Brazil and Mexico have forged a dual regulatory and production alliance to streamline medical product approvals and boost regional manufacturing capacity for critical health technologies.
In a significant move to strengthen Latin America's health sovereignty, the regulatory authorities of Brazil and Mexico have signed a new Memorandum of Understanding (MoU). The agreement between Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) and Mexico's Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) establishes a framework for mutual recognition and reliance on approvals for medicines, medical devices, and Good Manufacturing Practices (GMP).
Under the terms of the MoU, Mexico has designated ANVISA as a ‘Reference Regulatory Authority’, which will expedite registration of medical devices and GMP certification of medicines and devices. Conversely, Brazil has recognised COFEPRIS as an ‘Equivalent Foreign Regulatory Authority’ for GMP certification of medicines. This mutual reliance allows each agency to leverage the other's regulatory assessments, reducing duplication and accelerating market access for innovative products.
This initiative reflects a broader global trend in regulatory cooperation, where reliance and recognition mechanisms are increasingly adopted to optimise limited resources and strengthen public health systems[1].
Alongside the regulatory agreement, a second MoU was signed between Laboratorios de Biológicos y Reactivos de México (Birmex) and Fundação Oswaldo Cruz (Fiocruz). This collaboration focuses on the joint local production of vaccines, active pharmaceutical ingredients, immunoglobulins, coagulation factors, and treatments for diseases like dengue, including cooperative work on messenger RNA (mRNA) vaccine technology.
A trend toward regional integration
Announced in late August 2025, these dual initiatives represent a strategic two-pronged approach: streamlining regulations while boosting regional manufacturing capacity. This strategy enhances regional self-sufficiency and reduces dependence on external supply chains. It also aims to strengthen local production capacity and ensure faster distribution of critical health technologies across Latin America. This is particularly critical for a bilateral trade in pharmaceuticals and medical devices that already exceeds one billion US dollars.
Industry observers note that these actions reflect a growing regional trend toward regulatory reliance frameworks [1]. By harmonising standards and sharing expertise, both countries can accelerate access to new therapies, lower oversight costs, and improve coordination in inspections and post-market surveillance. This approach also aligns with recent developments in Brazil, where authorities opened a public consultation to modify the country’s biosimilars regulation—an example of ongoing regulatory modernization efforts [2].
The success of these agreements will hinge on effective implementation. Both governments are expected to establish joint committees, align technical standards, and facilitate real-time data sharing. Mexican authorities have already committed to regular bilateral meetings to ensure the cooperation yields tangible results.
Through this combination of regulatory trust and industrial collaboration, Mexico and Brazil are positioning themselves as leaders in shaping a more integrated, efficient, and resilient health ecosystem for Latin America.
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References
1. Sachdeva V. A review of international initiatives on pharmaceutical regulatory reliance and recognition. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(3):151-9. DOI:10.5639/gabij.2024.1303.034
2. GaBI Online - Generics and Biosimilars Initiative. Public consultation for the modification of the biosimilars regulation in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Feb 9]. Available from: www.gabionline.net/policies-legislation/public-consultation-for-the-modification-of-the-biosimilars-regulation-in-brazil
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