T/SHPPA 021-2023 CAR-T cell therapy product and its material entry and exit management guideline

Scope

Main technical content: With the rapid development of advanced cell therapy technologies, cell therapy products represented by CAR-T cells have been successively put on the market in China and overseas. China has already met certain clinical needs for the production of CAR-T cell therapy products and their sale or clinical trials abroad, and the demand for the import and export of CAR-T cell therapy products and their production materials has grown rapidly. The formulation of this document aims 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 the collection, procurement, transportation, and receipt of raw materials, as well as the production, inspection, and use of CAR-T cell therapy products. It also regulates the import and export of CAR-T cell therapy products and their materials, promoting the rapid and orderly development of the cell therapy industry.

Development Information

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