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June 24, 2025
Safety
New
Revisions of PRECAUTIONS: Thiamazole, etc. posted
June 20, 2025
Other
Recent Publications by PMDA Staff updated
June 18, 2025
Review
English Translation of Review Report: Fabhalta
June 17, 2025
MHLW Pharmaceuticals and Medical Devices Safety Information No.420 posted
Drug
IVD
All
Currently, there is no applicable information.
Clinical trials, reviews, consultations, compliance assessments, and inspections concerning applications for drugs, medical devices, regenerative medical products, etc.
Collection and provision of information regarding post-marketing safety and scientific research and analyses on data collected.
Relief Systems for Adverse Drug Reactions.
Regulatory science research, the Science Board, projects across multi-offices in PMDA, and standards development (e.g., Japanese Pharmacopoeia, medical device standards).
International harmonization activities such as collaboration with overseas regulatory authorities and international organizations, participation in international meetings including ICH, and activities related to Asia Training Center.