Page 12 - 2021年17期

Study on the Policy Trends of Encouraged Generic Drug Catalogue in China
WANG Shengming，TIAN Kan，WANG Zihong（College of Health Economics and Management， Nanjing
University of TCM，Nanjing 210023，China）

ABSTRACT OBJECTIVE：To know about the current situation and trend of encouraged generic drug catalogue policy in China，
and to put forward countermeasures and suggestions for the better implementation of the policy. METHODS：The evolution of
encouraged generic drug catalogue policy in China，the characteristics of 2 batches of included types in encouraged generic drug
catalogue，the implementation effect of the first batch of encouraged generic drug catalogue，the development trend and existing
problems of encouraged generic drug catalogue policy were analyzed to put forward corresponding suggestions. RESULTS &
CONCLUSIONS：The evolution of encouraged generic drug catalogue policy in China can be roughly divided into embryonic
stage，policy design stage and policy implementation and adjustment stage. The first batch of included types in encouraged generic
drug catalogue are mainly drugs whose patents are about to expire and the competition is insufficient，drugs with clinical necessity，
definite curative effect and short supply，and varieties for special clinical purposes such as the prevention and treatment of major
infectious diseases and rare diseases，and children’s use. The second batch of included types in encouraged generic drug catalogue
are mainly those with expired patents（about to expired）and insufficient competition，and also those with special clinical uses.
Among the types of the first batch of encouraged generic drug catalogue，the number of abbreviated new drug application（ADNA）
increased by 18，involving a total of 8 varieties；only 3 ADNA were included in the priority review，accounting for 16.67％. In
2019 and 2020，218 and 119 varieties were newly included in the medical insurance catalogue，and 3 varieties were newly included
in the encouraged generic drugs catalogue （accounting for 1.4％ and 2.5％ respectively）. At present，encouraged generic drug
catalogue policy in China has the trend and characteristics of patent oriented regression，lack of priority review and approval
system，and enhanced linkage with the medical insurance catalogue. It is suggested to adhere to the original intention of the
Opinions of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of
Drugs and Medical Devices in 2017，continue to adhere to the patent orientation of encouraged generic drug catalogue，and
improve the priority review system of generic drugs in the catalogue，explore the“first imitation market monopoly period”system
in line with the characteristics of encouraged generic drug catalogue policy in China with reference to the U.S. FDA competitive
imitation therapy guidelines，and further strengthen the cooperation between government departments in the implementation of the
encouraged generic drug catalogue policy.
KEYWORDS Encouraged generic drug catalogue；Policy；Patent；Generic drug

为进一步提高我国药品供应保障能力，满足我国日 见》（以下简称“2017 年《意见》”）中“定期发布专利权到
益增长的临床用药及公共卫生安全需求，我国鼓励仿制 期、终止、无效且尚无仿制申请的药品清单”的要求 ，国
[2]
药品目录政策应运而生。截至2021年3月，国家卫生健 务院办公厅《关于改革完善仿制药供应保障及使用政策
康委已累计发布了两批鼓励仿制药品目录，累计纳入品 的意见》（以下简称“2018年《意见》”）和国家卫生健康委
种 49 个。为促进鼓励仿制药品目录及其配套政策更好 等12个部门《关于印发加快落实仿制药供应保障及使用
地落地见效，本文拟对我国鼓励仿制药品目录政策的现 政策工作方案的通知》（以下简称“《通知》”）于2018年相
状和趋势进行分析，以期发现当前鼓励仿制药品目录政 继出台 [3－4] ，并作为关键性指导文件，基本完成了以临床
策执行中存在的不足，并提出对策和建议。 必需、疗效确切、供应短缺以及重大传染病防治和罕见
1 我国鼓励仿制药品目录政策的演变 病治疗所需、处置突发公共卫生事件所需、儿童使用、专
回顾我国鼓励仿制药品目录政策的演变，大致可分 利到期前一年尚没有提出注册申请的药品为纳入条
[3]
为3个阶段，如表1所示。一是雏形阶段：1992年发布的 件 ，以纳入鼓励仿制药品目录的仿制药按规定予以优
《中药品种保护条例》第十九条规定，“对临床用药紧缺 先审评审批和将目录内的重点化学药品、生物药品关键
的中药保护品种，根据国家中药生产经营主管部门提出 共性技术研究纳入国家相关科技计划为主要保障、激励
的仿制建议，经国务院卫生行政部门批准，由仿制企业 措施 [3－4] ，自第二批鼓励仿制药品目录起每年年底更新
所在地的省、自治区、直辖市卫生行政部门对生产同一 一次鼓励仿制药品目录政策的制度设计。三是以 2019
[1]
中药保护品种的企业发放批准文号”，该规定可视为我 年下半年第一批鼓励仿制药品目录发布为标志的政策
国鼓励仿制药品目录政策的雏形。二是政策设计阶段： 执行和调整阶段：在政策执行过程中，除发布了两批鼓
根据 2017 年中共中央办公厅、国务院办公厅印发的《关 励仿制药品目录外，鼓励仿制药品目录政策还与其他政
于深化审评审批制度改革鼓励药品医疗器械创新的意 策产生关联，其中以国家医保局《2020 年国家医保药品

·2054 · China Pharmacy 2021 Vol. 32 No. 17 中国药房 2021年第32卷第17期