Japan drug regulatory process

The Japanese regulatory process was revised in 2004, creating the Pharmaceutical and Medical Devices Agency (PMDA), and provisions relating to medical devices came into effect on April 1, 2005 [16], In Japan two submissions may be required a KIT Drug J-NDA submission and a separate Medical Device Certification the latter of these has to be filed with PMDA. It should be noted that the review timelines for KIT Drug and Medical Device Certification submissions... 

Russell KB, Bremer M. New Drug Approval in Japan. Waltham, MA PAREXEL International, 2002. The authors provide a thorough analysis of Japan s reorganized regulatory agency structure, its streamlined NDA process, and its rapidly evolving policies toward the acceptance of foreign clinical data. 

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