摘要
通过对国内外药用辅料注册申报资料要求的梳理分析,对国家食品药品监督管理总局发布的药用辅料与药品关联审评审批申报资料要求(总局通告2016年155号附件2)进行详细解读,并对相关管理模式、尚需解决的问题以及未来的发展要求提出思考。
Based on summaries and analyses of the contents of application documents of pharmaceutical excipients both in China and some developed countries,the contents of the application dossiers for evaluation and approval of pharmaceutical excipients associated with drug products were interpreted in depth. The administration modes,issues to be solved and future development of industries were also discussed.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第18期2128-2135,共8页
Chinese Journal of New Drugs
关键词
药用辅料
关联审评
申报资料
pharmaceutical excipients
associated evaluation
application dossier
