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• Regulations and services of PMDA
• Information for approved products in Japan
• Procedures in Japan
• Advanced efforts
• FAQ

Regulations and services of PMDA

• Reviews

• Safety Measures - Outline

• Safety Measures - RMP

• GLP / GCP / GPSP Compliance Assessments

• GMP / QMS / GCTP Inspections

• Japanese Pharmacopeia

• Medical Device Standards

• Regulatory Information

Information for approved products in Japan

• New Drugs

• New Medical Devices

• Regenerative Medical Products

• Companion Diagnostics

Procedures in Japan

• Master File System

• Accreditation of Foreign Manufacturers

Advanced efforts

• Science Board

• Office of Advanced Evaluation with Electronic Data

• Strategy of SAKIGAKE by MHLW

• Projects Across Multi-Offices in PMDA

FAQ

• Frequently Asked Questions (FAQ)