-
September 18, 2025
Safety
New
PMDA Alert for Proper Use of Drugs: No. 7 Compliance with Measurement of Blood Lithium Levels during Treatment with Lithium Carbonate (revision) posted
-
September 17, 2025
Safety
New
Revisions of PRECAUTIONS: Tarlatamab (genetical recombination) 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 4, 2025
Other
Recent Publications by PMDA Staff updated
-
September 2, 2025
Review
English translation of review report: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
-
September 1, 2025
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (September 2025) posted
-
August 29, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.422 posted
-
August 28, 2025
Safety
Revisions of PRECAUTIONS: Delandistrogene moxeparvovec posted
-
August 26, 2025
Review
List of Approved CDx（Companion Diagnostics）: Updated Aug 20, 2025
-
August 25, 2025
JP
PDG Revision of Q-09 Particulate contamination News posted
-
August 22, 2025
Int
PMDA Updates (2025 Summer) posted
-
August 14, 2025
Review
English Translation of Review Report: Tasfygo
-
August 8, 2025
Safety
PMDA Risk Communication: Mesalazine, etc. posted
-
August 7, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
-
August 7, 2025
Review
List of Approved Medical Devices: April 2004 to December 2024
-
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
-
July 15, 2025
Int
Call for PMDA-ATC Herbal Medicine Review Seminar 2025 has been opened
-
July 11, 2025
Review
Information on biosimilars is updated
-
July 1, 2025
Review
List of Approved Drugs: April 2004 to March 2025
-
July 1, 2025
Int
Training materials have been updated.
-
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
-
June 6, 2025
Review
Points to Consider for Clinical Development of Drugs Intended for Treatment of Antimicrobial-resistant Gram-negative Bacterial Infections (Early Consideration) 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 28, 2025
Review
English Translation of Review Report: Akuugo
-
April 18, 2025
Safety
PMDA Risk Communication: Onasemnogene abeparvovec posted
-
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