摘要
2017年中国药品监管制度经历了前所未有的深刻变革,势必对国内新药研发和技术创新产生深远的影响。本文通过对2017年CFDA批准药品和CDE药品注册申请受理数据的梳理和分析,剖析其中潜在的趋势及成因,以期为政府和企业进行新药研发管理决策及战略制定提供参考。
China＇s drug regulatory system has undergone unprecedented profound changes in 2017, and it is bound to have a far-reaching impact on the research and development of new drugs and technological innovation in China. This paper analyzes the data of approved new drugs from CFDA and drug registration applications from CDE, and try to figure out the potential trends and causes to provide references for government and enterprises to develop new drug management decisions and strategies.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2018年第3期392-396,共5页
Chinese Journal of Pharmaceuticals
关键词
新药研发
注册申报
医药政策
Drug R＆D
drug registration
drug regulatory policy
