Status quo and improvement countermeasures of the priority review system for encouraged generic drug  in China

SUN Xuli; MA Shaoqing

doi:10.6039/j.issn.1001-0408.2023.02.01

您当前的位置：

首页 >

文章列表页 >

Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China

更新时间：2023-02-22

- Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China
- ZHONGGUO YAOFANG Vol. 34, Issue 2, Pages: 129-132(2023)
- 作者机构：
  
  北京中医药大学人文学院，北京　102488
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.02.01
  CLC： R951
- Published：30 January 2023，
  
  Received：24 August 2022，
  
  Revised：25 December 2022，
扫描看全文
孙旭丽,马韶青.我国鼓励仿制药品优先审评制度的现状及完善对策 ^Δ[J].中国药房,2023,34(02):129-132.

SUN Xuli,MA Shaoqing.Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China[J].ZHONGGUO YAOFANG,2023,34(02):129-132.
孙旭丽,马韶青.我国鼓励仿制药品优先审评制度的现状及完善对策 ^Δ[J].中国药房,2023,34(02):129-132. DOI： 10.6039/j.issn.1001-0408.2023.02.01.

SUN Xuli,MA Shaoqing.Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China[J].ZHONGGUO YAOFANG,2023,34(02):129-132. DOI： 10.6039/j.issn.1001-0408.2023.02.01.

摘要

目的

为更好地落实鼓励仿制药品目录内仿制药的优先审评制度提供参考。

方法

在文献研究的基础上，分析我国2批鼓励仿制药品目录内仿制药实施优先审评的现状，对照该制度在适用中存在的问题，提出相应的解决方案。结果与

结论

我国共发布2批鼓励仿制药品目录，纳入目录的仿制药有49个品种。我国鼓励仿制药品目录内仿制药的优先审评在立法、首仿药激励、上市后再评价、跨部门协调联动等方面存在一定的不足。建议我国可以从加强立法、完善“首仿药市场独占期”制度、健全仿制药上市后的再评价制度、建立常态化的跨部门协调机制等方面进行完善，从而保障我国仿制药的安全、有效和可及。

Abstract

OBJECTIVE

To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues.

METHODS

Based on literature research， practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed， and the problems existing in the application of the system were compared to propose corresponding solutions.

RESULTS &CONCLUSIONS

China has issued two batches of encouraged generic drug catalogues， and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues， there were some problems in legislation， incentive system for the first generic drug， post-marketing re-evaluation system， and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation， improve the “first generic market exclusivity period” system， perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety， effectiveness and accessibility of generic drugs in China.

关键词

仿制药鼓励仿制药品目录优先审评制度完善对策

Keywords

encouraged generic drug cataloguespriority review systemimprovement countermeasures

references

王圣鸣，田侃，王紫红. 我国鼓励仿制药品目录政策趋势研究[J]. 中国药房，2021，32（17）：2053-2058.

孙搏，陈桂良，宁黎丽. 美国FDA橙皮书的介绍及启示[J]. 中国医药工业杂志，2021，52（11）：1522-1528.

王圣鸣，田侃，文庆，等. 中国第一批鼓励仿制药品目录的纳入品种分析[J]. 卫生经济研究，2020，37（7）：26-30.

CHAHAL H S，FOWLER A C，PATEL R，et al. Characte- ristics and outcomes of products seeking competitive generic therapy designation and exclusivity[J]. JAMA，2021，326（18）：1863-1865.

孙迎春. 国外政府跨部门协同机制及其对中国的启示[J]. 行政管理改革，2013（10）：63-67.

ZHANG L，LIONBERGER R A. Generics 2030：where are we heading in 2030 for generic drug science，research，and regulation?[J]. Clin Pharmacol Ther，2020，107（6）：1293-1295.

LIETZAN E，POST J. The law of 180-day exclusivity[J]. Food Drug Law J，2016，71（3）：327-400.

DARROW J J，AVORN J，KESSELHEIM A S. FDA approval and regulation of pharmaceuticals，1983-2018[J]. JAMA，2020，323（2）：164-176.

NGUYEN N X，SHEINGOLD S H，TARAZI W，et al. Effect of competition on generic drug prices[J]. Appl Health Econ Health Policy，2022，20（2）：243-253.

TAKAMI A，HIRATA K，ISHIGURO C，et al. Lower proportion of spontaneous adverse event reports for generic drugs by comparison with original branded drugs at the postmarket stage in Japan[J]. Clin Pharmacol Ther，2019，105（6）：1471-1476.

王丽，王晓墨，杨晨露. 基于医疗大数据开展药品上市后监测与评价研究的偏倚及其控制[J]. 中国药物警戒，2022，19（3）：239-243.

GAGNE J J，SARPATWARI A，DESAI R J. Role of authorized generics in postapproval surveillance of generic drug products[J]. Clin Pharmacol Ther，2019，105（2）：313-315.

马英娟. 走出多部门监管的困境：论中国食品安全监管部门间的协调合作[J]. 清华法学，2015，9（3）：35-55.

朱春奎，毛万磊. 议事协调机构、部际联席会议和部门协议：中国政府部门横向协调机制研究[J]. 行政论坛，2015，22（6）：39-44.

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

No data

Related Author

No data

Related Institution

No data

Address：8/F,129 Daping Main Street,Yuzhong District,Chongqing 400042,P.R.China
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰