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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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Back

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

Events and Symposia

Public comments

What's new

What's new

October 22, 2025

Drug

IVD

New

Revisions of PRECAUTIONS: Lubiprostone, etc. posted

Currently, there is no applicable information.

October 21, 2025

Other

New

Recent Publications by PMDA Staff updated

Currently, there is no applicable information.

Services of PMDA

Reviews and Related Services

Clinical trials, reviews, consultations, compliance assessments, and inspections concerning applications for drugs, medical devices, regenerative medical products, etc.

Post-marketing Safety Measures

Collection and provision of information regarding post-marketing safety and scientific research and analyses on data collected.

Relief Services for Adverse Health Effects

Relief Systems for Adverse Drug Reactions.

Regulatory Science

Regulatory science research, the Science Board, projects across multi-offices in PMDA, and standards development (e.g., Japanese Pharmacopoeia, medical device standards).

International Activities

International harmonization activities such as collaboration with overseas regulatory authorities and international organizations, participation in international meetings including ICH, and activities related to Asia Training Center.