Who checks the quality, safety and efficacy of generic medicines?
All medicines, generics and originals, have to be authorised by the European Medicines Agency (EMA) or by national medicines agencies before they can be marketed in the European Union. To receive marketing authorisation, generics must show bioequivalence to the originator product – that it works in the same way in the patient’s body. The EMA or the national medicines agency assesses the bioequivalence and relies on the dossier of the original medicine as well as the results of the bioequivalence study, to infer the safety and efficacy of the generic drug. When a manufacturer seeks registration of a generic medicine from the EMA, the manufacturer needs to prove that the generic compound is pharmaceutically equivalent to the original brand and through a bioequivalence study, that all pharmacokinetic parameters are comparable to that of the original Generics are subject to the same European procedures as originator products.
