European Medicines Agency Watch [to 31 May 2014]
http://www.ema.europa.eu/ema/

European Medicines Agency welcomes publication of the Clinical Trials Regulation
28/05/2014
Excerpt
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. 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 authorisation to the publication of the results of those clinical trials.
Whilst authorisation and oversight of clinical trials remains the competence of Member States, the new legislation mandates the Agency to prepare the IT platforms to support sponsors and experts in the Member States 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.
EMA policy on publication and access to clinical trial data
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 the Agency’s 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 mid-2016.