PMDA：Top Reviews
https://www.pmda.go.jp/
PMDA RSS FeedenEnglish 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+09:00English Translation of Review Report: Vorzzz
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html
Pharmaceuticals and Medical Devices Agency2026-07-16T12:00:00+09:00Checklist for Quality-Related Documents for Biotechnology Products Derived from Cell Lines of Human or Animal Origin at the Time of Initial Clinical Trial Notification（Early Consideration）posted.
https://www.pmda.go.jp/english/review-services/regulatory-info/0005.html
Pharmaceuticals and Medical Devices Agency2026-07-13T12:00:00+09:00Software as a Medical Device (SaMD) page updated
https://www.pmda.go.jp/english/review-services/reviews/0009.html
Pharmaceuticals and Medical Devices Agency2026-07-06T12:00:00+09:00English Translation of Review Report: SUSMED App for Insomnia Medcle (Partial Change Approval)
https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html
Pharmaceuticals and Medical Devices Agency2026-06-30T12:00:00+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