Motola Domenico, De Ponti Fabrizio, Rossi Pasqualino, Martini Nello, Montanaro Nicola
Department of Pharmacology and Interuniversity Research Centre for Pharmacoepidemiology, University of Bologna, Bologna, Italy.
Br J Clin Pharmacol. 2005 Apr;59(4):475-8. doi: 10.1111/j.1365-2125.2004.02320.x.
Since January 1995, all European Union applications for marketing approval for medicinal products derived from biotechnology and other drugs considered potentially innovative follow the EMEA centralized procedure. In order to assess the overall degree of therapeutic innovation of these drugs, we considered, for each approved agent, its target, the availability of previous treatments and the extent of its therapeutic effect. The following scores for therapeutic innovation were assigned through a consensus process: 'A' (important), 'B' (moderate) and 'C' (modest). The overall degree of important/moderate therapeutic innovation was 47% of all therapeutic agents (32% important; 15% moderate). Most (80%) of the EMEA-approved therapeutic agents were for serious diseases. The remaining ones were for risk factors (7%) or nonserious diseases (13%).
自1995年1月起，所有欧盟关于源自生物技术的药品以及其他被视为具有潜在创新性的药物的上市许可申请均遵循欧洲药品管理局（EMEA）的集中程序。为了评估这些药物的总体治疗创新程度，对于每一种获批药物，我们考量了其靶点、既往治疗方法的可及性以及治疗效果的程度。通过共识过程赋予了以下治疗创新分数：“A”（重要）、“B”（中等）和“C”（适度）。重要/中等治疗创新的总体程度占所有治疗药物的47%（重要的占32%；中等的占15%）。欧洲药品管理局批准的大多数（80%）治疗药物用于治疗严重疾病。其余的用于风险因素（7%）或非严重疾病（13%）。
