New Clinical Trials Regulation for the EU

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-29-2014 18:31


The European Medicines Agency (EMA) reports that the new Clinical Trials Regulation has been published in the Official Journal of the European Union.

"This legislation will open up a new era for the conduct of clinical trials in the EU, ensuring that Europe remains an attractive center for clinical research," said EMA in a press release. "This will foster European competitiveness and innovative capacity and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the regulation foresees transparency on the conduct of trials in the European Economic Area, from the point of their authorization to the publication of the results of those clinical trials."

While the authorization and oversight of clinical trials remains the competence of member states, the new legislation mandates the EMA to prepare the IT platforms to support sponsors and experts in the member states in carrying out their roles in relation to the authorization of trials, their supervision, safety reporting, and compliance activities, as well as to enable public access to information on clinical trials.

The new regulation provides for the first time a direct legal basis for the release of clinical trial results, according to the EMA. EMA says this is directly in line with its commitment to increased transparency of data, through its draft policy on proactive publication and access to clinical trial data. This policy, currently in the process of being finalized, will provide a bridge until the new legislation comes into force, which can be no earlier than mid-2016.

In drafting its policy, EMA carried out a broad public consultation."In the current absence of a specific legal framework for the proactive release of clinical trial data as soon as the authorization procedure on a new medicine has been finalized, the challenge in this exercise was to find a balance between the often competing views that would allow the agency to move forward with its policy," said EMA.

The EMA recently completed a last round of targeted stakeholder consultations and the final policy is to be presented to the EMA's Management Board in June 2014. "The agency believes its policy finds an acceptable balance between all those competing interests. Once implemented, this policy will give all stakeholders the opportunity to learn from this first step while preparing for the regulation to come into force," said EMA

Source: European Medicines Agency


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