Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

September 5, 2025

Review

New

GMP / GCTP Annual Report FY 2024 posted
September 4, 2025

Events

New

Report of the PMDA-ATC Review of CGTP products Seminar 2025 for South-East Asian Countries
September 4, 2025

Other

New

Recent Publications by PMDA Staff updated
September 2, 2025

Review

New

English translation of review report: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
September 1, 2025

JP

New

PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (September 2025) posted
August 29, 2025

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.422 posted
August 28, 2025

Safety

Revisions of PRECAUTIONS: Delandistrogene moxeparvovec posted
August 26, 2025

Review

List of Approved CDx（Companion Diagnostics）: Updated Aug 20, 2025
August 25, 2025

JP

PDG Revision of Q-09 Particulate contamination News 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.