Practice of the Qualification and Recognition for Orphan Drugs in the World and its Inspiration
10.12376/j.issn.2097-0501.2022.03.018
- VernacularTitle:罕见病药品资格认定的国际实践与启示
- Author:
Xiaohong ZHU
1
;
Shunping LI
1
;
Jingdan CHEN
1
;
Junchao FENG
1
;
Haiqin ZHANG
1
;
Jiaqi LIU
1
;
Shiyao XIE
1
;
Yue ZHANG
1
Author Information
1. Centre for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, NHC Key Lab of Health Economics and Policy Research, Center for Health Preference Research, Shandong University, Jinan 250012, China.
- Publication Type:Journal Article
- Keywords:
rare diseases;
orphan drugs;
qualification and identification;
orphan drugs supervision
- From:
JOURNAL OF RARE DISEASES
2022;1(3):339-346
- CountryChina
- Language:Chinese
-
Abstract:
We have analyzed the current status of recognization and qualification of orphan drugs in China and abroad, looking at the aspects of the authority institutions, identification and qualification process, and the number of orphan drugs identified and available in the market. By comparing and analyzing horizontally the differences in orphan drugs identification between representative developed countries vs. some developing countries, we discuss the inadequacy of orphan drugs supervision in China. We introduce the advanced experience from the developed countries and some developing countries to provide suggestions for the identification and management of orphan drugs, hoping to speed up the process of development and market availability of orphan drugs and to maximize patient's accessibility to treatment in China.
