Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

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

New

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
July 1, 2026

Review

English Translation of Review Report: Fujichenon
July 1, 2026

Other

Conclusion of a Memorandum of Understanding between the Medical University of Vienna and the Pharmaceuticals and Medical Devices Agency (PMDA) (News Release) (June 30, 2026) [263KB]
June 30, 2026

Safety

Revisions of PRECAUTIONS: Cefcapene Pivoxil Hydrochloride Hydrate, etc. posted
June 30, 2026

Safety

PMDA Alert for Proper Use of Drugs: Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group (follow-up report) posted
June 30, 2026

Review

English Translation of Review Report: SUSMED App for Insomnia Medcle (Partial Change Approval)

Back number

Currently, there is no applicable information.

Back number

July 13, 2026

JP

New

Press Release regarding international activities related to Pharmacopoeia posted

Back number

July 10, 2026

All

New

PMDA Updates (2026 No.2) posted

Back number

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.