China’s National Medical Products Administration (NMPA) has proposed draft measures to speed up reviews of cell and gene therapies. It is taking public comments for one month. The plan covers products for cancers, rare diseases, immune disorders, neurodegenerative conditions, and genetic disorders. This is the first time the agency has built a review track specifically for this therapy class. The move follows the “Tech Track,” a separate pathway the National Health Commission launched two months ago for novel biomedical technologies.
The draft responds to long-standing complaints from developers and manufacturers: unpredictable Investigational New Drug (IND) review timelines, slow turnaround on supplemental filings, and limited communication with regulators. Under the new framework, products with strong clinical potential could get a 30-day IND review window and priority fast-track status. Supplemental applications tied to manufacturing changes would see the review timeframe cut from 200 working days to 130 working days. Companies could also request expedited meetings with China’s drug review center, guaranteed within 30 days.
This is widely seen as an attempt to draw multinational drugmakers into running early-stage trials in China. Alongside the proposal, the NMPA also issued two new technical guidelines spelling out how cell and gene therapies should be defined and classified.
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.