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Safety Alert & Recalls/ Review Reports/ Package Inserts etc.

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About PMDA

About PMDA

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Safety Alert & Recalls/ Review Reports/ Package Inserts etc.

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Reviews and Related Services
Regulatory Information・Early Consideration
Clinical Trials

Reviews and Related Services

Clinical Trials

Links to major regulatory information of Clinical Trials.

Regulations and Notifications

Japanese Compassionate Use System

Clinical Trials Conducted on Ethical Grounds-Japanese Compassionate Use System-[392.52KB]

January 22, 2016 PSEHB/ELD Notification No. 0122-7

First in Human Studies

English Translations of the Guidance for Establishing Safety in First-in-Human Studies during Drug Development and its Questions and Answers[263.18KB]

April 18, 2012 PFSB/ELD Administrative Notice

Clinical Trial Notification Review

Example of Documents on Assessment and Control of DNA Reactive (Mutagenic) Impurities attached to Clinical Trial Notification (Early Consideration)[399KB]

January 16, 2025 Administrative Notice

Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)[241KB]

December 10, 2024

Frequently Asked Questions (FAQ)

Clinical trials