New Good Clinical Practices Regime

By means of ANMAT Regulation 7516/2025, published in the Official Gazette on October 9, 2025, the Argentine Agency of Medicines, Food, and Medical Technology (ANMAT) introduced a comprehensive new framework regarding Good Clinical Practices (GCP) and the procedures for assessing and overseeing clinical pharmacology studies conducted for regulatory purposes. This measure aims to update and align the Argentine regulatory framework with the international standards set forth by the International Council for Harmonization (ICH).

This Regulation became enforceable on December 1, 2025, thus repealing ANMAT Regulation 6677/2010 and other complementary regulations and circulars. All regulatory filings still pending resolution continue to be governed by the previous framework.

The implementation of this new framework represents a structural update of the federal system for the assessment and oversight of clinical pharmacology studies in Argentina. It also seeks to facilitate the country’s participation in international research protocols and to streamline regulatory processes, promoting transparency and quality in clinical studies.

The regulation applies to clinical pharmacology studies conducted for registration purposes or to those that—also for regulatory purposes—assess new indications, concentrations, pharmaceutical forms, dosages, or other post-marketing changes that require clinical evidence. 

The Regulation applies to phase I, II, and III studies, and protocol phase variations with registration purposes. Bioequivalence and bioavailability studies, non-interventional studies, and any other studies not intended for registration are expressly excluded from it.