欧盟批准的新植物药桦树皮凝胶的审评思路  

Analysis of European Medicines Agency assessment consideration on the new herbal medicinal product Episalvan gel

作　　者：关宏峰 刘炳林 GUAN Hong-feng;LIU Bing-lin(Center for Drug Evaluation National Medical Products Administration,Bejing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2021年第4期490-496,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：以欧洲药品管理局第一个按照集中审评程序批准的新植物药桦树皮凝胶作为案例,详细介绍了欧盟植物药申请类别及药学和临床研究申报资料要求,从而为我国天然药物研发、技术审评以及审评报告的公开等提供参考。Episalvan gel is the first new herbal medicinal product approved under the centralized procedure by Europe medicine agency, this article is intended to take it as an example to investigate the application category of herbal medicinal product in Europe as well as its requirements on application dossier of chemistry, manufacturing and controls and clinical trial, with the aim of providing reference to the research & development, technical review and public assessment reports of natural medicinal product in China.

关 键 词：欧洲药品管理局 新植物药 桦树皮凝胶 审评思路 审评报告公开 

分 类 号：R28[医药卫生—中药学]