PMDA：Top All https://www.pmda.go.jp/ PMDA RSS Feed en [SHINSA]List of therapeutic products for which eligible patients can be identified by Drug-Agnostic CDx,posted https://www.pmda.go.jp/english/rs-sb-std/rs/0027.html Pharmaceuticals and Medical Devices Agency 2026-05-20T12:00:00+09:00 [ANZEN]PMDA Risk Communications: Ferric carboxymaltose etc. posted https://www.pmda.go.jp/english/safety/info-services/drugs/risk-communications/0001.html Pharmaceuticals and Medical Devices Agency 2026-05-19T12:00:00+09:00 [YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0027.html Pharmaceuticals and Medical Devices Agency 2026-05-19T12:00:00+09:00 [SHINSA]English Translation of Review Report: Setaneo https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html Pharmaceuticals and Medical Devices Agency 2026-05-15T12:00:00+09:00 [SHINSA]Seven 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 Agency 2026-05-13T12:00:00+09:00 [IBENTO][IBENTO]PMDA-ATC GMP Inspection Seminar 2026 applications open https://www.pmda.go.jp/english/symposia/0351.html Pharmaceuticals and Medical Devices Agency 2026-05-12T12:00:00+09:00 [SHINSA]Software as a Medical Device (SaMD) page updated https://www.pmda.go.jp/english/review-services/reviews/0009.html Pharmaceuticals and Medical Devices Agency 2026-05-11T12:00:00+09:00 [SHINSA]Points to Consider for Small Clinical Trials (Early Consideration) posted https://www.pmda.go.jp/english/review-services/regulatory-info/0005.html Pharmaceuticals and Medical Devices Agency 2026-05-11T12:00:00+09:00 [KOKUSAI]PMDA-ATC Learning videos have been updated https://www.pmda.go.jp/english/int-activities/training-center/0003.html Pharmaceuticals and Medical Devices Agency 2026-05-01T12:00:00+09:00 [YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0026.html Pharmaceuticals and Medical Devices Agency 2026-04-27T12:00:00+09:00 [ANZEN]PMDA Medical Safety Information: Use of Insulin-Specific Syringe- Incorrect dose may cause serious adverse health effects- posted https://www.pmda.go.jp/english/safety/info-services/safety-information/0001.html Pharmaceuticals and Medical Devices Agency 2026-04-27T12:00:00+09:00 [KOKUSAI]Information on PMDA Asia Office updated https://www.pmda.go.jp/english/int-activities/overseas-office/asia/0001.html Pharmaceuticals and Medical Devices Agency 2026-04-27T12:00:00+09:00 [ANZEN]Revisions of PRECAUTIONS: Infliximab (genetical recombination) and biosimilars , etc. posted https://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0014.html Pharmaceuticals and Medical Devices Agency 2026-04-21T12:00:00+09:00 [KOKUSAI]A new page for the Regulatory Symposia has been launched. https://www.pmda.go.jp/english/int-activities/asia/0015.html Pharmaceuticals and Medical Devices Agency 2026-04-20T12:00:00+09:00