2015 - JPMA

1 2015. INFORMATION ON japanese REGULATORY AFFAIRS. Regulatory Information Task Force Japan Pharmaceutical Manufacturers Association Pharmaceutical Administration and Regulations in Japan Japan Pharmaceutical Manufacturers Association 2015. ( japanese ). (English). Pharmaceutical Administration and Regulations in Japan This 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 not abstracts 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 to forecasts. The file is available also at the homepage of National Institute of Health Sciences ( ).

2 Japan Pharmaceutical Manufacturers Association Good Manufacturing Practice (GMP) 15. Drug Master File (MF) .. 15. Table of Contents Drug Retail Seller Licensing .. 15. Quality Standards and Government Certification .. 16. Labeling and Package Inserts16. Proper Advertisement .. 16. CHAPTER 1 .. 1 Good Laboratory Practice (GLP) 16. ORGANIZATION AND FUNCTION OF THE MINISTRY OF Good Clinical Practice (GCP) 16. HEALTH, LABOUR AND 1 Good Post-marketing Study Practice (GPSP). 17. Reexamination and Reevaluation 17. 1. PHARMACEUTICAL AND FOOD SAFETY BUREAU Adverse Drug Reaction (ADR) and Infection (PFSB) .. 1 Reporting .. 18. General Affairs Division .. 1 Risk Management Plan .. 18. Evaluation and Licensing Division 1 Dissemination of Information18. Safety Division .. 2 Measures related to the Law Concerning Compliance and Narcotics Division 2 Access to Information Held by Administrative Blood and Blood Products Division 2 Organizations.

3 18. 2. HEALTH POLICY BUREAU .. 3 Patent System .. 19. Economic Affairs Division .. 3 Drug Abuse Control .. 19. Research and Development Division 3 4. MARKETING APPROVALS .. 20. 3. NATIONAL INSTITUTE OF HEALTH SCIENCES 3 Drug Marketing Approvals .. 20. 4. PHARMACEUTICALS AND MEDICAL DEVICES Marketing Approval Reviews .. 20. AGENCY (PMDA), AN INDEPENDENT Manufacturing/Marketing Approval Application ADMINISTRATIVE ORGANIZATION3 with Electronic Data .. 21. Office of Review Administration4 Regulatory Strategy Consultations for Office of Review Management 4 Regenerative Medicine Products 21. Office of Standards and Guidelines Approval System Implemented to Promote the Development .. 4 Application of Regenerative Medicine Office of International Programs 4 Including Cellular and Tissue-Based Products Office of New Drug 4 for Commercialization (Approval with Office of New Drug II .. 4 Conditions and Time Limit).

4 21. Office of New Drug III .. 4 Priority Review System and Designation of Drug Office of New Drug IV .. 4 Products for Priority Reviews21. Office of New Drug V .. 5 Restrictive Approval System .. 22. Office of Cellular and Tissue-based Products Orphan Drugs .. 22. 5 Drugs for Pediatric Use .. 22. Office of Vaccines and Blood Products 5 Unapproved Drugs and Drugs of Off-label Use Office of OTC and Generics .. 5 23. Office of Generics .. 5 Packaging Strategy for World-first Products Office of Medical Devices I .. 5 23. Office of Medical Devices II . 5 Biosimilar Products .. 23. Office of Medical Devices III 5 Combination Products .. 24. Office of Compliance and Standards 5 24. Office of Safety I .. 5 Transfer of Marketing Approvals 24. Office of Safety II .. 5 Approval Applications for Drugs Manufactured Electronic Data Promotion Group 5 Overseas .. 24. 5. THE NATIONAL INSTITUTE OF BIOMEDICAL Issuing of Certificates for Exported Drugs by INNOVATION (INDEPENDENT ADMINISTRATIVE MHLW.)

5 24. AGENCY) .. 5 5. japanese PHARMACOPOEIA AND OTHER. 6. PHARMACEUTICAL AFFAIRS AND FOOD STANDARDS .. 25. SANITATION COUNCIL (PAFSC) .. 5 japanese Pharmacopoeia (JP) 25. 7. NATIONAL INSTITUTE OF INFECTIOUS Standards Based on Article 42 of the 6 Pharmaceutical Affairs Law . 25. Standards for Biological Materials26. CHAPTER 2 .. 11 Quality Standards Based on Notifications 26. PHARMACEUTICAL LAWS AND REGULATIONS 11 Government Batch Test .. 26. 6. PHARMACEUTICAL SUPERVISION26. Pharmaceutical Supervision .. 26. 1. PHARMACEUTICAL LAWS .. 11 Product Recalls .. 27. 2. DRUGS AND MEDICAL DEVICES LAW 11 Prevention of Medical Accidents Caused by 3. OUTLINE OF PHARMACEUTICAL REGULATIONS Drugs, etc.. 27.. 12 Safety Measures against Bovine Spongiform Definition of Drugs .. 12 Encephalitis (BSE) .. 27. Definition of Drugs .. 12 CHAPTER 3---------------------------35. License for Manufacturing/Marketing Businesses Drug Development.

6 13. License for Manufacturing Business and 1. PROCESS FROM DEVELOPMENT TO APPROVAL 35. Accreditation of Overseas Manufacturers 14 Development of New Drugs Manufacturing/Marketing Approvals 15 Procedures for Clinical Trials i Safety information on Adverse Reactions and 3. SUPPLY AND DISSEMINATION OF SAFETY. Infections during the Study MANAGEMENT INFORMATION------94. Interview advice meetings Distribution of Emergency Safety Information Approval review (Yellow Letters). Compliance review Safety Flash Report (Blue Letters). GMP compliance inspection Distribution of Information by 'Notices of Revision of Precautions'. 2. DATA REQUIRED FOR APPROVAL. APPLICATIONS------------------------41 Dissemination of Information for Drugs That Have Completed Reexamination or 3. GUIDELINES CONCERNING DRUG APPROVAL Reevaluation APPLICATIONS------------------------43. Dissemination of ADR Information by the 4. Other------------------------------57 Pharmaceuticals and Medical Devices Safety Information (Information on Adverse Reactions CHAPTER 4 --------------- ----------73 to Drugs).

7 Post-marketing Surveillance of Drugs Dissemination of Information by Drug Safety Update 1. GVP-------------------------------74 Commentaries on "Precautions" in Package Inserts of New Drugs 2. GPSP------------------------------78 4. ELECTRONIC INFORMATION DISSEMINATION. 3. PAPER COMPLIANCE REVIEW AND ON-SITE GPSP ---------------------------------------- 97. SURVEYS OF DATA FOR REEXAMINATION AND. 5. PACKAGE INSERTS OF NON-PRESCRIPTION. REEVALUATION-----------------------80 DRUGS -------------------------------98. 4. ADVERSE DRUG REACTIONS AND INFECTIONS. REPORTING SYSTEM-----------------80 6. PACKAGE INSERTS OF GUIDANCE-MANDATORY. DRUGS--------------------------------98. Adverse Drug Reaction and Infectious Disease Reporting System by Pharmaceutical Companies CHAPTER 6 ------------------------102. Drug and Medical Device Safety Information Health Insurance Programs and Drug Pricing Reporting System by Medical Personnel in Japan WHO International Drug Monitoring Program 5.

8 PERIODIC INFECTION REPORTS FOR 1. HISTORY OF HEALTH INSURANCE. BIOLOGICAL PRODUCTS (ARTICLE 68-14 and 68-24 PROGRAMS-------------------------102. in THE LAW)---------------------------82 2. MEDICAL BENEFITS OFFERED UNDER HEALTH. 6. REEXAMINATION SYSTEM (ARTICLE 14-4 AND INSURANCE PROGRAMS ----------102. 23-29 OF THE PHARMACEUTICAL AFFAIRS LAW) 82 3. REIMBURSEMENT OF MEDICAL FEES ---103. Designation for Reexamination of Drugs 4. NATIONAL HEALTH INSURANCE PRICE LIST. Periodic Safety Reports (Article 63 of the --------------------------------------10 3. Enforcement Regulations of the Law) 5. PRICING FORMULA FOR REIMBURSEMENT PRICE. Data Required for Reexamination Applications REVISIONS OF DRUGS LISTED IN THE NHI PRICE. and Reexamination Procedures LIST --------------------------------103. 7. REEVALUATION SYSTEM (ARTICLES 14-6 AND 6. RECENT REVISIONS OF THE NHI PRICE LIST. 23-31 OF THE LAW) -----------------83 ------------------------------------ 104.

9 7. DETERMINATION OF REIMBURSEMENT PRICES. FOR NEW DRUGS -----------------104. CHAPTER 5 --------------------------90. Supply and Dissemination of Drug Safety 8. ENTRY OF GENERIC DRUGS IN THE NHI PRICE. LIST --------------------------------105. Management Information 9. ISSUES RELATED TO THE USE OF. DETERMINATION OF UNAPPROVED DRUGS AND. 1. PACKAGE INSERTS --------------90 OFF-LABEL USE--------------------105. Guidance on the Style and Format of Package Inserts Headings and Their Sequence in Package Inserts Precautions Labeling of Excipients Entries for Biological Products Brand Names of Prescriptions Drugs Information on Package Inserts in English 2. INFORMATION TO SUPPLEMENT PACKAGE. INSERTS------------------------------94. Outline of Prescription Pharmaceutical Product Information Pharmaceutical Interview Forms (IF). ii CHAPTER 1 approval reviews, reviews throughout post-marketing stage, and pharmaceutical safety measures.

10 (Fig. 2. Organization of Pharmaceutical and Food Safety Bureau Organization and Function of the (PFSB) and Pharmaceuticals and Medical Devices Agency Ministry of Health, Labour and (PMDA)). Welfare 1. PHARMACEUTICAL AND FOOD SAFETY BUREAU. (PFSB). The Ministry of Health, Labour, and Welfare (MHLW) The Pharmaceutical and Food Safety Bureau (PFSB). (Koseirodosho in japanese ) was established by a merger of (except for the Department of Food Safety) is one of the 11. the Ministry of Health and Welfare (MHW) and the Ministry bureaus of the MHLW. In addition to polices to assure the of Labour, on January 6, 2001 as part of the government efficacy and safety of drugs, quasi-drugs, cosmetics and program for reorganizing government ministries. The medical devices, and policies for safety in medical MHLW, which was originally established in 1938, has been institutions, the PFSB tackles problems directly related to in charge of the improvement and promotion of social the lives and heath of the general public including policies welfare, social security and public health, and the new related to blood supplies and blood products, and narcotics organization has the same tasks.