“Basic Principles on Global Clinical Trials” (PFSB/ELD Notification No. 0928010, Director of the Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, dated September 28, 2007) had been issued based on the knowledge accumulated through the clinical trial consultations of Pharmaceuticals and Medical Devices Agency.

Based on the outcome of cooperation in clinical trials among the regulatory authorities of Japan, China, and South Korea from 2007 as well as knowledge
accumulated after the issuance of the above Notification, “Basic Principles on Global Clinical Trials (Reference Cases)” has been compiled as attached.