Pharmaceutical Administration and Regulations in Japan - Nihs

3.12 Good Laboratory Practice (GLP) ····· 29
3.13 Good Clinical Practice (GCP) ········· 30
3.14 Good Post-marketing Study Practice
(GPSP) ············································ 32
3.15 Reexamination and Reevaluation ···· 32
3.16 Adverse Drug Reaction (ADR) and
Infection Reporting ····························· 33
3.17 Dissemination of Information ·········· 33
3.18 Measures related to the Law
Concerning Access to Information Held by
Administrative Organizations ················ 33
3.19 Patent System ···························· 35
3.20 Drug Abuse Control ······················ 35
4. MARKETING Approvals ·············· 36
4.1 Drug Marketing Approvals ··············· 36
4.2 Marketing Approval Reviews ············ 37
4.3 Priority Review System and Designation
of Drug Products for Priority Reviews······ 39
4.4 Restrictive Approval System ············ 41
4.5 Orphan Drugs ······························· 41
4.6 Drugs for Pediatric Use ··················· 41
4.7 Biosimilar products ························ 43
4.8 Codevelopment ····························· 43
4.9 Transfer of Marketing Approvals ······· 44
4.10 Approval Applications for Drugs
Manufactured Overseas ······················· 44
4.11 Issuing of GMP Certificates for Exported
Drugs and Investigational Products by
MHLW ·············································· 44
4.12 Issuing Certificates Based on the WHO
Certification System ···························· 45
5. Japanese Pharmacopoeia and Other
Standards ······································· 46
iv
5.1 Japanese Pharmacopoeia (JP) ········· 46
5.2 Standards Based on Article 42 of the
Pharmaceutical Affairs Law ··················· 48
5.3 Standards for Biological Materials ······ 48
5.4 Quality Standards Based on Notifications
······················································· 50
5.5 Government Batch Test ··················· 50
6. Pharmaceutical Supervision ········· 50
6.1 Pharmaceutical Supervision ············· 50
6.2 Product Recalls ····························· 51
6.3 Prevention of Medical Accidents Caused
by Drugs, etc. ····································· 51
6.4 Safety Measures against Bovine
Spongiform Encephalitis (BSE) ·············· 51
CHAPTER 3 ········································· 61
DRUG DEVELOPMENT ····························· 61
1. Process from Development to
Approval ········································ 61
1.1 Development of New Drugs ·············· 61
1.2 Reviews and Guidance by the PMDA
(KIKO) ·············································· 62
1.3 Approval Reviews ··························· 65
2. Data Required for Approval
Applications ···································· 67
2.1 Data to be Attached to Approval
Application of Drugs ····························· 70
3. Guidelines Concerning Drug Approval
Applications ···································· 71
3.1 Nonclinical Studies ························· 73
3.2 Clinical Studies ······························ 83
4. Requirements for Drug Manufacturing
and Marketing Approvals and
Manufacturing Business Licenses ······ 108