Research,Design,and Application of the Provincial Drug Evaluation Inspection Collaborative Supervision Mechanism
Objective:This study aims to explore and establish an effective provincial-level drug evaluation and inspection collaborative regulatory mechanism to enhance the efficiency and quality of drug regulatory decisions.Methods:Literature review and questionnaire surveys were used to analyze the current status and issues of collaborative regulation at the provincial level.Results:The findings indicate that review and inspection collaboration represent a new direction for implementing life-cycle management of drugs.The explorations of the FDA in this area provide important insights for China.Currently,provincial drug regulatory authorities in China have made some progress in collaborative regulation.However,issues such as insufficient information sharing and unsmooth regulatory processes still exist.Conclusion:This study proposes a framework for building a provincial drug evaluation and inspection collaborative regulatory mechanism,emphasizing risk orientation,full process control,and co-governance sharing.The study suggests establishing a regulatory data interaction system centered on the national intelligent regulatory platform and implementing specific collaborative regulation measures at various levels.
provincial drug regulationreview and inspection collaborationrisk closed-loopmechanism researchexample application
万方数据
维普
