The AEMPS boosts bioequivalence in Latin America through training

August 7, 2015

In Europe and United States generic drugs are supported by bioequivalence studies that ensure their efficacy and security. Unfortunately, the situation is different in some Latin American countries. In these countries generic drugs legislation is laxer and drugs can be authorised without bioequivalence or only with in vitro bioequivalence studies, also called bioexemption.

Many Latin American countries are adopting changes in their generic drugs legislation in order to get closer to the standards of European or American countries. In order to foster these legislation changes, last June and July the AEMPS, in collaboration with the network EAMI (Iberoamerican Medicines Authorities), organized workshops on the assessment of bioequivalence studies.

Governmental experts from different countries including Peru, Chile, Brazil, Panamá and Costa Rica among other countries, attended to the training sessions where the most relevant issues about bioequivalence were discussed.  The most important aspects were the European and Spanish legislative framework of generic drugs and the Guidelines. Besides, the experts had the chance to review real dossiers of generic drugs.

Through these actions and the interest aroused in Latin American countries it can be predicted that some of these countries will soon adopt new legislative measures in order to ensure the efficacy and safety of generic drugs.