A New Regulatory System for Stem Cell–Based Therapies in Japan
Posted on June 3, 2014
The Japanese government has implemented a novel regulatory framework for stem cell based therapies: The Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law. Recognizing that the conventional regulatory framework for pharmaceuticals is unsuitable for cell based regenerative therapies, delaying and even prohibiting their development. The Japanese regulation attempts to balance the need for expedited provision of innovative therapies and appropriate steps to ensure safety and efficacy. Details and background information about the Japanese regulation are outlined in two recent articles here and here.