监管科学重点实验室建设与发展的思考

On Construction and Development of Key Laboratories for Regulatory Science

目的:推进监管科学重点实验室建设的科学性、规范性和权威性,提升我国药品监管的技术支撑和保障能力。方法:通过对规范性文件等的文献研究,厘清监管科学重点实验室的定位、特点、目标任务及其评审和管理,通过田野调查掌握监管科学重点实验室的建设现状,并对其成效与不足进行分析讨论。结果与结论:针对药品监管科学重点实验室数量较少、科技水平不高、支撑监管能力不足的现状,提出监管科学重点实验室的建设原则、标准和程序,明确发展思路和方向。

Objective:To promote the scientific,normative and authoritative construction of regulatory science key laboratories,so as to enhance the technical support and guarantee capability of drug regulation in China.Methods:Based on literature research on normative documents,the positioning,characteristics,objectives,tasks and their review and management of the regulatory science key laboratories were clarified,the current situation of the construction of regulatory science key laboratories was grasped through field surveys,and their effectiveness and shortcomings were analyzed and discussed.Results and Conclusion:In view of the current situation that the number of key laboratories for drug regulation science is small,the level of science and technology is not high,and the ability to support regulation is insufficient,the principles,standards and procedures for the construction of key laboratories for regulatory science are proposed,and routes to development are clarified.