Pharmaceuticals and Medical Devices Agency

Events and Symposia

Public comments

What's new

April 14, 2026

Review

New

The information of New Drug Review with Electronic Data updated
April 13, 2026

Events

New

The report for the PMDA-ATC Pharmacovigilance Seminar 2026 has been posted.
April 13, 2026

Int

New

The report for the APEC CoE workshop: PMDA-ATC Pharacovigilance Seminar 2026 has been posted.
April 13, 2026

Int

New

PMDA-ATC E-Learning Course contents have been released for FY2026
April 13, 2026

Other

New

Recent Publications by PMDA Staff updated
April 10, 2026

Review

New

Considerations for clinical development of intravenous formulations containing the same active ingredient as oral products for patients who are temporarily unable to receive oral administration in epilepsy treatment （Early consideration） posted
April 8, 2026

Review

New

The English versions of Orange Letter No.10~12 have been published.
April 6, 2026

Review

Software as a Medical Device (SaMD) page updated
April 6, 2026

Review

Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
April 6, 2026

Review

List of Approved Drugs: April 2004 to September 2025
April 6, 2026

Events

PMDA-ATC Generic Drugs Review Seminar 2026 applications open
April 3, 2026

Review

English translation of review report: Peripheral Rotablator PRO and Visual-ICE Cryoablation System (Partial Change Approval)

Back number

Currently, there is no applicable information.

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Currently, there is no applicable information.

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April 13, 2026

Other

New

Recent Publications by PMDA Staff 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.