With the rapid development of advanced cell therapy technology, cell therapy products represented by CAR-T cells have been successively launched in China and overseas. There is a certain clinical demand for China's production of CAR-T cell therapy products and their overseas sales or clinical trials. The demand for the import and export of CAR-T cell therapy products and their production materials is growing rapidly. This document was developed to ensure the safety, stable quality and traceability of CAR-T cell therapy products, as well as biosafety during the R&D and production processes. This document proposes relevant requirements for CAR-T cell therapy products in the collection, procurement, transportation, receipt, production, inspection and use of raw materials, standardizes the entry and exit management of CAR-T cell therapy products and their materials, and promotes The rapid and orderly development of the cell therapy industry.
T/SHPPA 021-2023 history
2023T/SHPPA 021-2023 Import and export management guidance for CAR-T cell therapy products and their materials