Page 7 - 《中国药房》2021年23期

·药事管理·

国家药品质量通告制度分析与建议 Δ

刘 文 ，朱 炯 ，王 翀 ，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，北京
2
1 #
1＊
1
100037）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2021）23-2817-05
DOI 10.6039/j.issn.1001-0408.2021.23.01

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。
关键词 国家药品质量通告制度；药品质量；药品监管

Analysis and Suggestions on National Drug Quality Disclosure System
LIU Wen ，ZHU Jiong ，WANG Chong ，HU Zengyao（1. National Institutes for Food and Drug Control，Beijing
2
1
1
1
102629，China；2. National Medical Products Administration，Beijing 100037，China）
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.
KEYWORDS National drug quality disclosure system；Drug quality；Drug administration

近年来，药品质量安全信息越来越受到公众的关 国家药品质量通告是国家药品监督管理局（后文简称
注，尤其是涉及疫苗、药酒等产品的案件曾一度引起舆 “国家药监局”）根据国家药品抽检结果发布的药品质量
情发酵，这反映了公众对药品质量状况强烈的知情需 状况报告，是我国药品质量信息主动公开的法定渠道。
求，以及新闻媒体对药品质量状况较高的敏感度 [1－2] 。 随着以“四个最严”为宗旨的药品监管政策的发展变化，
Δ 基金项目：国家重点研发计划“战略性国际科技创新合作”重点 以及药品信息公开相关法规的修订，国家药品质量通告
专项（No.2016YFE0205400）
制度面临着新的药品监管形势和挑战。为此，笔者结合
＊主管药师，硕士。研究方向：药品抽检政策与法规。电话：010-
自身十余年来从事国家药品质量通告相关工作和参与
53851420。E-mail：liuwen@nifdc.org.cn
药品监管相关法规修订的经验，从基本情况、实施程序、
# 通信作者：副主任药师，硕士。研究方向：药品抽检政策与法
规。电话：010-53851418。E-mail：wangchong@nifdc.org.cn 实施现状及成效、存在的问题等方面对国家药品质量通

中国药房 2021年第32卷第23期 China Pharmacy 2021 Vol. 32 No. 23 ·2817 ·