Regulación de fitoterapéuticos a nivel nacional e internacional: Estudio comparativo de los marcos regulatorios que rigen los medicamentos herbales en Ecuador y en otras jurisdicciones (OMS, EMA, FDA). Revisión exhaustiva

Abstract

Abstract: Introduction: The regulation of herbal medicines faces the challenge of scientifically validating complex and heterogeneous plant matrices. In Ecuador, informal commercialization and microbiological quality deficiencies persist as critical public health challenges. General Objective: To compare the regulatory framework of the National Agency for Health Regulation, Control, and Surveillance (ARCSA) with international guidelines from the WHO, EMA, and FDA to identify opportunities for technical and regulatory strengthening. Methodology: A study with a qualitative approach and an analytical-comparative scope. A bibliographic and regulatory systematization matrix was used to triangulate quality, safety, efficacy, and pharmacovigilance requirements from reference agencies against current Ecuadorian legislation. Results: ARCSA maintains a rigorous document-based registration protocol focused on the finished product under Climatic Zone IV conditions. However, significant disparities were found compared to the international model, which regulates starting from the agricultural stage (GACP guidelines) and implements advanced analytical tools such as chromatographic fingerprinting. Furthermore, local pharmacovigilance is reactive and suffers from high under-reporting rates, unlike the mature, proactive systems of the EMA and FDA (MedWatch). Conclusions: The local regulatory gap stems from the absence of controls in the agricultural supply chain and a lack of high-resolution methodologies, facilitating the proliferation of the informal market. It is imperative to update ARCSA regulations to align with international standards, promote active pharmacovigilance, and create simplified registration pathways based on safety history to inclusively regulate traditional ancestral medicine.