Research Ⅳ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Research and Analysis on the Current Situation of Sponsor and Production Site Changes in the Clinical Research Phase in China
Objective:To provide reference for improving the regulatory system of drug clinical trials and change management during clinical trials by reviewing the corresponding regulatory requirements in China and investigating the current situation of the industry.Methods:Literature research on the regulatory requirements for clinical trials and their changes in China,as well as survey on the status quo of the industry,were conducted to provide reference suggestions for the subsequent improvement of the regulatory system of drug clinical trials and change management during clinical trials in China.Results and Conclusion:The reform of drug evaluation and approval in China has been continuously improved in recent years,and there are demands for"cross-border"and changes in sponsors and production sites along with the development of the industry.Considering the practical needs of innovative development and current regulations,under controllable risk conditions,China has a certain foundation to support the"cross-border"and"cross-border changes"of sponsors and clinical trial drug production sites.
clinical trialchange managementsponsor changeproduction site changedrug registration
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