中国药品质量风险提示函机制态势分析

Analysis on the Situation of Drug Quality Risk Reminder Mechanism in China

关键词:  药品抽检  提示函  劝服优先  SWOT  失效模式  补救机制

Key words:  drug sampling and testing  reminder letter  persuasion first  SWOT  failure mode  remedial mechanism

摘要:

目的 为进一步完善中国药品抽检的质量风险提示函机制提供参考。方法 介绍中国药品质量风险提示函的情况和药品质量风险的新形势，借助SWOT方法分析提示函在新形势下的优势、劣势、机会和威胁，对提示函进行整体评价并提出完善建议。结果与结论 近年来，中国药品质量仍处于较高水平，安全形势总体平稳可控，但一般性风险仍然存在并具有不可消除性。提示函作为中国药监部门基于劝服优先的原则对一般性风险进行干预的行政措施，面临着诸多内部和外部的有利与不利因素，建议药品生产企业进一步加强提示函的利用，药检机构进一步提供技术支持，以及药监部门建立提示函的失效补救机制，对提示函进行不断加强和完善。

Abstract:

OBJECTIVE To provide a reference for further improving the quality risk reminder mechanism of the drug sampling and testing in China. METHODS Introduced the drug quality risk reminder letter and the new drug quality risk situation in China, used the SWOT method to analyze the strengths, weakness, opportunities and threats of the reminder letter under the new situation, and conducted an overall evaluation of the reminder letter and put forward the improvement suggestions. RESULTS & CONCLUSION Recently, the drug quality is at a relatively high level, and the safety situation is generally stable and controllable in China, but non-serious risks still exist and cannot be eliminated. As an administrative measure for drug regulatory agencies to intervene non-serious risks based on the persuasion first principle, the reminder letter mechanism faces both internal and external advantages and disadvantages. It is suggested that the manufacturers further strengthen the use of reminder letters, and drug test institutes further provide technical support, and the drug regulatory department establish a failure remedial mechanism to continuously strengthen and improve the reminder letter mechanism.