WTO notification · TBT
ChileProposed measure, not in force yet
Guide G-BIOF 03: Guide for the demonstration of bioequivalence of oral pharmaceutical forms with local action in the gastrointestinal tract
Guía G-BIOF 03: Guía para la demostración de bioequivalencia de formas farmacéuticas de administración oral con acción local en el tracto gastrointestinal
Chile notified this proposed TBT measure to the WTO on 10 August 2026. The comment period closed on 9 October 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Medicamentos (Medicamentos)
Medicamentos
The comment period closed on 9 October 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CHL/803; it can take them up with Chile.
Find your country's enquiry point on WTO ePing (opens in a new tab)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.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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