Research Ⅶ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Research on the Management Strategies for the Sponsors and Production Sites and Their Changes during the Clinical Research Phase of New Drugs in China
Objective:To propose management strategies for sponsors,production sites,and their changes during the clinical research phase of new drugs in China,to provide reference for adapting to the new situation of drug research and development and improving China's drug regulatory policies.Methods:This study analyzed the current issues in the management of sponsors and production sites in the clinical research phase in China,drew on the management experience of foreign regulatory agencies,conducted comprehensive assessment and judgment based on risk principles,and proposed relevant management countermeasures and suggestions suitable for China's national conditions.Results and Conclusion:With the core of ensuring the safety of subjects and the goal of encouraging innovation and improving the accessibility and availability of public medication,this study proposes specific management suggestions on strengthening the responsibility of sponsors as the main body,strengthening the quality management of clinical trial drug preparation,the pilot situation of moderately relaxing the cross-border and cross-border changes of applicants/sponsors and clinical trial drug production sites.
new drugclinical research phasesponsorproduction siteregistration managementchange management
NETL
NSTL
万方数据
