Crommelin Daan J A, de Vlieger Jon S B, Weinstein Vera, Mühlebach Stefan, Shah Vinod P, Schellekens Huub
Department of Pharmaceutical Sciences, Utrecht University, P.O. Box 80.082, 3508 TB, Utrecht, The Netherlands.
AAPS J. 2014 Jan;16(1):11-4. doi: 10.1208/s12248-013-9532-0. Epub 2013 Sep 25.
In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) and offers a proposal for a globally accepted terminology regarding (non-) biological complex drugs.
在过去十年中，关于生物制品和非生物复杂药物等复杂药物仿制药监管框架发展的讨论引起了广泛关注。所使用的术语远未统一，可能导致对有关市场准入和报销的法律文本、反思文件及指导文件产生多种解读。本文描述了不同全球区域（欧洲、美国、世界卫生组织）相关术语的含义，并就（非）生物复杂药物提出了一个全球通用术语的建议。
