Bioequivalence studies in Morocco

Abstract

The development of the generic drug represents one of the strongest axes of the regulation of drug expenditure. In addition to saving the cost of the medical treatment that it allows, it has other interests. Among other things, the fact that it is among the best tools that will allow the viability and success of basic medical coverage in our country [1]. The law mandated bioequivalence trials in 2006. A decree of the Ministry of Health, effective in June 2012, strengthened the law, recalling the legal obligation to demonstrate the bioequivalence of a generic drug with its brand-name drug, before granting marketing authorization for any generic drug manufactured locally or imported. It established the cases where bioequivalence studies are required, the cases justifying the dispensation of bioequivalence studies and provided a precise definition of the notion of bioequivalence, bioavailability and that of the brand-name drug [2]. Since then, the first bioequivalence center authorized by the Ministry of Health has been created in September 2015. Pharmaceutical manufactures have so far been studying bioequivalence abroad, particularly in Jordan, France, Egypt and India. This center will allow Moroccan industrialists to follow directly the progress of the studies and a cost saving, this one is lower of 20% than abroad. It will also allow them to benefit from a service offering quality and proximity [3]

Keywords

• generic drugs
• bioequivalence
• morocco
• legislative texts
• clinical trials