Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan

Posted 23 March 2017 By Satoshi Koike, PhD, DSc

placeholder+image 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.

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Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, Submission and registration, Features, Japan, MHLW, PMDA

Tags: Common Technical Document, CTD

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