Copenhagen Trial Unit-CTU, Centre for Clinical Intervention Research, and the Danish Clinical Research Infrastructures Network-DCRIN, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Trials. 2012 Mar 27;13:27. doi: 10.1186/1745-6215-13-27.
In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.
We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries.
Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised.
The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.
为了便于多国临床研究，监管要求需要国际化和协调一致。欧盟于 2004 年出台了指令 2001/20/EC，对欧洲的研究性药品进行监管。
我们进行了一项调查，以确定欧洲十个临床研究基础设施网络（ECRIN）国家（奥地利、丹麦、法国、德国、匈牙利、爱尔兰、意大利、西班牙、瑞典和英国）的主要临床研究类别所需的国家监管要求，这些国家约占欧盟人口的 70%。在这里，我们描述了这十个国家典型研究性药品的监管要求的结果。
我们的结果表明，这十个国家对典型研究性药品的定义相当协调一致。评估典型研究性药品的临床试验需要在调查的十个国家中的每个国家获得国家主管当局的授权。主管当局的意见在相同的时间内传达给试验赞助商，即在十个国家中均不超过 60 天。向不同国家发送申请的主管当局并未完全协调一致。
指令 2001/20/EC 定义了“研究性药品”一词，其中所有监管要求均适用于研究性药品。然而，我们的调查显示，这些要求已在十个欧洲国家中被采纳，但并非针对所有研究性药品，而是我们称之为“典型”研究性药品的更窄类别。其结果是对要求进行了部分欧盟协调，并为赞助商提供了一个相对可导航的典型研究性药品领域。
