Japan: PMDA Provides Updated Guidance on Conducting Global Clinical Trials

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has issued a newly-updated Q&A document that revises its 2007 guidance on conducting international clinical trials.  

PMDA recommends that companies use the document, Basic Principles on Global Clinical Trials (Reference Cases), prior to engaging the agency in consultations on proposed clinical trials.

In its notice, PMDA explains that the document reflects the experience the agency has gained since 2007 with its involvement, "In global clinical trials at an early stage of drug development and large-scale global clinical trials." The agency also cited the experience gained through regulatory cooperation activities with China's State Food and Drug Administration (SFDA), South Korea's Food and Drug Administration (KFDA), the European Medicines Agency (EMA) and the US Food and Drug Administration (USFDA).