Page 17 - 2019年2月第30卷第4期

欧盟药品加速审评政策及实证分析

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李 轩 ，杨 庆，周 斌（中国医药工业研究总院/中国医药工业信息中心，上海 200040）
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中图分类号 R951 文献标志码 A 文章编号 1001-0408（2019）04-0443-05
DOI 10.6039/j.issn.1001-0408.2019.04.03

摘 要 目的：为我国新药审评审批制度的深入改革提供参考。方法：系统分析欧盟药品加速审评政策的法律基础，并与其他同
类政策进行比较；对加速审评流程的关键环节，尤其是加速审评申请的递交前准备、许可前检查、申请的递交和评估等详细流程进
行介绍。以Maviret为实例进行个案剖析，实证分析欧盟加速审评政策的应用效果。结果：加速审评是欧盟促进患者尽早获得新
药的几项法律条款之一，与条件上市许可、同情用药、优先药物计划、孤儿药认定、医院豁免等政策一样作为在欧盟尽早获得新药
的主要途径之一。当药物具备充分的治疗数据、具有重大公共健康利益和治疗创新性时，即有望获得加速审评。在欧盟法规
（726/2004/EC）的基础上，欧洲药品管理局（EMA）不断完善加速审评政策体系，相继发布了相关指导原则（指南）与加速审评程序
的执行时间表，为该政策的切实落地提供了详细、具体的指导。一旦药物进入加速审评程序，则其审评时间将由标准审评程序的
210日缩短至150日。治疗丙型肝炎病毒感染的新药Maviret从2017年1月20日开始加速审评，直到2017年6月22日获得EMA
人用药品委员会（CHMP）发布批准其上市许可的肯定意见，整个流程不到半年。结论：欧盟药品加速审评政策既有完善的立法支
持，又有详细具体的实施细则和执行时间表，能够加快一些公众急需的、具有特殊医疗优势的药品的上市速度。
关键词 欧盟；欧洲药品管理局；药品；加速审评

Empirical Analysis on the Policies of Drug Accelerated Assessment in the European Union
LI Xuan，YANG Qing，ZHOU Bin（China National Pharmaceutical Information Center/China State Institute of
Pharmaceutical Industry，Shanghai 200040，China）

ABSTRACT OBJECTIVE：To provide reference for in-depth reform of new drug assessment and approval system in China.
METHODS：The legal basis of drug accelerated assessment policies in European Union（EU）were analyzed systematically，and
then compared with other similar policies. The key steps of accelerated assessment procedure were introduced，in particular，
pre-submission preparation，pre-licensing inspection，submission and evaluation of accelerated assessment application. Taking
Maviret as an example，the effects of EU’s accelerated assessment policies were analyzed empirically. RESULTS：Accelerated
assessment is one of the EU’s several legal provisions to foster patients’early access to new drugs，as well as accelerated
assessment and conditional market licensing，sympathetic drug use，priority drug program，orphan drug identification and hospital
exemption，which were the main ways to obtain new drugs as soon as possible in the EU. The accelerated assessment was expected
when the drugs had sufficient treatment data，significant public health benefits and innovation. Based on EU’s regulations（No. 726/
2004/EC），European Medicines Agency（EMA）had continuously improved the policy system of accelerated assessment，issued
relevant guiding principle （guidelines） and timetables for the implementation of accelerated assessment procedures，providing
detailed and specific guidance for the practical landing of the policy. Once the drug entered the accelerated assessment procedure，
the assessment time would be shortened from 210 days of the standard procedure to 150 days. The assessment of Maviret，a new
drug for the treatment of hepatitis C virus infection，was accelerated from Jan. 20，2017 until Jun. 22，2017. When it was approved
by the EMA Committee for Human Medicinal Products（CHMP），the whole process was less than half a year. CONCLUSIONS：
EU drug acceleration assessment has not only perfect legislative support，but also detailed and specific implementation rules and
timetable. It can speed up the marketing of drugs which are required urgently by the public and have speeific medical advantages.
KEYWORDS European Union；European Medicines Agency；Drug；Accelerated assessment

使患者以合理的成本及时获得效果更好的新药是 共识。而患者能否及时获得新药主要受制于三个利益
当今全球卫生保健制度的重要目标，这也是包括患者、 相关者群体：（1）负责研发新药的制药/生物技术企业；
卫生服务提供者、学术研究者、监管者、卫生技术评估 （2）负责新药安全性、有效性和质量数据审查及后续的
和/或支付机构以及制药企业在内的利益相关方之间的
监管决策并确保新药及时上市的监管者；（3）负责评估
＊讲师，博士研究生。研究方向：国外药事政策与法规。电话： 和/或支付药品费用的机构（在不同的国家和地区可能不
021-62892865。E-mail：chinalixuan@qq.com
是同一组织），即患者获得新药的最后的“守门人”。
[1]
# 通信作者：研究员，博士生导师，博士。研究方向：医药政策法
规。电话：021-62892865。E-mail：zhoubin@sinopharm.com 作为欧盟官方药品管理机构，欧洲药品管理局（Eu-

中国药房 2019年第30卷第4期 China Pharmacy 2019 Vol. 30 No. 4 ·443 ·