-
February 16, 2026
Review
New
English Translation of Review Report: Spikevax (Partial Change Approval)
-
February 16, 2026
Safety
New
PMDA Medical Safety Information: Precautions for Handling of Gastrostomy Catheters（No.72） posted
-
February 16, 2026
Other
New
Recent Publications by PMDA Staff updated
-
February 12, 2026
Review
New
One-Stop Service Platform by ENSEMBLExJ page created
-
February 10, 2026
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.426 posted
-
February 10, 2026
Safety
Revisions of PRECAUTIONS: Cytarabine , etc. posted
-
February 6, 2026
JP
PDG October 2025 Meeting Highlights posted
-
February 6, 2026
Int
PMDA Updates (2026 No.1) posted
-
February 5, 2026
Review
Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation (Early Consideration), Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals (Early Consideration),Consideration in the development of drugs for hypertrophic cardiomyopathy (Early Consideration) posted
-
February 4, 2026
Safety
English Translated Package Inserts page: Ensure Liquid updated
-
February 4, 2026
Review
List of Approved Medical Devices: April 2004 to June 2025
-
February 2, 2026
Int
New PMDA-ATC Learning Video content has been released on the Pmda Channel
-
January 29, 2026
Review
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
-
January 26, 2026
Review
Software as a Medical Device (SaMD) page updated
-
January 19, 2026
Review
Information on biosimilars is updated
-
January 16, 2026
Safety
PMDA Risk Communications: Aciclovir etc. posted
-
January 13, 2026
Safety
Revisions of PRECAUTIONS: Idecabtagene vicleucel etc,posted
-
January 9, 2026
Review
English translation of review report: ENDEAVORRIDE
-
January 7, 2026
Safety
Notifications on Self-Inspection （In Vitro Diagnostics）: Self-inspection etc. of Package Inserts of Blood Glucose Meters, etc.posted
-
January 7, 2026
Safety
Notifications on Self-Inspection（In Vitro Diagnostics）: Self-inspection etc. of Package Inserts of Blood Glucose Meters, etc.posted
-
January 7, 2026
Safety
Notifications on Self-Inspection
-
December 25, 2025
Int
Report of PMDA-ATC Pharmaceuticals Review Webinar 2025 posted
-
December 23, 2025
Review
List of Approved Products: April 2015 to November 2025
-
December 22, 2025
Events
The 11th Thailand-Japan Symposium
-
December 17, 2025
Review
List of Approved Drugs: April 2004 to June 2025
-
December 12, 2025
Review
English Translation of Review Report: JACC (Partial Change Approval)
-
December 8, 2025
Pub cmt
JP Drafts (December 2025) posted
-
December 8, 2025
Other
Information on AI Action Working Group is now available
-
December 5, 2025
Safety
PMDA Risk Communication: Idecabtagene vicleucel etc. posted
-
December 5, 2025
JP
PDG October 2025 News posted
-
November 28, 2025
Review
Regulatory Information updated
-
November 28, 2025
Review
Quasi-Drugs page created
-
November 28, 2025
Review
Review Reports : Quasi-Drugs page created
-
November 28, 2025
Review
Others updated
-
November 17, 2025
Events
Report of the ACCSQ PPWG - PMDA-ATC Pharmaceuticals Review Seminar 2025
-
November 17, 2025
Events
Report of the PMDA-ATC GMP Inspection Seminar 2025
-
November 14, 2025
Review
Information on new modalities is now available
-
November 13, 2025
JP
Revised PDG Working Procedure posted
-
November 10, 2025
Events
Report of the PMDA-ATC Medical Devices Webinar 2025 for AMDC
-
October 22, 2025
Events
PMDA-ATC Pharmacovigilance Seminar 2026 applications open
-
October 14, 2025
Review
The information of New Drug Review with Electronic Data updated
-
October 10, 2025
Review
New Modalities and NAMs page created
-
October 8, 2025
Other
Action Plan for the Use of AI in Operations at the PMDA(News Release) (October 10, 2025)
-
October 6, 2025
Review
Rationalization of descriptions in the specification column in approval application forms for prescription drugs, Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with Manufacturing Process Changes, Handling of Prescription Drugs Having Different Crystalline Forms, etc., Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs posted
-
September 30, 2025
Int
PMDA Washington D.C. Office Map Refreshed
-
September 26, 2025
Events
PMDA-ATC Pharmaceuticals Review Webinar 2025 applications open
-
September 26, 2025
Events
PMDA-ATC MRCT/GCP Inspection Seminar 2026 applications open
-
September 18, 2025
Safety
PMDA Alert for Proper Use of Drugs: No. 7 Compliance with Measurement of Blood Lithium Levels during Treatment with Lithium Carbonate (revision) posted
-
September 10, 2025
Events
PMDA-ATC Medical Devices Webinar 2025 for AMDC
-
September 8, 2025
Pub cmt
JP Drafts (September 2025) posted
-
September 5, 2025
Review
GMP / GCTP Annual Report FY 2024 posted
-
September 4, 2025
Events
Report of the PMDA-ATC Review of CGTP products Seminar 2025 for South-East Asian Countries
-
September 1, 2025
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (September 2025) posted
-
August 7, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
-
August 1, 2025
Events
Report of PMDA-ATC Pediatric Review Seminar 2025
-
July 30, 2025
Review
New radiopharmaceuticals page created
-
July 25, 2025
Events
Joint Statement on Cooperation between Japan and the Republic of Korea on Medical Products Regulations
-
July 23, 2025
Safety
PMDA Risk Communications (medical devices risk information of ongoing evaluation): Cadaveric dura mater posted
-
July 18, 2025
Int
HBD East 2025 Think Tank Meeting
-
July 15, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
-
July 15, 2025
Events
Call for PMDA-ATC Herbal Medicine Review Seminar 2025 has been opened
-
June 30, 2025
Int
Information of IMDRF2025 Sapporo Meeting (September 15 to 19) available now.
-
June 10, 2025
Events
ASEAN-Japan Medical Devices Regulatory Symposium 2025 Report
-
June 9, 2025
Pub cmt
JP Drafts (June 2025) Part 1 posted
-
June 9, 2025
Pub cmt
JP Drafts (June 2025) Part 2 posted
-
May 27, 2025
Events
ASEAN-Japan Medical Devices Regulatory Seminar 2025 Report
-
May 16, 2025
Events
PMDA-ATC GMP Inspection Seminar 2025
-
April 30, 2025
Events
The 3rd Malaysia-Japan Symposium website is opened
-
April 18, 2025
Review
“Initiatives to Promote Pediatric Drug Development” posted
-
April 9, 2025
JP
Implementation of ICH-Q3D into Japanese Pharmacopoeia updated
-
April 3, 2025
Events
PMDA-ATC Review of CGTPs Seminar 2025 for South-East Asian countries
- Home
- What's New