Todić Maida
Institute of Pharmacology, Clinical Pharmacology and Toxicology Pavel Stern, Faculty of Medicine, University of Sarajevo.
Bosn J Basic Med Sci. 2003 Mar;3(1):56-60. doi: 10.17305/bjbms.2003.3572.
Extensive and complete documentation must be presented for marketing authorization of a medicinal product in the EU. Presented documentation should prove quality, safety and efficacy of the medicinal product. It is ensured that the applicant supplies the authorities with complete information. The legislation in Federation of Bosnia and Herzegovina has also taken more steps towards those European directions. The presentation and content of the dossier in the European Union has been redefined. The "old" EU format will be replaced with the Common Technical Document (EU CTD format) agreed in 2000, within the International Conference on Harmonization framework. These two formats are intended to coexist during the transition period until July 2003. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan.
在欧盟，必须提交详尽且完整的文件以获得药品上市许可。所提交的文件应证明药品的质量、安全性和有效性。要确保申请人向当局提供完整信息。波斯尼亚和黑塞哥维那联邦的立法也朝着这些欧洲方向采取了更多措施。欧盟药品档案的呈现方式和内容已重新界定。“旧”的欧盟格式将被2000年在国际协调会议框架内商定的通用技术文档（欧盟CTD格式）所取代。在2003年7月之前的过渡期内，这两种格式将同时存在。CTD是一种国际商定的格式，用于编写结构良好的申报文件，以便提交给欧洲、美国和日本这三个国际协调会议（ICH）地区的监管当局。
