[The State Food and Drug Administration deploys and optimizes the management of chemical raw materials and the review and approval of cell and gene therapy drugs] On November 13, Huang Guo, Secretary of the Party Leadership Group and Director of the State Food and Drug Administration, chaired a meeting to study and deploy related work such as optimizing the management of chemical raw materials and the review and approval of cell and gene therapy drugs. The "Regulations on the Management of Changes in Registration Subjects of Chemical Raw Materials" and the "Announcement on Optimizing the Review and Approval of Cell and Gene Therapy Drugs" were reviewed and approved. The meeting pointed out that chemical raw materials are a key link in improving and strengthening the pharmaceutical industry chain and supply chain, and the management of chemical raw materials must be continuously optimized. The newly revised "Regulations for the Implementation of the Drug Administration Law" stipulates that chemical raw material drug approval certificates can be transferred. In order to implement this system, the "Regulations on the Management of Changes in Registration Subjects of Chemical Raw Materials" must be formulated and implemented to clarify the application requirements, work procedures, and responsibilities and obligations of all relevant parties for the transfer of chemical raw material drug approval certificates. Reforms will be promoted on the basis of ensuring the quality and safety of chemical raw materials, continuously stimulating industry vitality, and promoting the high-quality development of the chemical raw material industry. The meeting pointed out that cell and gene therapy are key innovation-driven areas in the biomedical industry and one of the new productive forces that promote the high-quality development of the biomedical industry. It is necessary to formulate and implement the "Announcement on Optimizing the Review and Approval of Cell and Gene Therapy Drugs", clarify specific work measures to optimize the review and approval of cell and gene therapy drugs in terms of improving the quality and efficiency of clinical research and development, service support for key innovative varieties, strengthening early intervention in registration inspection, strengthening the role of expert support, and continuously improving technical standards. It covers key aspects of the entire life cycle of drugs such as clinical research and development, registration and application, review and approval, and post-marketing changes, and provides full-process system support.