European Medicines Agency says Clinical Trials Regulation opens up a new era
Will ensure that Europe remains an attractive centre for clinical research, says Agency
The European Medicines Agency (EMA) welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (EU).
This legislation will open up a new era for the conduct of clinical trials in the EU, ensuring that Europe remains an attractive centre for clinical research, the Agency said. It will also 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 authorisation to the publication of results.
While authorisation and oversight of clinical trials remains the competence of EU members, the new legislation mandates the Agency to prepare the IT platforms to support sponsors and experts in those countries in carrying out their roles in relation to the authorisation of trials, their supervision, safety reporting and compliance activities, as well as to enable public access to information on clinical trials.
The Agency says the new Regulation provides for the first time a direct legal basis for the release of clinical trial results. This is directly in line with its commitment to increased transparency of these data, through its draft policy on proactive publication and access to clinical trial data. This policy, currently in the process of being finalised, will provide a bridge until the new legislation comes into force, which can be no earlier than June 2016.
In drafting its policy, the Agency has carried out a broad public consultation, taking stock of the diverse views that were expressed. In the current absence of a specific legal framework for the release of clinical trial data as soon as the authorisation procedure on a new medicine has been finalised, 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.
The Agency recently completed a last round of targeted consultations and the final policy is to be presented to the EMA's Management Board next month.