Circular of the Center for Drug Evaluation Publication on the Technical Guidelines for Non-clinical Studies of Prophylactic mRNA Vaccines (No. 7 of 2025)

The CDE published a set of technical guidelines for conducting non-clinical research of preventive mRNA vaccines. The guidelines intend to advise sponsors on obtaining appropriate scientific and experimental data to support clinical trials and marketing applications for these products. Topics covered in the guidelines include methods for ensuring test substances are representative of clinical samples, aspects related to pharmacology, biodistribution studies, safety considerations (including whether different types of safety studies are required based on the test substance used), platform technology product development, and special considerations (e.g., monitoring for inflammatory reactions, evaluating toxicity of modified nucleosides).

Original link: https://www.cde.org.cn/main/news/viewInfoCommon/facfa51622da3ebcbcc053a88b46f51b