liaison International Affairs JPMA E-Mail: international @ jpma.or.jp 2014-3 - 226 - PHARMACEUTICAL ADMINISTRATION AND REGULATIONS IN JAPAN Prepared: March 2014 Edited by ENGLISH REGULATORY INFORMATION TASK FORCE INTERNATIONAL AFFAIRS COMMITTEE © JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION Torii-Nihonbashi Bldg., 3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan Phone 81-3 (3241) 0326 Fax 81-3 (3242) 1767 http://www.jpma.or.jp/12english/index.html 2014-3 - 227 -
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