EU Regulation on Clinical Trials

The GCP (Good Clinical Practice) Regulation 536/2014 of the EU establishes a new authorisation procedure for clinical trials. The ʻEuropean Medicines Agency’ (EMA) which shall support the new procedure with an online portal and a database, lags behind schedule.

Clinical trials can have different designs. They can, for example, examine medicines which are not yet approved for marketing or compare them with others which are already approved. Research in humans must not be started without the consent of regulatory authorities and ethics committees of all countries which are involved in the concerned trial. Up to now, the sponsor of a clinical trial had to submit a separate application for authorisation in each member state, with the different formats, timelines and languages. Each protocol change has to be agreed by all countries involved.

Central instead of national authorisation

The EU GCP Regulation establishes a new authorisation procedure. It replaces the separate national authorisations by the concept of mutual recognition. This means that in the future one application per trial within the EU will be sufficient. The pharmaceutical manufacturer submits one application to all EU Member States in which clinical trial sites are located (clinics or medical practices) via the central online portal of the EMA. The assessment of the application is then performed by the competent authorities and ethics committees of the respective countries. Ultimately the manufacturer receives one final authorisation. Pursuant to the regulation, the implementation of the new rules is linked to the operability of the portal and the database at the EMA. According to information given by the EMA this will be assured on October 2018 at the latest.

Delay allows more time for implementation

The concept of mutual recognition creates common standards for authorisation procedures of clinical trials in the EU. The project, however, lags behind schedule. Despite this facilitation of the procedure, commercial sponsors and competent authorities deem the delay not purely negative: it gives all stakeholders more time to get prepared for the new workflows. And to get prepared for the fact that for a period of three years the newly organized processes must be run in parallel to the previous ones, requiring enormous effort from all stakeholders. The EMA also envisages disclosing significant contents of the database on clinical trials to the public. The pharmaceutical associations criticize this intention because it deprives the manufacturers of their data sovereignty. This may cause major problems for larger companies whose data are normally indirectly protected by patents or protection certificates. Smaller companies, however, who tend to engage in the improvement of known active substances with expired patent protection, for example in the optimisation of the route of administration or a new presentation, see their work surrendered to competitors without any protection.

BAH is directly involved in the development of the portal and the database via its European umbrella organization, the ‘Association of the European Self-Medication Industry’ (AESGP). Together with the EMA, the national competent authorities and other industry associations, BAH engages actively in the design of the contents and concepts for implementation of the legal requirements.

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