Page 15 - 2020年2月第31卷第3期

英国药品和医疗器械监管局法律监管情况概述及启示 Δ

＊
鄢 广（贵阳学院法学院，贵阳 550005）

中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）03-0265-06
DOI 10.6039/j.issn.1001-0408.2020.03.03

摘 要 目的：为提高我国药品监管效能提供参考。方法：对英国药品和医疗器械监管局（MHRA）的法律性质与职能范围，监管
目标、方式及其程序的法律要素，英国药品监管效能提高计划的实施及成效等进行分析，并提出对我国的启示。结果与结论：
MHRA属于英国卫生与社会保障部的执行机构，其法律责任由英国卫生与社会保障部部长承担，其职能范围包括监管药品、医疗
器械、输血制品；其监管目标包括对药品和医疗器械进行行政监管、向患者提供医药信息、鼓励医药企业研发新型有效产品；其监
管方式包括行政立法与法规审查、药物预警、市场准入和行政协议；开放、透明、参与、合作的法律要素可以提供监管行为的正当
性。MHRA于2005年了启动药品监管效能提高计划，旨在削减不必要的药品监管负担，实现适度、基于风险、有针对性和具有成
本效益的药品监管，这一计划使得英国的药品监管机构效能提升、医药企业负担减轻、患者健康权益得到保障。我国可借鉴英国
MHRA监管实践经验，确立从被动管制到主动监管、从事后监督到风险监管、从行政主导到合作共管的现代监管理念，强化监管
责任，充分利用当代信息技术和大数据技术，以提高我国药品监管效能，切实维护公众健康权益。
关键词 英国；药品和医疗器械监管局；法律监管；监管效能；启示

Legal Regulatory Overview on UK Medicine and Healthcare Products Regulatory Agency and Its
Enlightenment
YAN Guang（School of Law，Guiyang University，Guiyang 550005，China）

ABSTRACT OBJECTIVE：To provide reference for improving the efficiency of medicine regulation in China. METHODS：The
legal nature and functional scope，regulatory objectives，methods and legal elements of UK Medicine and Healthcare Products
Regulatory Agency（MHRA），and the implementation and effectiveness of the drug regulatory effectiveness improvement plan in
the UK were analyzed to put forward the enlightenment for China. RESULTS & CONCLUSIONS：MHRA belongs to the
enforcement agency of UK Department of Health and Social Care，and its legal responsibility is borne by the Minister of Health. Its
functions include the supervision of medicine，medical devices，blood transfusion products. Its objectives include the administrative
supervision of medicine and medical devices，the provision of medical information to patients，and the encouragement of
pharmaceutical enterprises to develop new and effective products. Its supervision methods include the supervision of administrative
legislation and regulations，drug early warning，admission to market and administrative agreement；the legal elements as openness，
transparence，cooperation and participation guarantee the legitimacy of regulatory actions. MHRA launched the medicine regulatory
performance improvement plan in 2005， aiming to reduce unnecessary medicine regulatory burden and achieve moderate，
risk-based，targeted and cost-effective drug regulation. This plan makes medicine regulatory agencies improve efficiency，reduce
burden of pharmaceutical enterprises and protect patients’health rights and interests. Our country can learn from the experience of
MHRA regulatory practice in the UK，establish modern regulatory concepts such as from passive regulation to active regulation，
from post supervision to risk supervision，from administrative guidance to cooperative management，so as to strengthen regulatory
responsibility，make full use of modern information technology and big data technology，so as to improve the efficiency of drug
regulation in China and effectively safeguard the public health rights and interests.
KEYWORDS UK； Medicine and Healthcare Products Regulation Agency； Legal regulation； Regulatory effectiveness；
Enlightenment

在大部制改革 背景下，2017年英国卫生部（Depart- 品监管、医疗卫生事务管理的基础上，增加了社会保障
[1]
ment of Health）扩展行政职能并更名为英国卫生与社会 职能。英国药品和保健品管理局（Medicines and Health-
保障部（Department of Health and Social Care），在原有药 care Products Regulatory Agency，MHRA）是卫生与社会

Δ 基金项目：国家社会科学基金资助项目（No.16XFX015）；贵阳 保障部下属两大主要执行机构之一，是全球公认的药品
市科学技术局-贵阳学院科技专项资金项目[No.GYU-KYZ（2019－ 与医疗器械监管领域的权威机构 ，在保障药品安全有
[2]
2020）FX-11]
效性与促进公众健康方面具有国际性影响。
＊法学博士。研究方向：行政法与行政诉讼法、卫生行政法学。
E-mail：2054379300@qq.com 近年来我国药品监管效能有了一定提升，但药品安

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