Regulation on clinical trials on medicinal products for human use

On 2 April 2014, the European Parliament finished the first reading and published its legislative resolution on the proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC. Since a provisional agreement between the parliament and the council on the final act has already been achieved, it can be expected that there will be few objections by the council for the final version of the regulation.

The legislative procedure began with a proposal of the European Commission on 17 July 2012. According to the commission, clinical trials are an indispensable part of clinical research, which, in turn, is essential to develop medicinal products and improve medical treatment. Directive 2001/20/EC aimed to simplify and harmonise the administrative provisions governing clinical trials in the European Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. For pharmaceutical companies, it is particularly difficult to perform a clinical trial in several member states. Therefore, the number of applications for clinical trials has fallen whereas the costs for conducting clinical trials have increased in the last few years. The new regulation is intended to solve these problems and set the global gold standard for transparency in clinical trials.

The scope of the proposed regulation is essentially identical to that of Directive 2001/20/EC. The scope is limited to clinical research on medicinal products, but it is very wide in that it only excludes clinical studies that do not involve an intervention (e.g. surveys among medical practitioners without additional intervention). For non-interventional studies that are post authorisation, safety studies initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed by the competent authority for marketing authorisations, the rules are set out in Directive 2001/83/EC…

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