Objective: To provide references for improving the supervision system of pharmacovigilance and risk control during clinical trials of new drugs in China. Methods: Based on the research project of "Research on Pharmacovigilance and Risk Control during Clinical Trials of New Drugs" organized by our research group, on the basis of papers including in-depth research on the pharmacovigilance regulatory system of Europe and the United States, the comparative analysis of domestic and foreign pharmacovigilance regulations and guiding principles, and the comprehensive analysis combined with the questionnaire survey results, suggestions on improving the regulatory system of pharmacovigilance and risk control during new drug clinical trials in China were put forward. Results and Conclusion: From the perspective of the supervision system and key elements, some suggestions were made to improve the supervision system of pharmacovigilance and risk control during the clinical trial of new drugs in China, including improving the personnel training of regulatory system, publicizing and implementing relevant policies and regulations, introducing professionals, sharing regulatory information, and strengthen the management of key pharmacovigilance elements such as clinical trial protocol, investigator's brochure, informed consent, suspected unexpected serious adverse reaction (SUSAR) and development safety update report (DSUR), review and feedback of DSUR, adverse reaction event report, risk control plan (RCP), etc.