To pilot national systems on a broader scale and with more coordinated resources, fully leverage innovation platforms, and empower industrial innovation and development, the Tianjin Free Trade Zone Administrative Committee has officially approved the establishment of the China (Tianjin) Pilot Free Trade Zone Linkage Innovation Demonstration Base at the National Stem Cell Engineering Product Industrialization Base.
Relying on the closed-loop management environment of the National Stem Cell Engineering Product Industrialization Base — which covers cell storage, R&D, production and preparation, and clinical translational application — and benchmarking against international common practices and standards, the China (Tianjin) Pilot Free Trade Zone Linkage Innovation Demonstration Base will, under conditions of effective risk prevention and control, organize pilots of clinical translational application of cell therapy, piloting systems and standards for the country, creating benefits and prospects for patients, and expanding development space for the industry.
On the basis of thorough deliberation and risk control, it will boldly explore, boldly pilot, and independently reform. It will promote the formation of technical specifications or standards in cell collection, production and preparation, transportation, quality control, in-hospital release, risk control, and other areas; achieve a number of institutional innovations in tiered and classified management of cell therapy, the review and approval system, and the in-process and post-event supervision system; explore breakthroughs in compassionate use of investigational drugs in cell therapy clinical trials, the import of drugs and medical devices already marketed abroad but not yet in China, and charging clinical applications of cell therapy as licensed medical technologies; and form a body of replicable and scalable pilot experience that lays a solid foundation for further expansion of the pilot scope.
News source: Administrative Committee of China (Tianjin) Pilot Free Trade Zone
