New European policy – greater transparency and access to data from drug regulator | Speaking of Medicine

"The European Medicines Agency (EMA – the public body carrying out the centralised review and approval of new medicines across Europe) has announced a new policy promising greater openness and transparency with regard to its decision making process. Details of the policy are available online. This policy applies to all “business related documents” which are part of the agency’s activities (with some exceptions), and this includes making publicly available data resulting from clinical trials which were included as part of a marketing application to the agency. Importantly, this policy will include making publicly available data from trials for drugs which were declined marketing approval...."