إجراء مقترح من تشيلي: الأدوية واللقاحات

Technical Guide G-BIOF 03 will form a new annex to Technical Standard No. 131, which defines the criteria for establishing therapeutic equivalence in pharmaceutical products in Chile. It will provide guidelines for demonstrating therapeutic equivalence in oral dosage forms acting locally in the gastrointestinal tract, thereby addressing a regulatory need for those products where traditional plasma bioequivalence studies are not applicable.This guide was drawn up on the basis of the standards and recommendations of the European Medicines Agency and the United States Food and Drug Administration, thereby expanding the methods available for demonstrating therapeutic equivalence through robust designs and rigorous methodologies, which are expected to facilitate international regulatory recognition.