The notified regulation is the draft Amendment to the Sanitary Technical Regulation establishing the criteria and requirements for demonstrating bioequivalence and bioavailability in medicines for human use and consumption (Resolution ARCSA-DE-015-2018-JCGO).

PROYECTO DE REFORMA A LA NORMATIVA TÉCNICA SANITARIA QUE ESTABLECE LOS CRITERIOS Y REQUISITOS PARA DEMOSTRAR BIOEQUIVALENCIA Y BIODISPONIBILIDAD, EN LOS MEDICAMENTOS DE USO Y CONSUMO HUMANO, RESOLUCIÓN ARCSA-DE-015-2018-JCGO (Draft Amendment to the Sanitary Technical Regulation establishing the criteria and requirements for demonstrating bioequivalence and bioavailability in medicines for human use and consumption (Resolution ARCSA-DE-015-2018-JCGO)) (10 pages, in Spanish)

The notified regulation is the draft Amendment to the Sanitary Technical Regulation establishing the criteria and requirements for demonstrating bioequivalence and bioavailability in medicines for human use and consumption (Resolution ARCSA-DE-015-2018-JCGO).