Editor's note: Recently, the National Health Commission responded to Recommendation No. 6238 of the First Session of the 13th National People's Congress. The reply stated that the National Health and Health Commission will actively promote the related work of cell therapy with the drug regulatory department. The reply also mentioned that “more than 10 cell therapy products will be approved for clinical trials in the near future.” The full text is as follows:
A meeting of the 13th National People's Congress
Reply No. 6238
Your suggestions on rapidly advancing the clinical application of cellular immunotherapy are received. With the State Administration of Drug Administration in business, the reply is as follows:
Cell therapy is one of the important development directions in the future medical field. Our Committee attaches great importance to this, and actively promotes related work together with the State Drug Administration.
1. About further improving the immune cell therapy management system
In order to further standardize and promote the development of somatic cell therapy, our committee is working with the State Food and Drug Administration to formulate management methods for the clinical research and translational application of somatic cell therapy, and plans to solicit opinions from the society in the near future. In the formulation process, drawing on the experience of record management of stem cell clinical research, the management of somatic cell therapy developed and prepared by the medical institution itself and carried out in the medical institution is managed. At the same time, fully absorb the opinions of relevant experts, and apply for clinical trials and marketing permission for somatic cell preparations produced according to pharmaceuticals in accordance with the "Guidance Principles for the Research and Evaluation of Cell Products (Technical Guidelines)" issued by the former National Food and Drug Administration in 2017.
2. On strengthening cell therapy research and development support, rationalizing product outlets
Our committee has supported a number of pharmaceutical companies and scientific research institutions in the major scientific and technological special project plan of "Major New Drug Creation" and "Prevention and Treatment of Major Infectious Diseases such as AIDS and Viral Hepatitis" to carry out developments including lung cancer, liver cancer and multiple myeloma. Research on multiple CAR-T technical varieties. A total of approximately 41.4 million yuan was invested in the central government to support the cultivation and development of related innovation teams. There are already a number of CAR-T research projects in the new drug special 2018 project plan that have been incorporated into the project through open selection. At present, several domestic companies with relatively fast R&D progress and strong strength will be funded. In order to open the way for cell therapy related research and products, at the end of 2017, our committee and the former State Food and Drug Administration issued the "Technical Guidelines for the Research and Evaluation of Cell Products (Trial)" to restart cell therapy product research and registration applications. The cell treatment products to be commercialized and industrialized as pharmaceuticals shall be specified in detail, and the products that meet the relevant regulations can be put on the market. Recently, more than 10 cell therapy products will be approved for clinical trials.
3. Improving the technical review capability of innovative biological drugs such as immune cell therapy
In the project planning of the National Science and Technology Major Special Project of "Major New Drug Creation" in 2018, our committee entrusted the China Food and Drug Inspection Institute to undertake the targeted project "Research on the Evaluation and Standardization of Innovative Biotechnology Drugs" and establish relevant innovative biotechnology drugs as soon as possible. A scientific evaluation system to break the technical bottleneck of the review, support the evaluation and standardization of innovative biotech drugs such as cells and gene therapy drugs, and pave the way for the management of preparations with drug properties such as cellular immunotherapy according to drugs.
Your suggestions are of great significance for promoting the development of cell therapy in my country. We will seriously study and absorb and actively promote the above-mentioned related work.
Thank you for your care and support for health work.
National Health Commission