-
March 28, 2024
Safety
Revisions of PRECAUTIONS (Regenerative Medical Products): Axicabtagene ciloleucel, etc. posted
-
March 28, 2024
Safety
Revisions of PRECAUTIONS: Andexanet alfa (genetical recombination) posted
-
March 27, 2024
Review
Information on biosimilars is now available
-
March 27, 2024
Review
English translation of ‘Guideline for Ensuring Quality, Safety, and Efficacy of Biosimilars’ is now available
-
March 27, 2024
Review
GMP / GCTP Annual Report FY 2022 posted
-
March 14, 2024
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.408
-
March 12, 2024
Events
PMDA-ATC Pharmaceuticals Review Seminar 2024 for PPWG member states
-
March 7, 2024
Pub cmt
JP Drafts (March 2024) posted
-
March 1, 2024
Safety
PMDA Risk Communication: Axicabtagene ciloleucel, etc. posted
-
February 29, 2024
Safety
Notifications Related to Safety Measures (In-vitro Diagnostics) : Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. posted
-
February 29, 2024
Safety
Notifications Related to Safety Measures (Regenerative Medical Products): Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. posted
-
February 29, 2024
Safety
Notifications Related to Safety Measures (Drugs): Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. posted
-
February 22, 2024
JP
PDG October 2023 Meeting Highlights posted
-
February 20, 2024
Review
PMDA’s Support to Venture Companies posted
-
February 15, 2024
Safety
PMDA Medical Safety Information: Precautions for Blood Purification in Patients Receiving ACE Inhibitors(No.68)posted
-
February 14, 2024
Review
English Translation of Review Report: Luxturna
-
January 24, 2024
Review
List of Approved Products (Medical Devices): April 2004 to June 2023
-
December 27, 2023
Safety
English Translated Package Inserts page: Ensure Liquid updated
-
December 27, 2023
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
-
December 8, 2023
Events
The 10th Thailand-Japan Symposium
-
December 7, 2023
Pub cmt
JP Drafts (December 2023) posted
-
December 7, 2023
Sci board
The 4th Subcommittee on Cell and Gene Therapy Products Produced in vivo
-
December 6, 2023
Other
【Warning】 Please Be Aware of Phishing E-mails Pretending to be from the PMDA (December 6, 2023)
-
December 1, 2023
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (December, 2023) posted
-
November 20, 2023
Events
PMDA-ATC Pharmacovigilance Webinar 2024
-
November 17, 2023
Events
The 4th Vietnam-Japan Symposium
-
October 31, 2023
Events
PMDA-ATC GMP Inspection Webinar 2024
-
October 27, 2023
JP
PDG October 2023 Press Release posted
-
October 23, 2023
Other
Profile of Services posted
-
October 17, 2023
Events
PMDA-ATC/AMDC Medical Devices Webinar 2023
-
October 12, 2023
Int
ICMRA statement on the safety of COVID-19 vaccines
-
October 12, 2023
Int
ICMRA (International Coalition of Medicines Regulatory Authorities) updated
-
October 6, 2023
Sci board
The 3rd Subcommittee on Cell and Gene Therapy Products Produced in vivo
-
October 5, 2023
Review
List of Approved Products: FY2022 (April 2022 to March 2023) and FY2023 (April 2023 to June 2023)
-
September 26, 2023
Review
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
-
September 26, 2023
Review
GMP compliance inspection
-
September 11, 2023
Sci board
The 2nd Subcommittee on Cell and Gene Therapy Products Produced in vivo
-
September 7, 2023
Pub cmt
JP Drafts (September 2023) posted
-
August 29, 2023
Sci board
The 1st Subcommittee on Cell and Gene Therapy Products Produced in vivo
-
August 28, 2023
Sci board
The 6th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
-
August 9, 2023
Review
The information of Regulatory Science Consultations updated
-
August 4, 2023
Sci board
The 46th Science Board Meeting
-
July 27, 2023
Safety
PMDA Alert for Proper Use of Drugs: Appropriate Measures to Be Taken for Pemphigoid Due to Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, posted
-
June 30, 2023
JP
JP 18th Edition Supplement I (English version) posted
-
June 20, 2023
Events
PMDA-ATC Pharmaceuticals Review Webinar 2023
-
May 26, 2023
Int
Cooperation between WHO and PMDA on training for regulatory authorities
-
May 17, 2023
Sci board
The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
-
May 9, 2023
Review
Regenerative Medical Products Information posted
-
May 9, 2023
Review
Regulations Regarding Living Modified Organisms (Genetically Modified Organisms) posted
-
April 11, 2023
Sci board
The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning