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

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About PMDA

About PMDA

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

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Reviews and Related Services
Post-marketing Safety Measures
Relief Services for Adverse Health Effects
- Outline
- Public comments
Regulatory Science/The Science Board/Standard Development
International Activities

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For Regulatory Authorities
Regulations & Services of PMDA
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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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- Frequently Asked Questions (FAQ)
For Business
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- Frequently Asked Questions (FAQ)

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Information for apporoved products in Japan
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Medical devices
Regulations and Services of PMDA
Information for apporoved products in Japan
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Procedures in Japan
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Quasi-drugs
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Regenerative medical products
Reviews and Related Services
Post-marketing Safety Measures
- Outline of Post-marketing Safety Measures
Advanced Efforts
- CPC (Cell Processing Center) Subcommittee
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International Activities
Cooperation with Asia

International Activities

Cooperation with Asia

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Multilateral Cooperation
Bilateral Cooperation

International Activities

Outline
- Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization
- Information from PMDA
  - PMDA Updates
  - Chief Executive’s Statement
For Industry - for development in Japan
International Harmonization
- ICMRA
- APEC-RHSC
Bilateral Arrangements and Cooperation
- Confidential Arrangements
- Memorandum of Understanding/Memorandum of Cooperation
- Other cooperation schemes
  - Tripartite Meeting (for Antibacterial Agents)
  - Tripartite Meeting (for GCP Inspection)
  - Cooperation between WHO and PMDA on training for regulatory authorities
Cooperation with Asia
- Multilateral Cooperation
  - Asian Network Meeting (ANM)
- Bilateral Cooperation
Asia Training Center
Overseas Office
- PMDA Asia Office
- PMDA Washington D.C. Office
  - PMDA Washington D.C. Office General Consultation Service
Public comments

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