Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

July 16, 2026

Review

New

English Translation of Review Report: Vorzzz
July 14, 2026

Safety

New

PMDA Risk Communications: Domperidone (oral preparations) etc. posted
July 14, 2026

Safety

New

Revisions of PRECAUTIONS: Esomeprazole Magnesium Hydrate, etc. posted
July 13, 2026

JP

New

Press Release regarding international activities related to Pharmacopoeia posted
July 13, 2026

Review

New

Checklist for Quality-Related Documents for Biotechnology Products Derived from Cell Lines of Human or Animal Origin at the Time of Initial Clinical Trial Notification（Early Consideration）posted.
July 10, 2026

Review

New

English Translation of Review Report: AMCHEPRY
July 10, 2026

Int

New

PMDA Updates (2026 No.2) posted
July 7, 2026

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.429 posted
July 7, 2026

Other

PMDA Concludes a Memorandum of Understanding with the London School of Hygiene & Tropical Medicine (LSHTM) (News Release) (July 6, 2026) [222KB]
July 6, 2026

Review

Software as a Medical Device (SaMD) page updated

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Currently, there is no applicable information.

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July 13, 2026

JP

New

Press Release regarding international activities related to Pharmacopoeia posted

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July 10, 2026

All

New

PMDA Updates (2026 No.2) posted

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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.