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Safety Alert & Recalls/ Review Reports/ Package Inserts etc.

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For Regulatory Authorities
Regulations & Services of PMDA
Information about Approved Products in Japan
Safety Information
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- Frequently Asked Questions (FAQ)
For Healthcare Professionals
Information for approved products in Japan
Safety information
FAQ
- Frequently Asked Questions (FAQ)
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Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
Regulatory science
- The Science Board
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- Frequently Asked Questions (FAQ)
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Regulations and services of PMDA
Information for approved products in Japan
Procedures in Japan
- Master File System
- Accreditation of Foreign Manufacturers
Advanced efforts
FAQ
- Frequently Asked Questions (FAQ)

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Drugs
Regulations and Services of PMDA
Information for apporoved products in Japan
- New drugs
Safety information
Procedures in Japan
- Master File System
- Accreditation of Foreign Manufacturers
Advanced efforts
Medical devices
Regulations and Services of PMDA
Information for apporoved products in Japan
- New devices
Safety information
- PMDA Medical Safety Information
Procedures in Japan
- Accreditation of Foreign Manufacturers
Advanced efforts
Quasi-drugs
Reviews and Related Services
Regulatory Procedures
- Accreditation of Foreign Manufacturers
Post-marketing Safety Measures
- Outline of Post-marketing Safety Measures
Regenerative medical products
Reviews and Related Services
Post-marketing Safety Measures
- Outline of Post-marketing Safety Measures
Advanced Efforts
- CPC (Cell Processing Center) Subcommittee
- Cellular and Tissue-based Products Subcommittee

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International Activities
International Harmonization

International Activities

International Harmonization

As clearly stated in PMDA International Strategic Plan 2015, PMDA is proactively participating in international harmonization activities and strengthening its contributions to them. PMDA contribute to the following harmonization activities.