Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

May 29, 2026

Review

New

English translation of review report: Coseal
May 28, 2026

Review

New

Four English-language Early Considerations have been published, including those on biosimilars, in vivo diagnostics, and vaccines.
May 27, 2026

JP

New

Schedule of JP19-I Publication posted
May 26, 2026

Review

New

English Translation of Review Report: Elevidys and Vyjuvek Gel
May 26, 2026

Review

New

English Translation of Review Report: Livmarli and mRESVIA
May 25, 2026

Review

New

Software as a Medical Device (SaMD) page updated
May 25, 2026

Int

New

Registration for the ASEAN-Japan Medical Devices Regulatory Symposium is now open.
May 22, 2026

Review

The new website “Overview of Orphan Drug Designation“ launched.
May 22, 2026

Review

The new website “Designation / Early Access“ launched.
May 20, 2026

Review

List of therapeutic products for which eligible patients can be identified by Drug-Agnostic CDx,posted
May 19, 2026

Safety

PMDA Risk Communications: Ferric carboxymaltose etc. posted
May 19, 2026

JP

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

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May 19, 2026

Drug

IVD

PMDA Risk Communications: Ferric carboxymaltose etc. posted

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Currently, there is no applicable information.

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May 25, 2026

All

New

Registration for the ASEAN-Japan Medical Devices Regulatory Symposium is now open.

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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.