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Pmda - Pharmaceuticals and Medical Devices Agency

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

Formats DL

About PMDA

About PMDA

Formats DL

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
Advanced Efforts
FAQ
- Frequently Asked Questions (FAQ)
For Healthcare Professionals
Information for approved products in Japan
Safety information
FAQ
- Frequently Asked Questions (FAQ)
For Academia
Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
Regulatory science
- The Science Board
FAQ
- Frequently Asked Questions (FAQ)
For Business
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

Reviews and Related Services

Public comments

Open public comments

Currently, there is no applicable information.

Closed public comments

Currently, there is no applicable information.