''Regular Pharmacovigilance Reports (RPR) are applied to all drugs under health surveillance. However, new drugs (new molecular entities synthetic, semi-synthetic vaccines and biotechnology) are of particular interest to pharmacovigilance, because when a new product is submitted for approval of registration, proof of its effectiveness and evaluation of their security are based on studies with a small number of patients. The limited number of study subjects included in the clinicai sample, the cutting, at least initially, of some patients at risk, the deficiency of long lasting treatment and the impossibility of concomitant therapies don't allow an ideal evaluation of the safety profile."

(Texto adaptado do Guia de Farmacovigilância -Anvisa ANEXO li - Relatório Periódico de Farmacovigilância (RPF). Brasília, 2009)

Among the new medicines of special interest to pharmacovigilance may be mentioned, except: