| Objective: To study the relevant laws and regulations and literature on experimental drugs at homeand abroad, and analyze the relevant problems and solutions. Methods: Literatures related to drugs used inclinical trials were retrieved from databases such as CNKI, Wanfang, VIP, etc. According to the trial process, theresponsibilities and issues of trial parties such as the sponsors/contract research organization (CRO), researchers,drug clinical trial institutions, and ethical review committees were analyzed. Results: The construction of a qualitysystem for drug clinical trials was an important part of quality assurance in clinical trials. There articles elaboratedon the production, transportation, use, and safety of experimental drugs, and obtained more comprehensiveresearch results. Conclusion: This article analyzes the policies and regulations in the management process ofclinical experimental drugs, and propose the relevant problems and solutions, which is benefi cial for improvingthe quality of experimental drug management, protecting the rights and safety of subjects, and ensuring the smoothprogress of trials, and has an important reference and learning signifi cance. |