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March 27, 2023
Safety
Revisions of PRECAUTIONS:Anti-human thymocyte immunoglobulin, rabbit posted
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March 14, 2023
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.399
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March 9, 2023
Events
PMDA-ATC & U.S. FDA Pediatric Review Seminar 2023
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March 7, 2023
Pub cmt
JP Drafts (March 2023) No.1 posted
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March 7, 2023
Pub cmt
JP Drafts (March 2023) No.2 posted
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February 27, 2023
Other
The 44th Science Board Meeting
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February 20, 2023
Other
The 3rd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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January 25, 2023
Review
Ministerial Ordinance on Good Clinical Practice for Drugs updated
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January 17, 2023
Other
The 45th Science Board Meeting
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December 28, 2022
JP
Schedule of JP18-II Publication posted
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December 21, 2022
Other
The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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December 16, 2022
Events
The 9th Thailand-Japan Symposium
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December 8, 2022
Events
The 4th ICH Forum: ICH Efficacy Guideline Update
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December 7, 2022
Pub cmt
JP Drafts (December 2022) posted
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November 30, 2022
Other
The 2nd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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November 15, 2022
Events
The 3rd Vietnam-Japan Symposium
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November 15, 2022
Other
The 6th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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October 31, 2022
Events
PMDA-ATC Pharmacovigilance Webinar 2023
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October 21, 2022
Int
A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines
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October 14, 2022
Events
PMDA-ATC with National Cancer Center MRCT Webinar 2023
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September 30, 2022
Events
PMDA-ATC/AMDC Medical Devices Webinar 2022
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September 12, 2022
Int
PMDA-ATC digital book is now available.
-
September 6, 2022
Events
PMDA-ATC Pharmaceuticals Review Webinar 2022
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August 22, 2022
Other
The 5th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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August 8, 2022
Events
APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022
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August 2, 2022
Other
The 43rd Science Board Meeting
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July 29, 2022
Safety
Risk Management Plan (RMP) ：RMP Page renewal, Questions and Answers (Qs and As) on Risk Management Plan, Risk Management Plan templates, instructions and publication posted
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July 19, 2022
Other
Dr. Yasuhiro Fujiwara, Chief Executive of PMDA, re-elected Vice Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) (News Release) (July 19, 2022) [489.83KB]
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July 19, 2022
Events
PMDA-ATC GMP Inspection Webinar 2022
-
June 13, 2022
Events
The 2nd Malaysia-Japan Symposium
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June 6, 2022
Events
PMDA-ATC & U.S. FDA Pediatric Review Webinar 2022
-
May 27, 2022
Int
Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
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May 17, 2022
Events
PMDA-ATC Quality Control (Herbal Medicine) Webinar 2022
-
April 11, 2022
Other
The 4th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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