Overview

• ANMAT published Disposición 7516/2025 in the Boletín Oficial on October 9 to update the national regime for registrational clinical studies.
• The rule formally adopts the ICH Good Clinical Practice guideline (E6 R3) and enters into force on December 1, 2025.
• The scope is limited to Phase I–III trials and registrational protocol variations, while excluding bioequivalence, biodisponibility and non‑interventional research.
• ANMAT’s clinical research directorate gains explicit powers to authorize, supervise and sanction studies, maintain a public registry, and interview participants when health risks are identified.
• Authorities cite goals to decentralize and speed authorizations, attract investment and research activity, and expand patient protections, with industry data noting 1,000+ ongoing trials involving over 50,000 participants.