EMA strengthens Oversight on Clinical Trials outside EU
The European Medicines Agency published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities.
The paper became effective on 1 May 2012 - with the goal to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted.
The reflection paper includes the following actions:
Non-compliance that significantly affects the rights, safety or well-being of the subjects or the quality and integrity of the data reported is not acceptable, and will result in rejection of data and/or other regulatory actions;
Any data generated from a clinical trial for which the protocol was not submitted to an independent ethics committee should be disregarded when evaluating a marketing authorisation application;
Any data generated from a clinical trial conducted without the informed consent of the trial subjects (or their legal representative where that is foreseen) should also be disregarded;
As part of their applications for marketing authorisations, pharmaceutical companies should provide EU regulators with information summarising the conduct of the trial and its compliance with ethical and GCP standards;
The public assessment report should describe the assessment of the compliance with ethical and GCP standards.