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

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

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Regulatory Information・Early Consideration
Multi-Regional Clinical Trials

Reviews and Related Services

Multi-Regional Clinical Trials

日本語ページはこちら

Links to major regulatory information of Multi-Regional Clinical Trials.

Regulations and Notifications

Basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan[244.40KB]

December 25, 2023 PSB/PED Notification No. 1225-2

Q&A for basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan[119.18KB]

December 25, 2023 PSB/PED Administrative Notice

Amendment to “Basic Principles on Global Clinical Trials (Reference Cases)”[431.73KB]

December 10, 2021 PSEHB/PED Administrative Notice

Basic Principles on Global Clinical Trials (Reference Cases)[89.69KB]

September 5, 2012 PFSB/ELD Administrative Notice

Basic Principles on Global Clinical Trials[188.76KB]

September 28, 2007 PFSB/ELD Notification No. 0928010