Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

June 5, 2026

Safety

New

Revisions of PRECAUTIONS: Donanemab(genetical recombination) , etc. posted
June 5, 2026

Review

New

Software as a Medical Device (SaMD) page updated
June 4, 2026

Review

New

English Translation of Review Report: Doptelet (Partial Change Approval)
June 4, 2026

Events

New

Report on the PMDA-ATC 10th Anniversary Ceremony has been posted.
June 4, 2026

Review

New

English-language Early Considerations 'Considerations for the General Toxicity Evaluation of Monoclonal Antibodies （Early Consideration）' has been published.
June 1, 2026

Events

New

Symposium for the 10 anniversary of the PMDA Hokuriku Branch
May 29, 2026

Review

English translation of review report: Coseal
May 27, 2026

JP

Schedule of JP19-I Publication posted
May 26, 2026

Review

English Translation of Review Report: Elevidys and Vyjuvek Gel
May 25, 2026

Int

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

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June 5, 2026

Drug

IVD

New

Revisions of PRECAUTIONS: Donanemab(genetical recombination) , etc. posted

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Currently, there is no applicable information.

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May 27, 2026

JP

Schedule of JP19-I Publication posted

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May 25, 2026

All

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.