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https://www.pmda.go.jp/
PMDA RSS Feeden[SHINSA]English Translation of Review Report: Akuugo (Partial Change Approval)
https://www.pmda.go.jp/english/review-services/reviews/approved-information/0004.html
Pharmaceuticals and Medical Devices Agency2026-09-03T12:00:00+09:00[SHINSA]Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.
https://www.pmda.go.jp/english/review-services/regulatory-info/0005.html
Pharmaceuticals and Medical Devices Agency2026-09-03T12:00:00+09:00[KOKUSAI]PMDA-ATC Training Materials have been updated
https://www.pmda.go.jp/english/int-activities/training-center/0003.html
Pharmaceuticals and Medical Devices Agency2026-09-01T12:00:00+09:00[SHINSA]Available 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 Agency2026-08-31T12:00:00+09:00[IBENTO][IBENTO]Report of PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026
https://www.pmda.go.jp/english/symposia/0362.html
Pharmaceuticals and Medical Devices Agency2026-08-31T12:00:00+09:00[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.430 posted
https://www.pmda.go.jp/english/safety/info-services/drugs/medical-safety-information/0024.html
Pharmaceuticals and Medical Devices Agency2026-08-28T12:00:00+09:00[ANZEN]Revisions of PRECAUTIONS: Tucatinib ethanolate, etc. posted
https://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0014.html
Pharmaceuticals and Medical Devices Agency2026-08-28T12:00:00+09:00[SHINSA]CDx approved for identifying eligible patients (Updated)
https://www.pmda.go.jp/english/rs-sb-std/rs/0027.html
Pharmaceuticals and Medical Devices Agency2026-08-28T12:00:00+09:00[ANZEN]PMDA Risk Communications: Azathioprine etc. posted
https://www.pmda.go.jp/english/safety/info-services/drugs/risk-communications/0001.html
Pharmaceuticals and Medical Devices Agency2026-08-25T12:00:00+09:00[SHINSA]One-Stop Service Platform by ENSEMBLExJ page updated
https://www.pmda.go.jp/english/review-services/f2f-pre/0009.html
Pharmaceuticals and Medical Devices Agency2026-08-18T12:00:00+09:00[SHINSA]English Translation of Review Report: Beovu (Partial Change Approval)
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html
Pharmaceuticals and Medical Devices Agency2026-08-17T12:00:00+09:00[SHINSA]English 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+09:00[SHINSA]List 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+09:00[SHINSA]Information on biosimilars is updated
https://www.pmda.go.jp/english/review-services/reviews/0005.html
Pharmaceuticals and Medical Devices Agency2026-08-03T12:00:00+09:00[IBENTO][IBENTO]ASEAN-Japan Medical Devices Regulatory Symposium 2026 Report
https://www.pmda.go.jp/english/symposia/0361.html
Pharmaceuticals and Medical Devices Agency2026-07-28T12:00:00+09:00[IBENTO][IBENTO]ASEAN-Japan Medical Devices Regulatory Seminar 2026
https://www.pmda.go.jp/english/symposia/0359.html
Pharmaceuticals and Medical Devices Agency2026-07-24T12:00:00+09:00[KOKUSAI]The 8th Asian Network Meeting (ANM) summary has been posted
https://www.pmda.go.jp/english/int-activities/asia/0004.html
Pharmaceuticals and Medical Devices Agency2026-07-24T12:00:00+09:00[YAKKYOKUKATA]Press Release regarding international activities related to Pharmacopoeia posted
https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0012.html
Pharmaceuticals and Medical Devices Agency2026-07-13T12:00:00+09:00[KOKUSAI]PMDA Updates (2026 No.2) posted
https://www.pmda.go.jp/english/int-activities/outline/0006.html
Pharmaceuticals and Medical Devices Agency2026-07-10T12:00:00+09:00[PMDA]PMDA Concludes a Memorandum of Understanding with the London School of Hygiene & Tropical Medicine (LSHTM) (News Release) (July 6, 2026) [222KB]
https://www.pmda.go.jp/english/about-pmda/0025.pdf
Pharmaceuticals and Medical Devices Agency2026-07-07T12:00:00+09:00[PMDA]Conclusion of a Memorandum of Understanding between the Medical University of Vienna and the Pharmaceuticals and Medical Devices Agency (PMDA) (News Release) (June 30, 2026) [263KB]
https://www.pmda.go.jp/english/about-pmda/0024.pdf
Pharmaceuticals and Medical Devices Agency2026-07-01T12:00:00+09:00[ANZEN]PMDA Alert for Proper Use of Drugs: Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group (follow-up report) posted
https://www.pmda.go.jp/english/safety/info-services/drugs/properly-use-alert/0001.html
Pharmaceuticals and Medical Devices Agency2026-06-30T12:00:00+09:00[SHINSA]List 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+09:00[IBENTO][IBENTO]The report for the PMDA Asia office GCP workshop 2026 has been posted.
https://www.pmda.go.jp/english/symposia/0356.html
Pharmaceuticals and Medical Devices Agency2026-06-19T12:00:00+09:00[IBENTO][IBENTO]The report for the PMDA Asia office GMP Workshop Training 2026 has been posted.
https://www.pmda.go.jp/english/symposia/0355.html
Pharmaceuticals and Medical Devices Agency2026-06-19T12:00:00+09:00[YAKKYOKUKATA]PDG March 2026 News posted
https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0014.html
Pharmaceuticals and Medical Devices Agency2026-06-12T12:00:00+09:00[SHINSA]List 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[IBENTO][IBENTO]Workshop on New Approach Methodologies (NAMs) Held following ICCR-20
https://www.pmda.go.jp/english/symposia/0354.html
Pharmaceuticals and Medical Devices Agency2026-06-10T12:00:00+09:00[SONOTA]"Project team for Consideration of Guiding Principles for AI Utilization" has been added in “Projects Across Multi-Offices”
https://www.pmda.go.jp/english/rs-sb-std/rs/0015.html
Pharmaceuticals and Medical Devices Agency2026-06-08T12:00:00+09:00[IBENTO][IBENTO]Report on the PMDA-ATC 10th Anniversary Ceremony has been posted.
https://www.pmda.go.jp/english/symposia/0352.html
Pharmaceuticals and Medical Devices Agency2026-06-04T12:00:00+09:00[IBENTO][IBENTO]Symposium for the 10 anniversary of the PMDA Hokuriku Branch
https://www.pmda.go.jp/english/symposia/0353.html
Pharmaceuticals and Medical Devices Agency2026-06-01T12:00:00+09:00[YAKKYOKUKATA]Schedule of JP19-I Publication posted
https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0009.html
Pharmaceuticals and Medical Devices Agency2026-05-27T12:00:00+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+09:00[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 Agency2026-05-19T12:00:00+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 Agency2026-05-13T12:00:00+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 Agency2026-04-27T12:00:00+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 Agency2026-04-27T12:00:00+09:00