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我国鼓励仿制药品目录政策趋势研究
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| 篇名： | 我国鼓励仿制药品目录政策趋势研究 |
| TITLE： | Study on the Policy Trends of Encouraged Generic Drug Catalogue in China |
| 摘要： | 目的：了解我国鼓励仿制药品目录政策的现状和趋势，并为鼓励仿制药品目录政策更好地落实提出对策和建议。方法：对我国鼓励仿制药品目录政策的演变、两批鼓励仿制药品目录纳入品种的特点、第一批鼓励仿制药品目录的实施效果、鼓励仿制药品目录政策的发展趋势与存在问题等进行分析，并提出相应建议。结果与结论：我国鼓励仿制药品目录政策的演变大致分为雏形阶段、政策设计阶段以及政策执行和调整阶段。相较于第一批鼓励仿制药品目录纳入的品种主要以专利即将过期且竞争不充分的药品和临床必需、疗效确切、供应短缺的药品为主，兼顾重大传染病防治和罕见病治疗所需、儿童使用等特殊临床用途的品种；第二批鼓励仿制药品目录纳入的品种主要以专利（即将）过期且竞争不充分的品种为主，兼顾特殊临床用途的品种。第一批鼓励仿制药品目录品种的仿制药申请（ADNA）新增数为18个，共涉及8个品种；其中仅3个ADNA被纳入优先审评，占16.67％。2019、2020年医保目录新纳入品种分别有218个、119个，其中分别新纳入鼓励仿制药品目录内品种各3个（占比分别为1.4％和2.5％）。当前我国鼓励仿制药品目录存在专利导向回归、优先审评审批制度缺失、与医保目录联动性增强的趋势和特点。建议坚持2017年国务院《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》的初衷，继续坚持鼓励仿制药品目录的专利导向，完善目录内品种仿制药的优先审评制度，探索以美国FDA竞争性仿制疗法指南为参考的、符合我国鼓励仿制药品目录政策特点的“首仿市场独占期”制度，并进一步加强鼓励仿制药品目录政策执行时的政府部门间合作。 |
| 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. |
| 期刊： | 2021年第32卷第17期 |
| 作者： | 王圣鸣，田侃#，王紫红 |
| AUTHORS： | WANG Shengming，TIAN Kan，WANG Zihong |
| 关键字： | 鼓励仿制药品目录；政策；专利；仿制药 |
| KEYWORDS： | Encouraged generic drug catalogue ；Policy；Patent；Generic drug |
| 阅读数： | 231 次 |
| 本月下载数： | 7 次 |
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