国家药品质量通告制度分析与建议-中国药房

国家药品质量通告制度分析与建议

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篇名：	国家药品质量通告制度分析与建议
TITLE：	Analysis and Suggestions on National Drug Quality Disclosure System
摘要：	目的：为进一步完善国家药品质量通告制度提供参考。方法：从基本情况、实施程序、实施现状及成效、存在的问题等方面对国家药品质量通告制度进行分析，并提出完善建议。结果与结论：国家药品质量通告制度经过了公报阶段、公告阶段、通告阶段，目前已成为发布及时、程序严谨且具有法律制裁性的药品监管措施。国家药品质量通告的发布过程包括告知抽检企业药品不合格的事实、对不合格药品进行风险控制、对被通告单位进行法律救济、准备国家药品质量通告内容、对外发布国家药品质量通告等5个步骤。近年来，国家药品监督管理局对国家药品质量通告的发布力度不断加大。国家药品质量通告的发布在倒逼药品生产企业提高药品质量、提升药监部门公信力方面发挥了重要作用，但同时省级药监局也存在不合格报告书送达不及时、对涉嫌假冒中药饮片的追溯时间过长、对申诉的初审把关不严等问题。建议国家药品监督管理局加大对省级药监局的培训、审核以及惩戒力度；同时，省级药监部门也需强化责任担当和业务能力建设，重视相关工作并加强日常监督。
ABSTRACT：	OBJECTIVE：To provide reference for further improving the national drug quality disclosure system. METHODS ： The national drug quality disclosure system was analyzed in respects of general information ，implementation procedure ， implementation situation and effects ，and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS：The national drug quality disclosure system had gone through the bulletin stage ，notice stage and announcement stage. At present ，it had become drug regulatory measure with timely release ，rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ，ie. informing the sampling enterprises of the fact that the drugs were unqualified，controlling the risk of unqualified drugs ，providing legal relief to the notified units ，preparing the contents of the national drug quality notice ，and releasing the national drug quality notice to the public. In recent years ，National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ，there are also some problems ，such as the non-conforming report is not delivered in time ，the tracing time for suspected counterfeit TCM pieces is too long ，and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ，review and punishment of provincial drug regulatory departments ；at the same time ，provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ，pay attention to relevant work and strengthen daily supervision.
期刊：	2021年第32卷第23期
作者：	刘文，朱炯，王翀，胡增峣
AUTHORS：	LIU Wen，ZHU Jiong，WANG Chong ，HU Zengyao
关键字：	国家药品质量通告制度；药品质量；药品监管
KEYWORDS：	National drug quality disclosure system ；Drug quality ；Drug administration
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