China is doing exceedingly well in developing new drugs and biotech products. About one-third of global MNC licensing deals are now with Chinese drugs in development. One of the reasons for China’s success is a large pool of science talent and the ability to initiate China clinical trials quicker than in the West. This month, China’s NMPA has drafted a policy to further expedite new drug development in stating they want to reduce the clinical trial review time in China from 60 working days down to 30 working days. In this new draft policy, if the new drug has strong clinical value, is for a rare disease or pediatric use, or is part of a global study, the timeframe suggested will be 30 days. Public feedback on this new timeframe is due by July 16.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.