欧美原料药注册管理制度介绍

An introduction to the registration management system for drug substances in the EU and USA

原料药是化学药物制剂中最重要组成部分,为了方便业界更好理解国内外药品监管当局对于原料药的注册管理情况,本文系统介绍了欧盟和美国的原料药注册管理制度及其最新发展状况。欧洲药典专论适用性证书程序的权威性和接受度都很高,但需要以欧洲药典为基础。药物主文件(DMF)和活性物质主文件(ASMF)是2种广泛应用的程序,在平衡原料药生产商、制剂生产商利益和满足官方审核要求方面发挥了较大的作用。完整性审核方式以及活性物质主文件评估工作共享程序,可以有效提高文件质量,加快药品审评进程;电子通用技术文件在提高审评速度和效率方面效果明显。欧盟和美国的原料药注册管理制度对我国原料药的注册管理具有重要的参考意义。

Drug substances are the most important components in drug products. To facilitate the understanding of relevant domestic and overseas information,the registration management systems for drug substances in the EU and USA,were systematically introduced as well as its state of development. The certification of suitability to the monographs of the European pharmacopoeia（ CEP or COS） procedure has good authority and acceptability,but it is limited to substances adopted in European pharmacopoeia only. The drug master file（ DMF） and active substance master file（ ASMF） are two widely used procedures,which play huge function in balance the interest of drug substance manufacturers and drug products manufacturers as well as the requirements from drug authority. The completeness assessment for DMF and worksharing procedure for assessment of ASMF,can effectively improve the document quality and promote the evaluation process. The electronic common technical document（ e CTD） has significant influence in improving the rate and efficiency of document evaluation. In general,the registration management systems for drug substances,in the EU and USA,have a vital reference value to the work in China.