2014 Volume 4 Issue 3 Pages 223-230
The new regulation of the conditional and time-limited approval system considering of the characteristics of regenerative medicinal products and the Package Insert notification to the authority, are deeply associated with clinical drug development in the revision of the Pharmaceutical Affairs Law announced in November 2013 (enforcement of the revision scheduled in November 2014). The Act of safe security for regenerative medicine will be simultaneously enforced with this revision. “The correct risk assessment and the appropriate response based of the magnitude of the risk” from research and development stage until implementation as medical practice is inferred as the fundamental concepts. However, different clinical study regulation systems can be applied to the clinical study standard in Japan between regenerative medicine and other medicinal products/medical devices, and also between clinical trials for Japanese new drug application and other clinical studies, so that it would not be preferable for the properly understanding and its excellent regulation on the Act for all stakeholders. The rigid regulation systems should be hopefully established, which can be commonly used for those, with national standards for medicinal management and clinical study conduct, which would be affected on life and health of human kinds.
