Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

October 22, 2026

Review

New

English Translation of Review Report: Capvaxive and Ekterly
October 19, 2026

Review

New

Points to Consider for the Development of Companion Diagnostics Developed in Parallel with Anti-cancer Drugs(Early Consideration) and Quality-Related Considerations for Human Cell-Derived Extracellular Vesicle (EV) Products at the Time of Initial Clinical Trial Notification (Early Consideration) posted.
October 14, 2026

Review

SaMD page updated (English translation of “Review Points for Medical Devices Utilizing Generative AI (Draft)” published, consultation schedule updated)
October 14, 2026

Review

Information on biosimilars is updated
October 13, 2026

JP

Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
October 8, 2026

Safety

Revisions of PRECAUTIONS: Anamorelin hydrochloride,etc.posted

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October 8, 2026

Drug

IVD

Revisions of PRECAUTIONS: Anamorelin hydrochloride,etc.posted

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Currently, there is no applicable information.

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October 13, 2026

JP

Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated

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Currently, there is no applicable information.

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Services of PMDA

Reviews and Related Services

Clinical trials, reviews, consultations, compliance assessments, and inspections concerning applications for drugs, medical devices, regenerative medical products, etc.

Post-marketing Safety Measures

Collection and provision of information regarding post-marketing safety and scientific research and analyses on data collected.

Relief Services for Adverse Health Effects

Relief Systems for Adverse Drug Reactions.

Regulatory Science

Regulatory science research, the Science Board, projects across multi-offices in PMDA, and standards development (e.g., Japanese Pharmacopoeia, medical device standards).

International Activities

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.