Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

September 10, 2026

Review

New

English Translation of Review Report: remedē System
September 9, 2026

Events

New

Report on the PMDA Hokuriku Branch 10th Anniversary Symposium
September 8, 2026

Pub cmt

New

JP Drafts (September 2026) Part 1 posted
September 8, 2026

Pub cmt

New

JP Drafts (September 2026) Part 2 posted
September 3, 2026

Review

English Translation of Review Report: Akuugo (Partial Change Approval)
September 3, 2026

Review

Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.
September 1, 2026

Int

PMDA-ATC Training Materials have been updated
August 31, 2026

Review

Available schedule for consultation by the Office of Software as a Medical Device updated
August 31, 2026

Events

Report of PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026

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Currently, there is no applicable information.

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Currently, there is no applicable information.

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September 1, 2026

All

PMDA-ATC Training Materials have been updated

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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.