Exploration and inspiration of orphan drug registration systems at home and abroad
FANG Zhong-jian
LIN Le-ting
WANG Cai-yi
SHEN Chen
ZHANG Liang
WANG Ying-xia
ZHU Si-qi
SHAO Rong
SHAO Ming-li
FAN Yu-lu
Abstract：At present,the registration systems of pediatric orphan drugs in some foreign developed countries are relatively perfect,for example,the US FDA has established the qualification system for orphan drugs.Unlike some developed countries in Europe and the US that have established special regulatory agencies and measures for rare diseases and orphan drugs.In China,the prevention and treatment of rare diseases and registration of orphan drugs have not received sufficient attention and are even marginalized.The orphan drug registration system in China is obviously less developed than those in some developed countries in Europe and the US.This paper presents a comparative analysis of orphan drug registration systems in different countries through a literature review and proposes ways to promote the establishment of an orphan drug registration system in China,taking into account the national conditions of China.
Keywords：new drug research and developmentdrug registrationorphan drugsrare disease
Publication Date：2024-05-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 978-983 )