What is the European Medicines Agency?
In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process. The main scientific limitations of this process are highlighted, together with some suggestions for dealing with them.
Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Verona, Italy.
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D017277:Drug Approval / Q000379:methods*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D011634:Public Health / Q000379:methods; D016032:Randomized Controlled Trials as Topic