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