Influence of Chemical Drug Registration Reform on Pharmaceutical Industry in China
- VernacularTitle:化学药品注册改革对我国医药行业的影响研究
- Author:
Xiaohuan LI
;
Xinyue XU
;
Shuang DU
;
Yi LIANG
- Keywords:
Drug registration reform;
Generic drugs;
New drugs
- From:
China Pharmacist
2017;20(2):324-326
- CountryChina
- Language:Chinese
-
Abstract:
Domestic generic drug registration has a large proportion in chemical drugs with outstanding repeated registration phe-nomenon and low level innovation of enterprises. Under the above background, chemical drug registration reform kicked off. The imple-mentation of new drug registration classification, marketing authorization holder and the changes of listed drug registration documents have a huge impact on China' s pharmaceutical industry, which can promote the reformulation of domestic pharmaceutical market, en-courage R&D and innovation in enterprises and accelerate the pace towards the international market.