Reply to Suggestion No. 6238
of the First Session of the 13th National People's Congress
Honorable Deputy:
We have received your suggestion on rapidly advancing the clinical translational application of cell-based immunotherapy. After consultation with the National Medical Products Administration, our reply is as follows:
Cell therapy is one of the important development directions of medicine in the future, and our Commission attaches great importance to it. Together with the National Medical Products Administration, we are actively advancing relevant work.
1. On further improving the management system for immune cell therapy
To further standardize and promote the development of somatic cell therapy, our Commission, together with the National Medical Products Administration, is studying and formulating administrative measures for the clinical research and translational application of somatic cell therapy, and plans to release them for public consultation in the near future. In the formulation process, drawing on the experience of the filing system for stem cell clinical research, somatic cell therapies developed and prepared by medical institutions themselves and conducted within those institutions will be managed accordingly. At the same time, fully incorporating the views of relevant experts, somatic cell preparations produced as drugs will, in accordance with the Technical Guidelines for Research and Evaluation of Cell Products (Trial) issued by the former China Food and Drug Administration in 2017, apply for clinical trials and marketing authorization.
2. On strengthening support for cell therapy R&D and clearing the path for products
Under the project plans of the Major National Science and Technology Projects "Major New Drug Creation" and "Prevention and Treatment of Major Infectious Diseases such as AIDS and Viral Hepatitis", our Commission has supported multiple pharmaceutical enterprises and research institutions in conducting research on multiple CAR-T technology candidates targeting lung cancer, liver cancer, multiple myeloma, and others. About 41.4 million yuan in central fiscal funding has been invested in total to support the cultivation and development of relevant innovation teams. The 2018 project plan of the New Drug Special Project has already incorporated multiple CAR-T research projects through open competitive selection. Several of the more rapidly progressing and stronger domestic enterprises will receive funding. To open up paths for cell therapy-related research and products, at the end of 2017 our Commission, together with the former China Food and Drug Administration, issued the Technical Guidelines for Research and Evaluation of Cell Products (Trial), restarting the research and registration of cell therapy products and setting out detailed requirements for cell therapy products intended to be productized and industrialized as drugs. Products meeting the relevant requirements may be marketed. More than 10 cell therapy products will soon be approved for clinical trials.
3. On enhancing technical review capacity for innovative biologics such as immune cell therapy
In the 2018 project plan of the National Major Science and Technology Project "Major New Drug Creation", our Commission has commissioned the National Institutes for Food and Drug Control to undertake a directed project, "Key Technology Research on Evaluation and Standardization of Innovative Biotechnology Drugs", so as to establish, as soon as possible, a scientific evaluation system for relevant innovative biotechnology drugs, thereby resolving technical bottlenecks in review and supporting evaluation and standardization research on innovative biotechnology drugs such as cell and gene therapies, and paving the way for managing immune cell therapies and other preparations with drug attributes as drugs.
Your suggestion is of great significance to advancing the development of cell therapy in China. We will study and incorporate it carefully and actively advance the work mentioned above.
Thank you for your concern for and support of health work.
National Health Commission
