Multi-Regional Clinical Trials

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