The Taiwan Food and Drug Administration has issued the draft of a Cell and Gene Therapy Product Management Act” which defines cell and gene therapy products, regulates the suitability of donors, and regulates security conditions. The draft is expected to be sent to the Executive Yuan by the end of the year. Before listing, cell and gene therapy products must pass three clinical trials and an audit, but under urgent circumstances (risk of life) a temporary license can be issued. “

China Bio news release, August 14, 2017