Japanese regulatory affairs

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  • 1.2010.3 INFORMATION IN ENGLISH ON JAPANESE REGULATORY AFFAIRSEnglish Regulatory Information Task Force Japan Pharmaceutical Manufacturers AssociationPharmaceutical Administration and Regulations in Japan

2. March 2 0 1 0 http://www.jpma.or.jp/about/issue/gratis/index2.html (Japanese) http://www.jpma.or.jp/english/parj/1003.html (English)Pharmaceutical Administration and Regulations in JapanThis file contains information concerning pharmaceutical administration, regulations, and new drug development in Japan updated annually by the English RA Information Task Force, International Affairs Committee, Japan Pharmaceutical Manufacturers Association (JPMA).The contents are notabstracts of governmental rules or regulations but concise descriptions of most current practices by regulatory agencies and the industry that the working group complies.The file does not contain anything related toforecasts. The file is available also at the homepage of National Institute of Health Sciences (http://www.nihs.go.jp/kanren/iyaku.html).Japan Pharmaceutical Manufacturers Association http://www.jpma.or.jp/english/ 3. 4.9Table of ContentsOffice of Compliance and Standards 94.105.Office of Safety ........................... 9The National Institute of BiomedicalInnovation (Independent Administrative Agency) ............................................... 9 6.Pharmaceutical Affairs and FoodSanitation Council (PAFSC) ............. 10CHAPTER 1 ................................................. 17. ORGANIZATION AND FUNCTION OF THE MINISTRYNational Institute of InfectiousDiseases ............................................. 11OF HEALTH, LABOUR AND WELFARE ............. 1CHAPTER 2 ............................................... 161. Pharmaceutical and Food SafetyPHARMACEUTICAL LAWS AND REGULATIONS16Bureau (PFSB) ................................... 2 1.1 General Affairs Division ..................... 2Pharmaceutical Affairs Law ......... 163.Outline of Pharmaceutical1.4 Compliance and Narcotics Division ... 4Regulations ......................................... 201.5 Blood and Blood Products Division.... 43.1 Definition of Drugs ........................... 21Health Policy Bureau..................... 53.2 Classification of Drugs ..................... 212.1 Economic Affairs Division .................. 53.3 Licenses for Marketing Businesses and2.2 Research and Development Division. 5Manufacturing Businesses .................... 23National Institute of Health Sciences3.4 Marketing Approvals ........................ 246 4.2.1.3 Safety Division................................... 43.Pharmaceutical Laws .................. 161.2 Evaluation and Licensing Division ..... 22.1.3.5 Good Manufacturing Practice (GMP)25Pharmaceuticals and Medical Devices3.6 Drug Master File (MF) ................... 25Agency (PMDA, Sogo-kiko), an3.7 Accreditation of Overseas Manufacturersindependent administrative organization6.............................................................. 264.1Office of New Drug I.................... 73.8 Drug Retail Seller Licensing ............ 284.2Office of New Drug II................... 83.9 Quality Standards and Government4.3Office of New Drug III.................. 8Certification ........................................... 284.4Office of New Drug IV ................. 83.10 Labeling and Package Inserts ....... 284.5Office of Biologics I ..................... 83.11 Restrictions and Prohibition of4.6Office of Biologics II .................... 8Advertising............................................. 294.7Office of OTC and Generics........ 93.12 Good Laboratory Practice (GLP). 294.8Office of Medical Devices............ 93.13 Good Clinical Practiceiii(GCP)...... 30 4. 3.14 Good Post-Marketing Study Practice.............................................................. 49(GPSP) .................................................. 325.5 Government Batch Test ................... 496.3.15 Reexamination and Reevaluation.. 32 3.16 Adverse Drug Reaction(ADR) andPharmaceutical Supervision........ 49 6.1 Pharmaceutical Supervision ............ 49Infection Reporting ................................ 326.2 Product Recalls ............................... 503.17 Dissemination of Information ......... 336.3 Prevention of Medical Accidents Caused3.18 Measures related to the Lawby Drugs, etc. ........................................ 50Concerning Access to Information Held by6.4 Safety Measures against BovineAdministrative Organizations................. 33Spongiform Encephalitis3.19 Patent System ............................... 34(BSE) ........... 51CHAPTER 3 ............................................... 603.20 Drug Abuse Control ....................... 354.DRUG DEVELOPMENT ................................ 60MARKETING Approvals .............. 361.4.1 Drug Marketing Approvals ............... 36Approval and License ......................... 604.2 Marketing Approval Reviews ........... 361.1 Development of New Drugs............. 604.3 Priority Review System and Designation1.2 Reviews and Guidance by the PMDAof Drug Products for Priority Reviews.... 39(SOGO-KIKO)........................................ 614.4 Restrictive Approval System............ 401.3 Approval Reviews ............................ 644.5 Orphan Drugs .................................. 412.4.6 Drugs for Pediatric Use ................... 412.1 Data to be Attached to Approval4.8 Transfer of Marketing Approvals ...... 43Application of Drugs .............................. 684.9 Approval Applications for Drugs3.Manufactured Overseas ........................ 43Guidelines Concerning Drug ApprovalApplications......................................... 694.10 Issuing of Certificates by MHLW.... 443.1 Nonclinical Studies .......................... 704.11 Issuing Certificates Based on the Who3.2 Clinical Studies ................................ 80Certification System .............................. 454.Japanese Pharmacopoeia and OtherRequirements for Drug Manufacturingand Marketing Approvals andStandards............................................ 45 5.1 Japanese PharmacopoeiaData Required for ApprovalApplications......................................... 654.7 Codevelopment ............................... 435.Process from Development toManufacturing Business Licenses .... 105(JP)..... 454.1 GMP Compliance Reviews ............ 1135.2 Standards Based on Article 42 of the4.2 Mutual Recognition of GMP........... 114Pharmaceutical Affairs Law ................... 474.3 Regulations for Imported Drug5.3 Standards for Biological Materials ... 48Management and Quality Control ........ 1155.4 Quality Standards Based on Notifications5.ivOthers........................................ 115 5. of the Pharmaceutical Affairs Law) ... 1525.1 Biotechnological Products ..............115 5.2 Drugs Using Materials of Human or6.1 Designation for Reexamination of DrugsAnimal Origin as Ingredients (Biological............................................................ 153Products) ..............................................1176.2 Periodic Safety Reports5.3 Public Disclosure of Information on Newthe Enforcement Regulations of the Law)153Drug Development ...............................1186.3 Data Required for Reexamination5.4 ICHApplications and Reexamination Procedures(International Conference onHarmonization of Technical Requirements for(Article 63 of............................................................ 154Registration of Pharmaceuticals for Human7.Reevaluation System (Article 14-5Use)......................................................119of the PAL) ........................................ 156CHAPTER 4 ............................................. 132CHAPTER 5 ............................................. 163POST-MARKETING SURVEILLANCE OF DRUGSSUPPLY AND DISSEMINATION OF DRUG.............................................................. 132INFORMATION .......................................... 1631.GPSP ........................................ 1332.1.Data Compliance Surveys andPackage Inserts......................... 163 1.1 Summary of the New Guidelines ... 165Compliance Surveys of MARKETERS1.2 Headings and Their Sequence inBased on GPSP................................ 138Package Inserts................................... 1653.GVP........................................... 1391.3 Precautions.................................... 1674.Adverse Drug Reactions and1.4 Labeling of Excipients.................... 169Infections Reporting System............. 1471.5 Entries for Biological Products....... 1704.1 Drug Safety Information Reporting1.6 Brand Names of Prescriptions Drugs170System by Medical Personnel ............. 1471.7 Information on Package Inserts in4.2 Adverse Drug Reaction and InfectiousEnglish................................................. 171Disease Reporting System by2.Information to Supplement PackagePharmaceutical Companies................. 147Inserts ............................................... 1714.3 WHO International Drug Monitoring Program............................................... 150Product Information ............................. 1714.4 Evaluation and Communication of Safety2.2 New Drug Approval Information PackageInformation and Adoption of Specific(NAIP).................................................. 171Measures............................................. 1505.2.1 Outline of Prescription Pharmaceutical2.3 Summary Basis of ReexaminationPeriodic Infection Reports for(SBR)................................................... 172Biological Products ........................... 1512.4 Pharmaceutical Interview Forms (IF)6............................................................. 172Reexamination System (Article 14-4v 6. 3.Supply and Dissemination of SafetyDrug Price List .................................. 182 6.Management Information.................. 172Recent Revisions of the NHI Drug3.1 Distribution of Emergency SafetyPrice List ...........................................