Considerations of strengthening the human genetic resources management in drug clinical trials
SU Chang1 XU Lingyan2 SU Yuwen1,3▲
1. National Institute for Drug Clinical Trial, Sir Run Run Hospital, Nanjing Medical University, Jiangsu Province, Nanjing 211100,China;
2.Medical Ethics Committee,Sir Run Run Hospital,Nanjing Medical University,Jiangsu Province,Nanjing 211100, China;
3. College of Pharmacy, Nanjing Medical University, Jiangsu Province, Nanjing 211100,China
Since the reform of Drug Regulatory System in 2015 as well as the Drug Review and Approval System, the level of domestic drug clinical trials has promoted rapidly and China's pharmaceutical innovation industry has been continuously integrated with the chain of global innovation industry. As the import of global innovative drugs being promoted, domestic new drugs are also gradually going to the world. The newly revised Drug Administration Law (2019)and Drug Registration Administration Measures (2020) have further stimulated the innovative drugs research and development with drug clinical trials in China, which becomes the major development trend. However, an increasing number of drug clinical trials are involved in the collection, utilization, export and etc. of human genetic resources. Therefore, strengthening the management of human genetic resources is vital to national security. In this paper, analyzed the current situation of human genetic resources management during the whole process including the beginning, ongoing and ending of drug clinical trials in Sir Run Run Hospital, Nanjing Medical University. The corresponding suggestions covering the division of responsibility, organization and training, quality management system and the information management process of human genetic resources management, in order to further improve the quality of drug clinical trials.
苏 畅;徐玲燕; 苏钰文. 加强药物临床试验中人类遗传资源管理的思考[J]. 中国当代医药, 2022, 29(18): 141-144.
SU Chang1 XU Lingyan2 SU Yuwen1,3▲. Considerations of strengthening the human genetic resources management in drug clinical trials. 中国当代医药, 2022, 29(18): 141-144.