Abstract
The purpose of this study was to analyze Moroccan regulations on bioequivalence studies and compare them with some international guidelines. It emerged that, as most common guidelines, Moroccan regulations treated essential questions relating to the conduct of bioequivalence studies while remaining general. An effort to harmonize the Moroccan regulations as closely as possible with international guidelines such as European Medicines Agency and World Health Organization was made. The decree 2-12-198 on bioequivalence studies includes worldwide gold standards such as inclusion and exclusion criteria, study design, choice and number of subjects, conduct of the study, pharmacokinetic parameters, BE acceptance criteria, and biowaiver requirements. It specifically addresses issues such as pro-drug, metabolites, urinary samples, and endogenous substances. Specific precisions such as the case of the modified release forms, the replacement of subjects on the withdrawal, or drop-out of a volunteer are not covered by this general decree and should be part of new directives, in the future. For an emerging country, the integration of Biopharmaceutics Classification System biowaivers within the decree confirms the efforts being made by the Moroccan regulations to join the most advanced guidelines on the investigation of bioequivalence and to prepare the International Council on Harmonisation M9 adoption.
Highlights
Generic drugs are expected to be bioequivalent and interchangeable with the original product (WHO, 2016), as they exhibit the same efficacy and safety, for the same dose, and a similar form
The integration of Biopharmaceutics Classification System biowaivers within the decree confirms the efforts being made by the Moroccan regulations to join the most advanced guidelines on the investigation of bioequivalence and to prepare the International Council on Harmonisation M9 adoption
In order to demonstrate this equivalence, it is necessary to perform a specific pharmacokinetic study that demonstrates the similarity of plasma profile, which is used as a surrogate of a clinical study and allows to bridge the efficacy and safety of the generic product to the reference product
Summary
Generic drugs are expected to be bioequivalent and interchangeable with the original product (WHO, 2016), as they exhibit the same efficacy and safety, for the same dose, and a similar form. In order to demonstrate this equivalence, it is necessary to perform a specific pharmacokinetic study that demonstrates the similarity of plasma profile, which is used as a surrogate of a clinical study and allows to bridge the efficacy and safety of the generic product to the reference product. This specific study is called bioequivalence study (WHO, 2016). In Africa, as on other continents, very few countries have imposed bioequivalence as an essential step in obtaining the marketing authorization for generic drugs. The majority of drugs sold are imported from well-established producers (Ngozwana et al, 2012; Paul et al, 2018)
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