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Regulations & Services of PMDA
Information about Approved Products in Japan
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Information for approved products in Japan
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Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
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Regulations and services of PMDA
Information for approved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Reviews and Related Services
Post-marketing Safety Measures
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Reviews and Related Services
Post-marketing Safety Measures
Regulatory Science/The Science Board/Standard Development
The 2nd Pharmaceuticals Subcommittee Meeting
Press Release
Date and Time: November 1, 2012 from 5pm to 7pm
Agenda / List of Handouts
Agenda
- Relationship among new drug development, review, and post-marketing safety measures
- Future issues to discuss
- Others
List of Handouts
- Document 1 Reorganization of Offices of Biologics and their new work assignment
- Document 2 Relations among new drug development, review and post-marketing safety measures
- Document 3 Targeted outcomes of the Subcommittees
- Document 4 Flow from suggestion to adoption of agendas of the Subcommittees
- Document 5-1 Proposed agenda of the Pharmaceuticals Subcommittee
- Document 5-2 Proposed agenda of the Bio-products Subcommittee
- Ref.1 Overview of review for approval and post-marketing safety measures