Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

October 2, 2025

Review

New

Concept of New Approach Methodologies (NAMs) use in quasi-drug applications (Early Consideration) and Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker (Early consideration) posted
October 1, 2025

Int

New

New PMDA-ATC E-learning content has been released on the Pmda Channel
September 30, 2025

Review

New

List of Approved CDx（Companion Diagnostics）: Updated Sep 19, 2025
September 30, 2025

Int

PMDA Washington D.C. Office Map Refreshed
September 30, 2025

Other

New

Recent Publications by PMDA Staff updated
September 29, 2025

Review

New

English Translation of Review Report: Datroway
September 26, 2025

Events

New

PMDA-ATC Pharmaceuticals Review Webinar 2025 applications open
September 26, 2025

Events

New

PMDA-ATC MRCT/GCP Inspection Seminar 2026 applications open
September 19, 2025

Safety

PMDA Risk Communications: Lubiprostone, etc. posted
September 18, 2025

Safety

PMDA Alert for Proper Use of Drugs: No. 7 Compliance with Measurement of Blood Lithium Levels during Treatment with Lithium Carbonate (revision) posted

Back number

Currently, there is no applicable information.

Back number

September 30, 2025

Other

New

Recent Publications by PMDA Staff updated

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.