Breaking news: GMP guideline for cell therapy products issued

On October 31, 2022, the SFDA food and drug review and inspection center officially issued the guidance for the quality management of the manufacture of cell therapy products (Trial). The full text of the guideline covers thirteen chapters covering basic principles of GMP management of cell therapy products, personnel, plants, facilities and equipment, donor screening and donor materials, materials and products, production management, quality management, and product trace back system. The publication of the guidance implies that the whole industrial chain of cell therapy related sample collection, transportation, receipt, production, and treatment has a standardized document guidance and policy support, which further advances the development of cell therapy in China.

Cell therapy technologies have shown great promise in the treatment of cancer, hematological diseases, cardiovascular diseases, diabetes, and neurological diseases, especially in tumor immunotherapy. In order to actively advance the regulation of Frontier cell therapy products, guide the development of industry norms, establish specifications, and efficient inspection technology management requirements, the SFDA review and inspection center first issued GMP appendix - cell therapy products (manuscript for comments) on 28-nov-2019, and open access for comments. After discussion of the sought comments by the experts, further revision of the document, open again on 06-jan-2022. This issued guidance for the quality management of the manufacture of cell therapy products (Trial), which was revised from GMP annex - cell therapy products (manuscript for comments). The guidance refines and refines the technical requirements in the manufacturing quality management of the industrial stage of cell therapy products, and guides the marketing authorisation holder of medicines to regulate the production and quality management of cell therapy products. At the same time, it also provides important references for regulatory agencies to carry out various types of site inspections. It is important to develop and market cell therapy products in our company.

The cell medicine research unit is a subordinate unit of biomedical division, and the main research direction is cell storage, cell therapy drug and cell-derived product development. The field of cell therapy products is currently in a fast-moving phase, and the cell medicine research room will seize on the opportunity, strive forward, and promote cell technology, benefit the provenance!