EMA lays down standards for non-EU clinical trials
Shortcomings should lead to the rejection of trial data presented in market approval applications
The European Medicines Agency (EMA) has laid down ethical and good clinical practice principles it requires for pharmaceutical trials undertaken outside the European Union.
In a reflection paper, it stressed that these should meet EU standards. And it outlines shortcomings that it says should lead to the rejection of trial data, should it be presented to EU regulators in market approval applications. Poor practices that 'significantly affect 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,' said the paper.
It added that any data generated from a clinical trial whose protocol was not submitted to an independent ethics committee should be disregarded, along with information from trials conducted without the informed consent of subjects. The paper said pharmaceutical companies should provide EU regulators with information summarising a non-EU trial and its ethical and clinical standards.