Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

December 4, 2025

Other

New

Recent Publications by PMDA Staff updated
December 3, 2025

Review

New

Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development Stage（Early Consideration）posted
November 28, 2025

Review

New

Regulatory Information updated
November 28, 2025

Review

New

Quasi-Drugs page created
November 28, 2025

Review

New

Review Reports : Quasi-Drugs page created
November 28, 2025

Review

New

Others updated
November 26, 2025

Safety

Revisions of PRECAUTIONS: Onasemnogene abeparvovec posted
November 26, 2025

Safety

Revisions of PRECAUTIONS: Bosentan hydrate, etc. posted
November 26, 2025

Review

List of Approved CDx（Companion Diagnostics）: Updated Nov 20, 2025
November 26, 2025

Review

English Translation of Review Report: Andembry and Nuvaxovid (Partial Change Approval)
November 25, 2025

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.424 posted
November 20, 2025

Review

English translation of review report: CureApp AUD A Digital Therapeutic to Reduce Alcohol Consumption

Back number

Currently, there is no applicable information.

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December 4, 2025

Other

New

Recent Publications by PMDA Staff updated

Back number

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.