ANMAT – Disposition No. 7516/2025
Healthcare & Life Sciences Department Report | ANMAT – Disposition No. 7516/2025.
Dear All:
On October 9, 2025, Disposition No. 7516/2025 (the “Disposition”) was published in the Official Gazette. Through this measure, the National Administration of Drugs, Food and Medical Technology (“ANMAT”) updates, unifies, and strengthens the regulatory framework applicable to Good Clinical Practices (GCP) for clinical pharmacology studies for registration purposes in Argentina. The new rule formally adopts the ICH E6 (R3) guideline, repeals the prior regime (ANMAT Disposition No. 6677/2010 and its amendments), and approves a comprehensive set of annexes regulating authorization, execution, oversight, and inspection of studies, thereby aligning national standards with best international practices and reinforcing participant protection and data reliability.
Below we highlight the most significant elements introduced by the Disposition:
1-Object and Scope: The Disposition approves GCP standards and oversight for clinical pharmacology studies for registration purposes (phases I, II and III, and variations). It excludes bioequivalence/bioavailability studies, non‑interventional studies, and studies not intended for registration. Sponsors must seek ANMAT authorization before initiating studies covered by this regulation.
2-Adoption of ICH E6 (R3) and Glossary: The ICH E6 (R3) guideline is adopted as the reference standard for the design, conduct, supervision, and reporting of trials, complemented by local requirements (Annex I). A standard glossary (Annex VI) is also approved to ensure technical and regulatory consistency.
3-Material Scope and Legal Integration: The Disposition is integrated with the National Civil and Commercial Code (sections 58 and 59), Law 26.529 (patients’ rights law), and Resolution MS 1480/11 (human research guideline), particularly in matters of ethics and informed consent. It clarifies ANMAT’s competence to authorize protocols and oversee execution under conditions approved by accredited Ethics Committees.
4-Functions of the Competent Direction: The Clinical Research and Drug Registration Directorate evaluates and issues recommendations on protocols, authorizes researchers and centers, supervises regulatory compliance via inspections and report analysis, manages the study database, intervenes in material imports, and can suspend studies for noncompliance. It also fosters best practices, liaises with ethics committees, and proposes process improvements, particularly in health emergency contexts.
5-Local GCP Requirements: Annex II supplements ICH E6 (R3) by detailing local GCP requirements for registration‑purpose pharmacology studies regarding Institutional Review Committees/Ethics Committees (IRB/EC), Investigators, and Sponsors. It covers minimum ethical review documentation, accreditation of IRB/ECs, team competence, labeling and handling of investigational product in Spanish, record retention for 10 years, periodic and final reporting, insurance/indemnification, data protection (Law 25.326), and Appendix D on informed consent requirements (including consent by representation).
6-Authorization Procedure, Timelines & Prioritization: Annex III establishes differentiated evaluation pathways with expedited timeframes for low‑risk or prioritized studies (neglected infectious diseases, orphan drugs, seasonal/emergency), mandatory pre‑meetings for phase I, advanced therapies, and innovation, and abbreviated processes during emergencies, without compromising safety. It also delineates when ANMAT authorization or mere notification is required and defines requirements and deadlines for adding or removing investigators/centers, emphasizing experience and infrastructure.
7-GCP Inspections and Regulatory Outcomes: Annex IV formalizes inspection procedures (routine or for cause), their preparation, conduct, and documentation, including participant interviews and document copying. Outcomes may range from no action to corrective measures, suspensions, data rejection, or administrative/legal sanctions.
8-First‑in‑Human Studies & Phase I Centers: Annex V sets infrastructure, emergency equipment, standard operating procedures (SOPs), personnel, and protocol requirements for phase I studies, with ANMAT inspections to authorize “first-in-human” centers. Authorizations are issued by Disposition and must be kept current upon significant changes.
9-Repeals and Transitional Regime: ANMAT Dispositions Nos. 6677/10, 4008/17, 9929/19, and 2172/25, as well as related circulars, are expressly repealed, consolidating the new regulatory framework.
This Disposition will come into force on December 1, 2025. Any ongoing procedures pending at the time of its entry into force will be reviewed and resolved under the previous regime until their completion.
Sincerely,