The policy is introduced! Tianjin Free Trade Zone’s gene and cell therapy clinical transformation application pilot was approved!

In order to test the system on a larger scale and coordinate more resources for the country, give full play to the role of the innovation platform, and empower industrial innovation and development, baseline;”>Tianjin Pilot Free Trade Zone Management Committee officially approved the construction of China (Tianjin) Pilot Free Trade Zone Linkage Innovation Demonstration Base at the National Stem Cell Engineering Products Industrialization Base.

The China (Tianjin) Pilot Free Trade Zone Linkage Innovation Demonstration Base will rely on the fully closed-loop management environment of cell storage, research and development, production and preparation, clinical transformation and application of the national stem cell engineering product industrialization base, and benchmark against internationally accepted practices and standards. font-size: inherit; line-height: inherit; font-family: inherit; vertical-align: baseline;”>Organize and carry out pilot clinical transformation applications of cell therapy under the conditions of effective risk prevention and control, test systems and standards for the country, create welfare and growth opportunities for patients, and seek development and space for the industry.

On the basis of full demonstration and risk prevention and control, boldly venture into, boldly try, and make independent changes. Promote the formation of a number of technical specifications or standards in cell collection, production and preparation, transportation, quality control, hospital release, risk control, etc.; form a number of institutional innovations in cell therapy hierarchical and classified management systems, review and approval systems, and interim and post-event supervision systems; explore compassionate use in cell therapy clinical trials, imported drugs and medical devices that have been marketed abroad and have not been marketed in China, Cell therapy has achieved breakthroughs in aspects such as clinical charging and application in accordance with medical technology access; a number of pilot experiences that can be replicated and promoted have been formed, laying a solid foundation for further expanding the scope of the pilot.

News source: China (Tianjin) Pilot Free Trade Zone Management Committee