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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