INFORMATION ON JAPANESE REGULATORY AFFAIRS

Transcription

1 2017 INFORMATION ON JAPANESE REGULATORY AFFAIRS Regulatory Information Task Force Japan Pharmaceutical Manufacturers Association Pharmaceutical Administration and Regulations in Japan Japan Pharmaceutical Manufacturers Association

2 (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 ( Japan Pharmaceutical Manufacturers Association

3 Table of Contents CHAPTER ORGANIZATION AND FUNCTION OF THE MINISTRY OF HEALTH, LABOUR AND WELFARE PHARMACEUTICAL SAFETY AND ENVIRONMENTAL HEALTH BUREAU (PSEHB) General Affairs Division Pharmaceutical Evaluation Division Medical Device Evaluation Division Safety Division Compliance and Narcotics Division Blood and Blood Products Division HEALTH POLICY BUREAU Economic Affairs Division Research and Development Division NATIONAL INSTITUTE OF HEALTH SCIENCES PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA), AN INDEPENDENT ADMINISTRATIVE ORGANIZATION Office of Review Administration Office of Review Management Office of Standards and Guidelines Development Office of New Drug I Office of New Drug II Office of New Drug III Office of New Drug IV Office of New Drug V Office of Cellular and Tissue-based Products Office of Vaccines and Blood Products Office of OTC and Generics Office of Generics Office of Medical Devices I Office of Medical Devices II Office of Medical Devices III Office of Compliance and Standards Office of Safety I Office of Safety II Office of Manufacturing/Quality and Compliance Office of International Programs Advanced Review with Electronic Data Promotion Gruop Kansai Branch Hokuriku Branch NATIONAL INSTITUTE OF BIOMEDICAL INNOVATION, HEALTH AND NUTRITION (NIBIOHN) JAPAN AGENCY FOR MEDICAL RESEARCH AND DEVELOPMENT (AMED) PHARMACEUTICAL AFFAIRS AND FOOD SANITATION COUNCIL (PAFSC) NATIONAL INSTITUTE OF INFECTIOUS DISEASES... 9 CHAPTER PHARMACEUTICAL LAWS AND REGULATIONS PHARMACEUTICAL LAWS PHARMACEUTICAL AND MEDICAL DEVICE ACT OUTLINE OF PHARMACEUTICAL REGULATIONS Definition of Drugs Definition of Drugs License for Manufacturing/Marketing Businesses License for Manufacturing Business and Accreditation of Overseas i

4 Manufacturers Manufacturing/Marketing Approvals Good Manufacturing Practice (GMP) Drug Master File (MF) Drug Retail Seller Licensing Labeling and Package Inserts Proper Advertisement Good Laboratory Practice (GLP) Good Clinical Practice (GCP) Trial Conducted from a Compassionate Viewpoint (expanded trial) Patient-requested Therapy System Good Post-marketing Study Practice (GPSP) Reexamination and Reevaluation Adverse Drug Reaction (ADR) and Infection Reporting Risk Management Plan Dissemination of Information Measures related to the Law Concerning Access to Information Held by Administrative Organizations Patent System Drug Abuse Control MARKETING APPROVALS Drug Marketing Approvals Marketing Approval Reviews Manufacturing/Marketing Approval Application with Electronic Data Priority Review System and Designation of Drug Products for Priority Reviews Restrictive Approval System Orphan Drugs Drugs for Pediatric Use Unapproved Drugs and Drugs of Off-label Use Packaging Strategy for World-first Products Regulatory Strategy Consultations for Regenerative Medicine Products Approval System Implemented to Promote the Application of Regenerative Medicine Including Cellular and Tissue-Based Products for Commercialization (Approval with Conditions and Time Limit) Biosimilar Products Combination Products Codevelopment Transfer of Marketing Approvals Approval Applications for Drugs Manufactured Overseas Issuing of Certificates for Exported Drugs by MHLW JAPANESE PHARMACOPOEIA AND OTHER STANDARDS Japanese Pharmacopoeia (JP) Standards Based on Article 42 of the Pharmaceutical Affairs Law Standards for Biological Materials Quality Standards Based on Notifications Government Batch Test PHARMACEUTICAL SUPERVISION Pharmaceutical Supervision Product Recalls Prevention of Medical Accidents Caused by Drugs, etc Safety Measures against Bovine Spongiform Encephalitis (BSE) CHAPTER DRUG DEVELOPMENT PROCESS FROM DEVELOPMENT TO APPROVAL Development of New Drugs Procedures for Clinical Trials Safety information on Adverse ii

5 Reactions and Infections during the Study Interview advice meetings Approval review Compliance review GMP compliance inspection DATA REQUIRED FOR APPROVAL APPLICATIONS Data to be Attached to Approval Application of Drugs GUIDELINES CONCERNING DRUG APPROVAL APPLICATIONS Nonclinical Studies Clinical Studies OTHER Biotechnological Products Drugs Using Materials of Human or Animal Origin as Ingredients (Biological Products) Biosimilar Products Public Disclosure of Information on New Drug Development ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) CHAPTER POST-MARKETING SURVEILLANCE OF DRUGS GVP GPSP PAPER COMPLIANCE REVIEW AND ON-SITE GPSP SURVEYS OF DATA FOR REEXAMINATION AND REEVALUATION ADVERSE DRUG REACTIONS AND INFECTIONS REPORTING SYSTEM Adverse Drug Reaction and Infectious Disease Reporting System by Pharmaceutical Companies Drug and Medical Device Safety Information Reporting System by Medical Personnel WHO International Drug Monitoring Program PERIODIC INFECTION REPORTS FOR BIOLOGICAL PRODUCTS (ARTICLE AND IN THE LAW) REEXAMINATION SYSTEM (ARTICLE 14-4 AND OF THE PHARMACEUTICAL AFFAIRS LAW) Designation for Reexamination of Drugs Periodic Safety Reports (Article 63 of the Enforcement Regulations of the Law) Data Required for Reexamination Applications and Reexamination Procedures REEVALUATION SYSTEM (ARTICLES 14-6 AND OF THE LAW) CHAPTER SUPPLY AND DISSEMINATION OF DRUG SAFETY MANAGEMENT INFORMATION PACKAGE INSERTS 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 INFORMATION TO SUPPLEMENT PACKAGE INSERTS Outline of Prescription iii

6 Pharmaceutical Product Information Pharmaceutical Interview Forms (IF) SUPPLY AND DISSEMINATION OF SAFETY MANAGEMENT INFORMATION Distribution of Emergency Safety Information (Yellow Letters) Safety Flash Report (Blue Letters) Distribution of Information by 'Notices of Revision of Precautions' Dissemination of Information for Drugs That Have Completed Reexamination or Reevaluation Dissemination of ADR Information by the Pharmaceuticals and Medical Devices Safety Information (Information on Adverse Reactions to Drugs) Dissemination of Information by Drug Safety Update Commentaries on "Precautions" in Package Inserts of New Drugs ELECTRONIC INFORMATION DISSEMINATION PACKAGE INSERTS OF NON-PRESCRIPTION DRUGS PACKAGE INSERTS OF GUIDANCE-MANDATORY DRUGS CHAPTER HEALTH INSURANCE PROGRAMS AND DRUG PRICING IN JAPAN HISTORY OF HEALTH INSURANCE PROGRAMS MEDICAL BENEFITS OFFERED UNDER HEALTH INSURANCE PROGRAMS REIMBURSEMENT OF MEDICAL FEES NATIONAL HEALTH INSURANCE PRICE LIST PRICING FORMULA FOR REIMBURSEMENT PRICE REVISIONS OF DRUGS LISTED IN THE NHI PRICE LIST RECENT REVISIONS OF THE NHI PRICE LIST DETERMINATION OF REIMBURSEMENT PRICES FOR NEW DRUGS ENTRY OF GENERIC DRUGS IN THE NHI PRICE LIST ISSUES RELATED TO THE USE OF DETERMINATION OF UNAPPROVED DRUGS AND OFF-LABEL USE Fig. 1 Organization of Ministry of Health, Labour, and Welfare (Health-related organizations only) Fig. 2 Organization of Pharmaceutical Safety and Environmental Health Bureau (PSEHB) and Pharmaceuticals and Medical Devices Agency (PMDA) Fig. 3 Organization of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) Fig. 4 Flowchart of Patent-Life Extension Fig. 5 Flowchart of Approval Review Fig. 6 Procedure for manufacturing and marketing approval of drugs for overseas manufacturers in Japan Fig. 7 Flowchart of Drug Listing in Japanese Pharmacopoeia Table 1 List of Main Controlled Substances.. 51 Table 2 Divisions of the Pharmaceutical and Food Safety Bureau in Charge of Certification Work Fig. 8 Flowchart of New Drug Development and Approval iv

7 Fig. 9 Timeline of the standard process of new drug approval Table 3 Data to be Submitted with an Application for Approval to Manufacture/Market: A New Prescription Drug Table 4 Data to be Submitted with an Application for a Non-prescription Drug Table 5 Classification of Clinical Studies According to Objectives Fig. 10 Organization of ICH Common Technical Documents Fig. 11 Correlation between Development Phases and Types of Study Table 6 ICH topics and guidelines - Progress of harmonization Fig. 12 Pharmaceutical Post-marketing Surveillance System Fig. 13 Post-marketing Collection and Reporting of Pharmaceutical Safety Information Fig. 14 Collection and Reporting of Pharmaceutical Safety Information Fig. 15 Reexamination System Fig. 16 Reevaluation System Fig. 17 Layout of a Package Insert for a Prescription Drug (with Warning ) Fig. 18 Standard procedures for revision of package insert (1) Fig. 19 Standard procedures for revision of package insert (2) Fig. 20 Reimbursement Pricing Flow-sheet for New Drugs Fig. 21 Correlation between the Time of Marketing Approval Based on Pharmaceutical Affairs Law and the Time of Entry in the NHI Price List Table 7 Methods of Previous Reimbursement Price Revisions Table 9 Requirements for Applying Premiums v