Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

February 16, 2026

Review

New

English Translation of Review Report: Spikevax (Partial Change Approval)
February 16, 2026

Safety

New

PMDA Medical Safety Information: Precautions for Handling of Gastrostomy Catheters（No.72） posted
February 16, 2026

Other

New

Recent Publications by PMDA Staff updated
February 12, 2026

Review

New

One-Stop Service Platform by ENSEMBLExJ page created
February 10, 2026

Safety

MHLW Pharmaceuticals and Medical Devices Safety Information No.426 posted
February 10, 2026

Safety

Revisions of PRECAUTIONS: Cytarabine , etc. posted
February 6, 2026

JP

PDG October 2025 Meeting Highlights posted
February 6, 2026

Int

PMDA Updates (2026 No.1) posted
February 5, 2026

Review

Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation (Early Consideration), Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals (Early Consideration),Consideration in the development of drugs for hypertrophic cardiomyopathy (Early Consideration) posted
February 4, 2026

Safety

English Translated Package Inserts page: Ensure Liquid updated
February 4, 2026

Review

List of Approved Medical Devices: April 2004 to June 2025

Back number

Currently, there is no applicable information.

Back number

February 6, 2026

All

PMDA Updates (2026 No.1) 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.