Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

May 20, 2025

Safety

New

Revisions of PRECAUTIONS: Onasemnogene abeparvovec posted
May 20, 2025

Safety

New

Revisions of PRECAUTIONS: Acetazolamide, etc. posted
May 20, 2025

Review

New

List of Approved CDx（Companion Diagnostics）: Updated May 14, 2025
May 19, 2025

JP

New

PDG March 2025 Videoconference Press Release posted
May 19, 2025

Review

New

Points to consider for externally controlled trials (Early Consideration) posted
May 16, 2025

Events

New

PMDA-ATC GMP Inspection Seminar 2025
May 15, 2025

Safety

New

MHLW Pharmaceuticals and Medical Devices Safety Information No.419 posted
May 14, 2025

JP

New

Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
May 14, 2025

Int

Call for PMDA-ATC GMP Inspection Seminar 2025
May 14, 2025

Other

Recent Publications by PMDA Staff updated
May 8, 2025

Review

English Translation of Review Report: Jaypirca

Back number

Currently, there is no applicable information.

Back number

May 14, 2025

Drug

Devices

Call for PMDA-ATC GMP Inspection Seminar 2025

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.