从药品质量标准的视角探讨药品的监督与管理

Discussion on Drug Supervision and Management from the Perspective of Drug Quality Standards

目的:从药品质量标准的视角探讨如何进一步加强药品的监督与管理,促进医药产业发展、保障公众用药安全。方法:通过对监督抽检发现的药品质量标准存在的问题进行分析研究,提出相应的解决措施和意见建议。结果与结论:部分药品质量标准在标准制定、审批发布、标准管理、标准执行以及质量标准的可及性等方面存在不足,影响了质量标准的执行和药品生产及安全监管,应从建立药品审评审批与药品质量标准管理的联动机制、完善监督抽检机制、加强对药品质量标准执行的监管等方面加以解决。

Objective:To discuss how to further strengthen the supervision and management of drugs from the perspective of drug quality standards,to promote the development of the drug industry and to ensure the safety of public medication.Methods:Through the analysis and research on the problems existing in the quality standards of drugs which are discovered by supervision and sampling,the corresponding solutions and suggestions were put forward.Results and Conclusion:Some drug quality standards were imperfect in standard formulation, approval and release,standard management,standard implementation,and accessibility to quality standards, which adversely affects the implementation of quality standards and drug production and safety supervision.It was suggested that the mechanism of drug review and approval linked with drug quality standard management should be established,the supervision and sampling mechanism should be improved,and the supervision of implementation of drug quality standards should be strengthened.