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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
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March 19, 2024
Events
Call for PMDA-ATC & U.S. FDA Pediatric Review Seminar 2024 has been opened.
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March 14, 2024
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.408
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March 12, 2024
Events
PMDA-ATC Pharmaceuticals Review Seminar 2024 for PPWG member states
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March 7, 2024
Pub cmt
JP Drafts (March 2024) posted
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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
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December 27, 2023
Safety
English Translated Package Inserts page: Ensure Liquid updated
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December 8, 2023
Events
The 10th Thailand-Japan Symposium
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December 7, 2023
Pub cmt
JP Drafts (December 2023) posted
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December 7, 2023
Other
The 4th Subcommittee on Cell and Gene Therapy Products Produced in vivo
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December 6, 2023
Other
【Warning】Please Be Aware of Phishing E-mails Pretending to be from the PMDA (December 6, 2023)
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November 20, 2023
Events
PMDA-ATC Pharmacovigilance Webinar 2024
-
November 17, 2023
Events
The 4th Vietnam-Japan Symposium
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October 31, 2023
Events
PMDA-ATC GMP Inspection Webinar 2024
-
October 17, 2023
Events
PMDA-ATC/AMDC Medical Devices Webinar 2023
-
October 12, 2023
Int
ICMRA statement on the safety of COVID-19 vaccines
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October 6, 2023
JP
JP Frequently Asked Questions Q11~Q13 updated
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October 6, 2023
Other
The 3rd Subcommittee on Cell and Gene Therapy Products Produced in vivo
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September 26, 2023
Review
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
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September 11, 2023
Other
The 2nd Subcommittee on Cell and Gene Therapy Products Produced in vivo
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September 7, 2023
Pub cmt
JP Drafts (September 2023) posted
-
August 29, 2023
Other
The 1st Subcommittee on Cell and Gene Therapy Products Produced in vivo
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August 28, 2023
Other
The 6th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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August 25, 2023
Events
Application for APEC CoE Workshop PMDA-ATC Medical Devices Workshop 2023 has been opened.
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August 4, 2023
Other
The 46th Science Board Meeting
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June 20, 2023
Events
PMDA-ATC Pharmaceuticals Review Webinar 2023
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May 26, 2023
Int
Cooperation between WHO and PMDA on training for regulatory authorities
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May 17, 2023
Other
The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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May 9, 2023
Review
Regulations Regarding Living Modified Organisms (Genetically Modified Organisms) posted
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April 19, 2023
Events
PMDA-ATC Quality Control (Herbal Medicine) Seminar 2023
-
April 11, 2023
Other
The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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