To the First Session of the 13th National People’s Congress
Reply to Suggestion No. 6238
Represents:
Your suggestions on rapidly promoting the clinical translation and application of cellular immunotherapy are accepted. After consulting with the State Food and Drug Administration, the reply is as follows:
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 measures for clinical research and translational application of somatic cell therapy, and plans to solicit opinions from the society in the near future. During the formulation process, the experience in registration system management of stem cell clinical research was used to manage somatic cell therapies independently developed and prepared by medical institutions and carried out within the medical institutions. At the same time, we fully absorb the opinions of relevant experts and apply for clinical trials and marketing licenses for somatic cell preparations produced as pharmaceuticals in accordance with the “Technical Guiding Principles for Research and Evaluation of Cell Products (Trial)” issued by the former State Food and Drug Administration in 2017.
Supported a number of pharmaceutical companies and scientific research institutions to carry out research on multiple CAR-T technology varieties, including lung cancer, liver cancer, and multiple myeloma. A total of approximately 41.4 million yuan of central government funds have been invested to support the cultivation and development of relevant innovation teams. In the 2018 project plan of the New Drug Special Project, several CAR-T research projects have been included in the project through public selection. Currently, several domestic companies with rapid R&D progress and strong strength will receive funding. In order to open up avenues 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 Guiding Principles for Research and Evaluation of Cell Products (Trial)”, restarting the research and registration applications for cell therapy products, and stipulating in detail the conditions required for cell therapy products that are intended to be commercialized and industrially produced as drugs. Products that meet relevant regulations can be put on the market. Recently, more than 10 cell therapy products will be approved for clinical trials.
In the 2018 annual project establishment plan of the “Major New Drug Creation” National Science and Technology Major Project, our committee entrusted the China Institute of Food and Drug Control to undertake the targeted project “Research on Key Technologies for Evaluation and Standardization of Innovative Biotechnology Drugs”,Establish a scientific evaluation system for relevant innovative biotech drugs as soon as possible to break the technical bottleneck of evaluation, support the evaluation and standardization research of innovative biotech drugs such as cell 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 to promoting the development of cell therapy in our country. We will seriously study and absorb them and actively promote the above-mentioned related work.
Thank you for your concern and support for health work.
National Health Commission