On September 2, 2026, the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), published in the Official Gazette of the Federation the “Agreement Issuing the General Guidelines for the Application of the Abbreviated Regulatory Pathway for Granting Marketing Authorizations for Medicines” (the “Agreement”), pursuant to which the requirements, tests, and evaluation procedures conducted by the National Health Surveillance Agency of the Federative Republic of Brazil (“ANVISA”) are recognized as equivalent for purposes of the authorization process in Mexico.
The Agreement introduces a reliance mechanism — a well-established instrument in international regulatory practice by which a competent authority takes into account, and builds upon, the scientific and technical evaluation conducted by a reference authority, without duplicating the underlying assessment. Critically, however, this does not operate as automatic recognition or mutual recognition: COFEPRIS retains full discretionary authority over the final marketing authorization decision, and applicants remain required to submit the complete legal, technical, and scientific dossier necessary for COFEPRIS to reach its own determination.
For laboratories and pharmaceutical companies holding ANVISA-approved medicines, the Agreement opens a meaningful new avenue for obtaining Mexican marketing authorization through an expedited procedure. Nonetheless, the Agreement sets forth important limitations: COFEPRIS may not apply the abbreviated pathway where ANVISA’s underlying evaluation was conducted on an emergency basis, pursuant to a court order, or through another reliance mechanism, among other enumerated exceptions.
While Mexico has had a general abbreviated regulatory pathway framework in place since 2025, the Agreement establishes, for the first time, a jurisdiction-specific framework for leveraging ANVISA’s regulatory decisions in respect of medicines — advancing a model of international regulatory reliance that seeks to eliminate duplicative assessments, optimize regulatory resources, and accelerate patient access to medicines.
For further information on the implications of this development for your regulatory strategy in Mexico, or for advice on authorization proceedings before COFEPRIS, please contact our Life Sciences & Healthcare Regulatory practice. We remain available to advise on the full scope of the Agreement’s application and its impact across pharmaceutical supply chains and market-access strategies in Mexico.
If required any further information regarding the content of this Alert, please contact:
Mariana Larrea | Partner: mlarrea@pcga.mx
