Brazil’s National Health Surveillance Agency (ANVISA) and Paraguay’s National Directorate of Health Surveillance (DINAVISA) signed a new Memorandum of Understanding (MoU) on 20 August 2026, expanding a previous cooperation agreement signed in 2024.
Scope of the agreement
The MoU focuses on strengthening joint inspection and health control activities, with a primary emphasis on preventing and combating counterfeiting and the irregular circulation of products under sanitary surveillance. The agreement covers the exchange of information on the manufacture and distribution of pharmaceutical inputs, medicines, cosmetics, and tobacco products.
A key driver behind the enhanced cooperation is the sharp increase in the smuggling of weight-loss pens—particularly semaglutide and tirzepatide—from Paraguay into Brazil. Paraguayan health authorities have stated that products registered in Paraguay comply with sanitary requirements, but the cross-border trade has raised significant regulatory concerns.
Regulatory reliance and convergence
Both agencies explicitly framed the MoU within the context of regulatory reliance. Jorge Iliou Silvero, Interim National Director of DINAVISA, stated that the partnership enhances ‘regulatory reliance, convergence, and the adoption of good regulatory practices’. ANVISA CEO Leandro Safatle noted that ‘regulatory alignment among countries in the region is a crucial step toward enhancing inspection efforts’.
This development follows a broader trend of regulatory integration in Latin America. In February 2026, ANVISA and Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) signed a similar MoU establishing mutual recognition and reliance frameworks for medicines, medical devices, and GMP certification [1]. Such agreements allow agencies to leverage each other’s assessments, reducing duplication and accelerating market access.
Implications for biosimilar markets
While the ANVISA–DINAVISA MoU does not directly address biosimilars, it has indirect implications for the sector. Enhanced regulatory cooperation between the two countries could lay groundwork for future convergence on biological product evaluation, particularly as Paraguay continues to develop its biosimilars framework. DINAVISA has established guidelines for biosimilar evaluation based on WHO technical reports and has approved biosimilar monoclonal antibodies for oncology and autoimmune indications [2].
Brazil remains the dominant biosimilars market in the region, with 67 active biosimilar registrations and over 90 products approved as of September 2025 [3]. The country is expected to set a record for new biosimilar approvals in 2026. As regulatory reliance mechanisms expand across Latin America, harmonised approaches to biosimilar oversight could facilitate broader market access and reduce costs across the region.
Related articles
ANVISA updates understanding on biosimilar interchangeability. 22 July 2026
The biosimilars market in Latin America: a summary
References
1. GaBI Online - Generics and Biosimilars Initiative. Brazil and Mexico forge alliance to streamline medical approvals and boost production [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/policies-legislation/brazil-and-mexico-forge-alliance-to-streamline-medical-approvals-and-boost-production
2. GaBI Online. Biosimilars approved in Paraguay. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 15]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-paraguay
3. Cestari de Oliveira SH, Wassermann GE. Follow-on biologicals/biosimilars approved in Brazil: September 2025 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(2).47-52. doi:10.5639/gabij.2025.1402.008
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