The Comprehensive Affairs Department of NMPA Issued the Announcement on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cellular Therapy Products” (No. 216, 2017)

In recent years, with the continuous development of basic theories, technical means and clinical medical exploration and research such as stem cell therapy, immune cell therapy and gene editing, cell therapy products have provided new treatment ideas and methods for some serious and intractable diseases. This guideline is formulated to standardize and guide the research, development and evaluation of such products in accordance with drug management standards. Due to the rapid development of cell therapy product technology and the large differences in products, this principle is mainly based on current cognition and proposes general technical requirements for the safety, effectiveness and quality control of cell therapy products. With the development of technology, the improvement of cognition and the accumulation of experience, the specific technical requirements for products of different cell categories will be gradually improved, refined and revised. Since this guideline covers products of various cell types, the applicability of technical requirements should also adopt the principle of specific analysis of specific issues.

Specific news link: Notice of the General Administration on the issuance of technical guidelines for the research and evaluation of cell therapy products (No. 216 of 2017)