Page 21 - 《中国药房》2021年21期

我国药品抽检质量风险提示函制度的探讨 Δ

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刘 文 ，王 翀 ，朱 炯 ，胡增峣（1.中国食品药品检定研究院，北京 102629；2.国家药品监督管理局，
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北京 100037）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2021）21-2575-06
DOI 10.6039/j.issn.1001-0408.2021.21.03

摘 要 目的：为进一步完善我国药品抽检质量风险提示函（以下简称“提示函”）制度、加强药品质量管理水平提供参考。方法：
概述我国药品抽检的质量风险管理情况，对其中提示函的法律性质、主要内容和工作程序进行分析，以最新的2020年的提示函数
据为例分析提示函在排查潜在药品质量风险中的作用，并针对目前存在的问题提出完善建议。结果与结论：在基于法定标准检验
的同时，我国药品监督管理部门对可能因生产企业的药品质量控制盲区或偏差而存在质量安全风险的药品开展了探索性研究，并
按照发现问题的严重程度分为严重风险和一般性风险，实施分级管理。提示函就是基于劝服优先的原则对一般性药品质量风险
制定的行政措施，不具有制裁性。其主要内容涵盖风险排查整改所需全部信息（药品基本信息、提示的风险信息、联系人信息、发
现风险的方法、排查整改要求、属地省级药监部门的职责），涉及承检机构、中国食品药品检定研究院、国家药监局、相关生产企业
属地省级药监局与相关生产企业共五方责任主体，通过闭环管理的模式实现监管部门与生产企业之间的良性互动。2020年，国
家药监局共向286家生产企业发出312份提示函，提示准确率达87.91％，具有较好的科学性和针对性。生产企业针对提示函的内
容进行了包括开展工艺验证、修订内控标准、加强生产过程控制等一系列整改措施，但也存在提示内容的合理性遭到生产企业质
疑以及生产企业排查力度不足等问题。鉴于此，笔者建议生产企业要正确认识提示函的性质和价值，承检机构应进一步提高发现
问题的科学性和针对性，而药监部门则要重点关注排查发现的问题，以共同促进药品质量的提升。
关键词 药品抽检；风险管理；提示函；劝服优先

Discussion on the Quality Risk Reminder Mechanism of Drug Sampling and Testing in China
LIU Wen ，WANG Chong ，ZHU Jiong ，HU Zengyao（1. National Institutes for Food and Drug Control，Beijing
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102629，China；2. National Medical Products Administration，Beijing 100037，China）
ABSTRACT OBJECTIVE：To provide a reference for further improving the quality risk reminder mechanism of the drug
sampling and testing（called“the Reminder”as for short）in China，and strengthening the drug quality management. METHODS：
The quality risk management situation of the drug sampling and testing were summarized，and the legal nature，main content and
working procedures of the Reminder were analyzed. The latest data of the Reminder in 2020 were taken as an example to analyze
the role of the Reminder in the investigation of potential drug quality risks，and made the suggestions for existing problems.
RESULTS & CONCLUSIONS：Based on legal standards，China’s drug regulatory departments had carried out exploratory research
on drugs that may have quality and safety risks due to drug quality control blind spots or deviations of manufacturing enterprises，
and divided them into serious risks and general risks according to the severity of the problems found，and implemented hierarchical
management. The Reminder was an administrative measure for general drug quality risks based on the principle of persuasion first，
and did not have sanctions. Its main content covered all the information required for risk investigation and rectification（basic drug
information， suggested risk information， contact information， risk discovery methods， troubleshooting and rectification
requirements，and responsibilities of local provincial drug regulatory departments）. It involved five responsible parties，ie. the
inspection institution，China Institute for Food and Drug Control，National Medical Products Administration，the provincial food
and drug administration of the relevant manufacturing enterprises and the relevant manufacturing enterprises. Through the mode of
closed-loop management，the benign interaction between regulatory authorities and manufacturing enterprises could been realized.
In 2020，National Medical Products Administration issued 312 reminders to 286 manufacturers，with an accuracy of 87.91％，which
was scientific and targeted. The manufacturer had carried out a series of rectification measures for the contents of the Reminder，
including carrying out process verification，revising internal
Δ 基金项目：国家重点研发项目（No.2016YFE0205400）
control standards and strengthening production process control.
＊主管药师，硕士。研究方向：药品抽检政策与法规。电话：010-
However， there were also some problems， such as the
53851420。E-mail：liuwen@nifdc.org.cn
# 通信作者：副主任药师。研究方向：药品抽检政策与法规。电 rationality of the prompt contents being questioned by the
话：010-53851518。E-mail：zhujiong@nifdc.org.cn manufacturer and the insufficient investigation of the

中国药房 2021年第32卷第21期 China Pharmacy 2021 Vol. 32 No. 21 ·2575 ·