On October 8, 2025, the National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – “ANMAT”) issued new Provision No. 7516/2025 (hereinafter, the “Provision”), approving the Regulations on Good Clinical Practices, Evaluation, and Oversight of Clinical Pharmacology Studies for registration purposes, thereby establishing a comprehensive and updated framework for pharmacological clinical research at the national level.
The Provision approves a set of five technical annexes that form an integral part of the regulation, setting out the requirements, procedures, and standards applicable to the planning, conduct, evaluation, and oversight of clinical pharmacology studies. It also incorporates a Glossary of Terms of general application, with the aim of unifying conceptual criteria and facilitating the correct interpretation and application of the approved provisions.
Among the key aspects of the regulation is the adoption of the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (ICH E6), version R3, as the governing standard for pharmacological clinical trials conducted for registration purposes. This international framework must be complemented by the local regulatory requirements established by ANMAT, thereby consolidating a harmonized regulatory scheme aligned with international best practices, while taking into account the specific features of the Argentine regulatory system.
The scope of application of the Provision covers clinical pharmacology studies conducted for registration purposes, as well as studies carried out on already registered medicinal products when their purpose is to evaluate, for registration purposes, a new indication, a new strength higher than the approved one, a new dosage regimen, a new pharmaceutical form, or other post-registration modifications that require evidence derived from clinical trials. The regulation applies to Phase I, II, and III studies, including protocol phase variations for registration purposes.
Bioequivalence and bioavailability studies are expressly excluded from this regime and continue to be governed by specific ANMAT regulations, as are non-interventional studies and those conducted without registration purposes. In all covered cases, sponsors must obtain prior authorization from ANMAT before initiating the studies, in compliance with the requirements set forth in the Provision.
The regulation grants broad powers to the Directorate of Clinical Research and Management of the Medicinal Products Registry with respect to the authorization, monitoring, and oversight of clinical pharmacology studies. These powers include the evaluation of protocols and amendments, the issuance of technical reports, the authorization of investigators and centers, the management of clinical study databases, the analysis of safety information, the conduct of inspections, the adoption of corrective and preventive measures, the suspension of studies due to non-compliance, and the convening of advisory committees of experts, among other functions aimed at ensuring compliance with Good Clinical Practices and the protection of research subjects.
The Provision expressly repeals a set of prior ANMAT regulations and circulars governing this matter, consolidating the applicable regime for clinical pharmacology studies conducted for registration purposes into a single regulatory body.
This regulation entered into force on December 1, 2025, and provides for a transitional regime for proceedings pending resolution, which will be assessed in accordance with the repealed regulations.
