EMA LAYS DOWN STANDARDS FOR NON-EU CLINICAL TRIALS
April 1st, 2012
BY KEITH NUTHALL
THE EUROPEAN Medicines Agency (EMA) has laid down ethical and good clinical practice principles it requires for pharmaceutical trials undertaken outside the European Union (EU). 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 affects the rights, safety or well-being of the subjects or the quality and integrity of the data ...
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