Regulatory Status and Compliance Recommendations for mRNA Technology and Drugs in China

Currently, China still has no specific legislation for the messenger RNA (mRNA) field, so relevant R&D and application activities must comply with the general and specific provisions scattered in the existing legal framework. This study examines China's current regulatory landscape for mRNA technology and drug clinical application, focusing on the analysis of the regulatory frameworks and core legal requirements under the pathways of clinical application of medical technologies and drug registration for approval, and delves into the challenges faced in such areas as clinical translation, investigator-initiated trials (IITs), foreign investment access, technology export controls, ethics review, and China's human genetic resources management around such key aspects related to mRNA technologies and drugs as foreign investment access, scientific ethics review, clinical application of medical technologies, and full lifecycle management for drugs, aiming to propose corresponding compliance recommendations and to provide some guidance for enterprises of mRNA technologies and drugs in their compliance practices.