Research Ⅲ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:The Enlightenment of the Requirements for Drug Clinical Trials and Change Management during Clinical Trials in the United States on Improving China's Reg
Objective:To study the regulatory requirements and implementation of the change management during the clinical research of drugs in the United States,and compare it with the current construction and implementation status of relevant regulatory regulations in China,in order to provide reference for improving the regulatory system of the change management of sponsors and production sites during the clinical research of drugs in China.Methods:A systematic review and study of regulatory regulations on the change of sponsors and production sites during the clinical research in the United States was conducted.Suggestions were provided based on the current situation of change management during the clinical research in China.Results and Conclusion:The regulatory system for drug clinical trials in the United States adopts a combination of approval and inspection,and allows sponsors and production sites to exist in different countries(cross-border)under the premise of controllable risks by strengthening the sponsor responsibility system.In recent years,China's drug review and approval reform has been continuously deepening,and a regulatory system for changes during clinical trials has been initially established.In the future,the relevant requirements for changes during clinical trials in China can be refined in stages to support industrial development.
clinical trialchange managementsponsor changeproduction site changedrug registration
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