Here begins the text.
What's New (FY2022)
March 30, 2023PMDA Medical Safety Informations: Precautions for Handling of Sustained-Release Preparations posted
March 27, 2023Revisions of PRECAUTIONS:Anti-human thymocyte immunoglobulin, rabbit posted
March 14, 2023MHLW Pharmaceuticals and Medical Devices Safety Information No.399
March 7, 2023JP Drafts (March 2023) No.1 posted
March 7, 2023JP Drafts (March 2023) No.2 posted
February 28, 2023PDG October 2022 Videoconference Meeting Highlights posted
February 27, 2023The 44th Science Board Meeting
February 20, 2023The 3rd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
February 9, 2023Notifications Related to Safety Measures (In-vitro Diagnostics) : Consultation associated with Revision, etc. of Package Inserts, etc. for in vitro Diagnostics posted
January 25, 2023Ministerial Ordinance on Good Clinical Practice for Drugs updated
January 20, 2023Notifications Related to Safety Measures (Medical Devices) : Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc. posted
January 20, 2023Notifications Related to Safety Measures (Drugs): Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc. posted
January 17, 2023The 45th Science Board Meeting
December 16, 2022The 9th Thailand-Japan Symposium
December 8, 2022The 4th ICH Forum: ICH Efficacy Guideline Update
December 7, 2022JP Drafts (December 2022) posted
November 30, 2022The 2nd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
November 15, 2022The 3rd Vietnam-Japan Symposium
November 15, 2022The 6th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
October 31, 2022PMDA-ATC Pharmacovigilance Webinar 2023
October 21, 2022A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines
October 14, 2022PMDA-ATC with National Cancer Center MRCT Webinar 2023
October 4, 2022Profile of Services posted
September 30, 2022PMDA-ATC/AMDC Medical Devices Webinar 2022
September 28, 2022The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
September 6, 2022PMDA-ATC Pharmaceuticals Review Webinar 2022
August 23, 2022ICMRA (International Coalition of Medicines Regulatory Authorities)
August 22, 2022The 5th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
August 19, 2022List of Approved Products: FY2021 (April 2021 - March 2022)
August 8, 2022APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022
August 2, 2022The 43rd Science Board Meeting
July 29, 2022Risk Management Plan (RMP) :RMP Page renewal, Questions and Answers (Qs and As) on Risk Management Plan, Risk Management Plan templates, instructions and publication posted
July 19, 2022Dr. Yasuhiro Fujiwara, Chief Executive of PMDA, re-elected Vice Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) (News Release) (July 19, 2022)
June 13, 2022The 2nd Malaysia-Japan Symposium
June 2, 2022 English Translated Package Inserts page now available. Gadoteridol posted.
May 27, 2022Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
April 11, 2022The 4th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes