In recent years, tumor immunotherapy technology has made rapid progress, and gene-modified cell products represented by chimeric antigen receptor modified T cells (CAR-T) have entered the clinic one after another. The breakthrough progress of cell therapy products and the approval of foreign CAR-T cell therapy products have brought new hope for the treatment of patients with advanced tumors. CAR-T cell products are "live" cell drugs and cannot tolerate virus inactivation/terminal sterilization. The products themselves are highly "individualized" and "heterogeneous", and the production process and quality control are highly "complex" and "specific". Previously, some research data were obtained from non-registered clinical trials conducted in accordance with "medical technology", but according to drug development and application, the integrity, standardization, traceability, quality system and risk control requirements of the accepted application materials have many defects, which affect the review progress.
In order to encourage innovation in CAR-T products, meet the urgent need for clinical drug use, and make preparations for the pharmaceutical research and application materials in the application stage of clinical trials, applicants are requested to pay special attention to the following aspects of pharmaceutical research and application materials on the basis of conducting relevant research in accordance with the requirements of technical guidelines. Consideration points.
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