Government unifies 36 regulations and modernizes drug bioequivalence requirements
The National Administration of Medicines, Foods and Medical Technology (ANMAT) has approved a new regulatory framework for the bioequivalence of synthetic drugs, consolidating 36 previous regulations into one. This measure aims to update scientific and health requirements to ensure drug quality and safety, streamlining procedures while reducing costs. The new regulations also align local requirements with international standards, allowing studies conducted in Argentina to be used for exports without needing to repeat testing.
By Ministerio de Desregulación
