Análisis comparativo de normativas internacionales (EMA, FDA y ARCSA), con respecto a la bioequivalencia, frente al uso de medicamentos genéricos

Abstract

Abstract: Bioequivalence is a fundamental criterion for establishing comparability between generic medicines and their reference products. The objective of this study was to compare the technical and regulatory criteria established by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Ecuador s National Agency for Health Regulation, Control and Surveillance (ARCSA) for demonstrating the bioequivalence of generic medicines, in order to identify similarities, differences, and opportunities to strengthen the Ecuadorian regulatory framework. The study was designed as descriptive and comparative documentary research. To this end, a systematic search of official regulatory sources and available scientific literature was conducted, and the information was subsequently organized using an analytical matrix of bioequivalence requirements. The evaluation considered pharmacokinetic parameters, experimental designs, statistical thresholds, biowaiver criteria, and the documentation required by the three regulatory agencies. The results confirmed a high degree of consistency in the scientific principles underlying the demonstration of bioequivalence, particularly regarding the assessment of Cmax and AUC, the use of a 90% confidence interval, and the commonly accepted range of 80.00 125.00%. The most notable differences were not found in the core scientific principles, but rather in the scope, organization, and operational requirements of regulatory submissions. In conclusion, Ecuador s regulatory framework is broadly consistent with the current scientific standards applied by internationally recognized regulatory agencies; however, opportunities for improvement were identified, particularly regarding the updating of the legal framework, greater specificity of methodological criteria, and improved access to regulatory information.