An accelerated approval process for regenerative medicine products is unique to Japan. In this process, when efficacy can be presumed and safety is confirmed for a regenerative medicine based on processed human cells, the product can be approved earlier than would be possible for conventional medicines, subject to certain terms and conditions. This allows regenerative medicine products to be approved earlier in Japan than in any other countries.
Japan's Revised Pharmaceutical Affairs Act authorized this system, and became effective in November 2014.
