This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities. Introduction With the support of the Japanese Ministry...

This article focuses on PMDA consultations for drug development. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) was established by the Ministry of Health, Labour, and Welfare (MHLW) in 2004. In addition to scientific reviews and conformity audits of marketing authorization applications for drugs and medical devices, PMDA provides various types of consultations, from pharmaceutical affairs on research and development strategy to clinical trials. It is valuabl...