Drug clinical trial agency will manage classified

The National Drug Clinical Trial Quality Management Conference was held in Beijing. Wu Wei, the deputy director of the State Food and Drug Administration, said at the meeting that there are currently 333 drug clinical trial institutions that have passed China's accreditation, and the State Food and Drug Administration will use Phase I clinical trials as the starting point for the management of these institutions. . In the future, only confirmed clinical trial laboratories can carry out the first human trials of innovative drugs.

Wu Hao said that phase I drug clinical trials, especially the first human drug clinical trials, are often performed on healthy people including the safety evaluation including the maximum tolerability test. The State Food and Drug Administration will formulate corresponding inspection standards based on the established guiding principles, and conduct inspections on the Phase I clinical trial research laboratory to confirm that the research laboratory with the subject leaders, test facilities complying with international standards, and a sound quality management system will undertake the first human trials. the study.

The meeting revealed that preliminary results have been achieved in pilot trials of the drug clinical trial regulatory information system. The system will be further expanded and piloted, and will eventually be used throughout the country. According to reports, the system is a dynamic monitoring platform for drug clinical trials, including institutional dynamic management information and pilot project management information.