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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
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- Frequently Asked Questions (FAQ)
For Healthcare Professionals
Information for approved products in Japan
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FAQ
- Frequently Asked Questions (FAQ)
For Academia
Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
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- The Science Board
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- Frequently Asked Questions (FAQ)
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Information for approved products in Japan
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- 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
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Procedures in Japan
- Accreditation of Foreign Manufacturers
Advanced efforts
Quasi-drugs
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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
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Training Materials
Learning Videos : Advanced Therapy Medicinal Products

International Activities

Learning Videos : Advanced Therapy Medicinal Products

(Note) You will be transferred to an external website (YouTube : Pmda Channel) by clicking the title below. There is also PLAYLIST that sequentially plays all the movies in this category.

[PLAYLIST]

Review of Regenerative Medicinal Product
Non-clinical Safety Evaluation for Cellular and Tissue-based Products April 1, 2025 Updated
Non-clinical Safety Evaluation for in vivo Gene Therapy Products April 1, 2025 Updated
Quality Control for Cell and Gene Therapy Products
Cartagena Act