WTO notification · TBT
ChileProposed measure, not in force yet
Update to Guide G-BIOF 01: 'Guide for conducting comparative bioavailability studies in solid oral pharmaceutical forms with systemic action'.
Actualización Guía G-BIOF 01: 'Guía para la realización de estudios de biodisponibilidad comparativa en formas farmacéuticas sólidas de administración oral y acción sistémica'.
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/801; it can take them up with Chile.
Find your country's enquiry point on WTO ePing (opens in a new tab)The notified guide aims to update the practices and requirements applicable to the conduct and submission of bioequivalence studies on solid oral dosage forms with systemic action, including capsules, tablets, coated tablets, orodispersible tablets, chewable tablets and aqueous suspensions. Furthermore, the guide seeks to review and supplement the concepts set out in the Standard Defining Criteria for Establishing Therapeutic Equivalence of Pharmaceutical Products in Chile (Exempt Decree No. 27/2012), bringing them into line with current international technical guidelines.This regulatory update describes the scientific and technical aspects relating to the design of studies and the analysis of data intended to support the assessment of bioequivalence based on pharmacokinetic variables applicable to solid oral dosage forms.
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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Chile notified this proposed TBT measure to the WTO on 21 October 2026. Comments are open until 20 December 2026.
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