The Reform of the Orphan Drug Assessment System in China

被引：1
作者：
Wang, Xiangyu [1 ]
Wang, Lin [2 ]
Zheng, Xiaoying [3 ,4 ]
Zheng, Qiang [5 ,6 ]
机构：
[1] Natl Med Product Adm, Dept Sci, Technol & Int Cooperat, Beijing 100027, Peoples R China
[2] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD 21202 USA
[3] Peking Univ, Inst Populat Res, Beijing 100871, Peoples R China
[4] Peking Univ, APEC Hlth Sci Acad HeSAY, Beijing 100871, Peoples R China
[5] Peking Univ, Dept Ind Engn & Management, Coll Engn, Beijing 100871, Peoples R China
[6] Peking Univ, Ctr Pharmaceut Informat & Engn Res, Beijing 100871, Peoples R China
来源：
JOURNAL OF PHARMACEUTICAL INNOVATION | 2022年 / 17卷 / 03期
关键词：
Orphan drug; Rare disease; Regulation; China;
D O I：
10.1007/s12247-021-09560-7
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
This perspective article provides historical background and current considerations of the regulation of rare diseases and orphan drugs in China, presenting the ongoing reform of the orphan drug assessment system in the context of a maze of seemingly convoluted government agencies and regulatory policies that are unique to the fast developing China.
引用
收藏
页码：1062 / 1068
页数：7
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