Research Ⅴ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Research on Risk Assessment and Risk Control of Different Combinations of Sponsors and Production Sites
Objective:To conduct risk assessment and risk control research on different combinations of domestic and overseas sponsors and clinical trial drug production sites during the clinical trial phase of new drugs,and in order to provide reference for further improving the cross-border management of sponsors and production sites during the clinical trial phase in China.Methods:Failure Mode and Effect Analysis and Risk Priority Number were used to identify,analyze,and assess the risks of different combinations of domestic and overseas sponsors and production sites.Results and Conclusion:During the clinical trial phase of new drugs,"the sponsor is in China while the production site is overseas(for global supply)"and"the sponsor is overseas while the production site is in China"are two low-risk cross-border situations,and potential risks can be controlled through appropriate measures.It is recommended to prioritize the registration path for these two cross-border situations.
drug clinical trialsponsorproduction siterisk assessmentrisk control