EU OMBUDSMAN SAYS EMA MUST RELEASE TEST ADVERSE REACTION REPORTS

BY KEITH NUTHALL THE EUROPEAN Medicines Agency (EMA) has come under pressure from the European Ombudsman to release information held on adverse reactions to drugs in trials. The official, Nikiforos Diamandouros, has said EU rules on releasing information associated with its decision-making "apply to all documents held by EMA". He noted: "EMA plays a crucial role in the approval and monitoring of medicines placed on the market. Since its work has a direct impact on the health of European citizens, it is of utmost importance for EMA to give the ...


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