Thoughts on clinical review of drug registration application for rare diseases
10.13699/j.cnki.1001-6821.2018.19.036
- VernacularTitle:罕见病治疗药物注册申请临床审评中的基本考虑
- Author:
Li-Hua LIU
1
;
Jian-Zhong ZHAO
;
Xiao-Chun ZUO
;
Lin LIN
Author Information
1. 国家药品监督管理局 药品审评中心
- Keywords:
rare disease;
orphan drug;
clinical trial
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(19):2372-2375
- CountryChina
- Language:Chinese
-
Abstract:
Many governments have actively encouraged the development of drug for rare diseases.In recent years, a series of policies has been pub-lished to encourage the research of rare diseases in china , and there are a large number of orphan drugs to apply for clinical trials or approval appli-cations now.This article summarizes the basic questions of clinical re-view in application of drugs for rare diseases , which will provide some references for the research of drugs for rare diseases .
