On 24th May, an online training session on "Technical Guidelines for Clinical R&D of Cell and Gene Therapy Products" was successfully held under the guidance of Centre for Drug Evaluation, NMPA, hosted by the Yangtze River Delta Centre for Drug Evaluation and Inspection of NMPA and organised by the National Medical Products Administration Institute of Executive Development. More than 6,000 participants from drug regulatory agencies, pharmaceutical companies and R&D institutions attended the training.

The training was conducted by Gao Chenyan, Director of the Clinical Department of Biological Products of the Drug Review Center, Lu Shuang, Deputy Director, and five senior reviewers, including Huang Yunhong, Gao Jianchao, Liu Xiao, Zhao Chenyang, and Liu Yantong, who gave detailed explanations around the "Technical Guidelines for Clinical Trials of Immunocellular Therapeutic Products (for Trial Implementation)" and the "Technical Guidelines for Clinical Risk Management Plans of the Declaration of Listed Clinical Risk Management Programs of Chimeric Antigen Receptor T Cells (CAR-T) Therapeutic Products" and so on. The experts also gave detailed explanations on the R&D process of enterprises. The experts also provided targeted answers to the difficulties and related issues encountered by enterprises in the R&D process.

In recent years, technologies such as cell therapy and gene editing have been developing vigorously, in which the development of related industries in the Yangtze River Delta region is relatively concentrated, with the number of R&D enterprises engaged in cell and gene therapy products and the number of those carrying out clinical trials accounting for more than 50% of the country. In the next step, the Center for Drug Control and Prevention will promote regulatory scientific research, accelerate the formulation of cell gene therapy guidelines, and actively serve the high-quality development of the cell and gene therapy industry.

Translated Excerpts from web article: https://www.cde.org.cn/main/newspic/view/25775636cc283af3989f3cef36a93cad