gms | German Medical Science

The new regulation is particularly set up to harmonize the approval process for clinical trials in the EU and to make sure that the results of the studies are rapidly generally available (as well as detailed information about it). This new regulation should apply to all studies by pharmaceutical companies as well as for academic studies that are initiated by physicians.

The main change from this new regulation will affect the approval process prior to the study. In future it should be sufficient to generate only one central application for the EU per study. This application is submitted by the sponsor over an online portal of the EU – along with a list of EU countries in which the study will take place. The further processing of the application by the regulatory authorities and the country-specific ethics committees is then organized to result in a joint assessment by all involved EU member states – including the official approval by the competent authority and the assessment of at least one ethics committee received from all Member States. This new EU-wide approval process and other approaches coming of the new EU regulation will be presented and explained in its basic details.