PMDA：Reviews and Related Services All
https://www.pmda.go.jp/
PMDA RSS FeedenEnglish Translation of Review Report: Optune Lua and Esprit BTK Everolimus Eluting Resorbable Scaffold System
https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html
Pharmaceuticals and Medical Devices Agency2026-08-14T12:00:00+09:00List of Approved Regenerative Medical Products: April 2015 to May 2026
https://www.pmda.go.jp/english/review-services/reviews/approved-information/0002.html
Pharmaceuticals and Medical Devices Agency2026-08-05T12:00:00+09:00English Translation of Review Report: Avarept
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html
Pharmaceuticals and Medical Devices Agency2026-08-04T12:00:00+09:00Information on biosimilars is updated
https://www.pmda.go.jp/english/review-services/reviews/0005.html
Pharmaceuticals and Medical Devices Agency2026-08-03T12:00:00+09:00Considerations for the Clinical Evaluation of Blood Coagulation Factor VIII and Factor IX Products for Pediatric Congenital Hemophilia (Early Consideration) posted.
https://www.pmda.go.jp/english/review-services/regulatory-info/0005.html
Pharmaceuticals and Medical Devices Agency2026-07-24T12:00:00+09:00Available schedule for consultation by the Office of Software as a Medical Device updated
https://www.pmda.go.jp/english/review-services/reviews/0009.html
Pharmaceuticals and Medical Devices Agency2026-07-21T12:00:00+09:00English Translation of Review Report: RiHEART
https://www.pmda.go.jp/english/review-services/reviews/approved-information/0004.html
Pharmaceuticals and Medical Devices Agency2026-07-17T12:00:00+09:00CDx approved for identifying eligible patients (Updated June 16, 2026)
https://www.pmda.go.jp/english/rs-sb-std/rs/0027.html
Pharmaceuticals and Medical Devices Agency2026-06-22T12:00:00+09:00List of Approved Drugs: April 2004 to February 2026
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html
Pharmaceuticals and Medical Devices Agency2026-06-22T12:00:00+09:00List of Approved Medical Devices: April 2004 to September 2025
https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0001.html
Pharmaceuticals and Medical Devices Agency2026-06-11T12:00:00+09:00[SHINSA]The new website “Overview of Orphan Drug Designation“ launched.
https://www.pmda.go.jp/english/review-services/reviews/0011.html
Pharmaceuticals and Medical Devices Agency2026-05-22T12:00:00+09:00[SHINSA]The new website “Designation / Early Access“ launched.
https://www.pmda.go.jp/english/review-services/reviews/0010.html
Pharmaceuticals and Medical Devices Agency2026-05-22T12:00:00+09:00Seven English translations of notifications and administrative notices related to pediatric drug development, including the partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”
https://www.pmda.go.jp/english/review-services/regulatory-info/0012.html
Pharmaceuticals and Medical Devices Agency2026-05-13T12:00:00+09:00