New Good Clinical Practice Regulations for Clinical Pharmacology Studies in Argentina
The National Administration of medicines, Food and Medical Technology (ANMAT) has announced new regulations regarding Good Clinical Practices (GCP) for clinical pharmacology studies intended for registration purposes in Argentina. the changes, detailed in Provision No. 7516/25 published on October 9, 2025, modernize and strengthen the evaluation, authorization, and supervision of these studies.
The new regime adopts the Good Clinical Practice Guide established by the International Council for Harmonization (ICH) E6, version R3, aligning Argentina with internationally accepted standards for the planning, execution, monitoring, and reporting of clinical trials. This adoption aims to ensure the protection of research participants and the reliability of collected data. The regulations also outline specific local requirements and procedures for conducting clinical pharmacology studies within Argentina.
These updated regulations will come into effect on december 1st, 2025, and apply to all Phase I, II, and III clinical pharmacology studies evaluating new indications, higher concentrations, new dosages, new pharmaceutical forms, or any post-registration modifications requiring clinical data.
ANMAT states the update is designed to improve the safety of research subjects, reinforce data traceability, and promote the ethical, technical, and scientific advancement of clinical studies in the country. This move is a direct result of ANMAT’s recent progress in regulatory harmonization and increased involvement in international forums.
Argentina’s designation as a Regional Reference regulatory Authority in 2017 and its subsequent full membership as a regulatory member of the ICH in 2024 necessitated the alignment of national regulations with global standards. This will facilitate greater participation in international research, streamline regulatory processes, and enhance transparency and quality in clinical studies.
ANMAT anticipates the regulatory update will lead to a basic advancement in public health, increased quality of treatment standards, and greater protection for individuals participating in research.
Further facts is available on the official government website: https://www.argentina.gob.ar/noticias/nueva-normativa-sobre-buenas-practicas-clinicas-para-estudios-de-farmacologia-clinica.
