ABSTRACT
The purpose of this study was to analyze Moroccan regulations on bioequivalence studies and compare them with someinternational guidelines. It emerged that, as most common guidelines, Moroccan regulations treated essential questionsrelating to the conduct of bioequivalence studies while remaining general. An effort to harmonize the Moroccanregulations as closely as possible with international guidelines such as European Medicines Agency and World HealthOrganization was made. The decree 2-12-198 on bioequivalence studies includes worldwide gold standards such asinclusion and exclusion criteria, study design, choice and number of subjects, conduct of the study, pharmacokineticparameters, 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 releaseforms, the replacement of subjects on the withdrawal, or drop-out of a volunteer are not covered by this general decreeand should be part of new directives, in the future. For an emerging country, the integration of BiopharmaceuticsClassification System biowaivers within the decree confirms the efforts being made by the Moroccan regulations tojoin the most advanced guidelines on the investigation of bioequivalence and to prepare the International Council onHarmonisation M9 adoption