PMDA:Reviews and Related Services All
https://www.pmda.go.jp/
PMDA RSS FeedenData Standards Catalog and Study Data Validation Rules posted
https://www.pmda.go.jp/english/review-services/reviews/0002.html
Pharmaceuticals and Medical Devices Agency2024-03-29T12:00:00+09:00Information on biosimilars is now available
https://www.pmda.go.jp/english/review-services/reviews/0005.html
Pharmaceuticals and Medical Devices Agency2024-03-27T12:00:00+09:00English translation of ‘Guideline for Ensuring Quality, Safety, and Efficacy of Biosimilars’ is now available
https://www.pmda.go.jp/english/review-services/regulatory-info/0003.html
Pharmaceuticals and Medical Devices Agency2024-03-27T12:00:00+09:00GMP / GCTP Annual Report FY 2022 posted
https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0007.html
Pharmaceuticals and Medical Devices Agency2024-03-27T12:00:00+09:00English Translation of Review Report: TS-1 (Partial Change Approval)
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html
Pharmaceuticals and Medical Devices Agency2024-03-12T12:00:00+09:00