n August 2025, during an official mission of the Brazilian government to Mexico, representatives of the Brazilian regulatory authority ANVISA signed a new Memorandum of Understanding (MOU) with the Mexican Agency COFEPRIS. A MOU is a formal, nonbinding agreement that details the mutual goals, responsibilities, and intentions of two or more parties, as a framework for collaboration. In this interview, Ana Carolina Marino, head of the International Relations Office of ANVISA, provides more details on this bilateral agreement.

ANVISA and COFEPRIS maintain a historical relationship of cooperation and technical dialogue, which reflects a shared commitment to strengthening regulatory systems in Latin America. For example, under a previous MOU, both agencies shared information such as inspection results and marketing authorizations of medical products. Furthermore, the Brazilian and Mexican authorities also have a long history of sharing best practices and participating in training initiatives as part of a collaboration within the Regional National Regulatory Reference Authorities (NRAr) meetings, organized by the Pan American Health Organization (PAHO). This partnership has been consolidated over the years through exchanges of regulatory information, joint training sessions, and, especially, through constant participation in international regulatory convergence forums, such as the International Council for Harmonisation (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the International Coalition of Medicines Regulatory Authorities (ICMRA). This continuous interaction allows for the identification of shared challenges and collaboration opportunities on topics such as good manufacturing practices, drug evaluation, and institutional strengthening.

The signing of the new cooperation instrument between the two agencies represents the renewal of this commitment, now guided by a more strategic vision and aligned with international practices of regulatory reliance. The document reflects the maturation of relations between Brazil and Mexico in the field of health product regulation and seeks to expand technical exchange.

At the time of the signing, ANVISA and COFEPRIS highlighted that they recognize each other as reference authorities for the purposes of reliance in different regulatory functions, such as registration and inspections. Can you elaborate more on this topic? Is there already, or is there a plan for, a mutual recognition mechanism between the agencies?

A formal mechanism for mutual recognition between the two agencies does not yet exist; however, both already incorporate the use of reliance in their regulatory routines, especially in the areas of registration and inspection of medicines and medical devices.

In the case of ANVISA, Normative Instruction 292/2022 establishes the basis for the use of information from authorities considered to be a reference—among them, members of PIC/S and ICH, a group to which both COFEPRIS and ANVISA belong. This means that reports and certifications issued by the Mexican authority may be considered by ANVISA in the decision-making process, when relevant.

For its part, COFEPRIS recently progressed by publishing, in July 2025, the Lineamientos Generales para la Aplicación de la Vía Regulatoria Abreviada (General Guidelines for the Application of the Abbreviated Regulatory Route), which recognize the health product registration and the certificates of Good Manufacturing Practices for medical devices issued by ANVISA. Previously, in March 2025, Lineamientos (Guidelines) were published that provide for the recognition of Good Manufacturing Practices Certificates for medicines issued by ANVISA.

The MOUs and Agreements have as their main objective the establishment of formal bases for the exchange of technical information, providing for the exchange of confidential data and documents, as well as the designation of contact points that facilitate communication between the authorities.

It is important to note, however, that the existence of a formal agreement is not a necessary condition for a foreign authority to adopt reliance on ANVISA’s decisions, and this trust can occur unilaterally, based on the recognition of the robustness and credibility of the Brazilian regulatory system.

Likewise, for ANVISA, the existence of a MOU or Confidentiality Agreement is not a mandatory requirement for the recognition of an Equivalent Foreign Regulatory Authority (AREE), although these instruments contribute to strengthening cooperation and to the effective operationalization of reliance practices.

ANVISA and COFEPRIS regulate the largest Latin American markets for products subject to health product surveillance, with complex industrial parks, numerous populations, and government participation in the provision of health products and services. How do the topics of this agreement relate to the discussions about the expansion of local manufacturing of health products in both countries?

In general, the stronger and more reliable the regulatory agency, the more robust and competitive the industry that it supervises becomes. Thus, the strengthening of ANVISA and COFEPRIS not only guarantees the protection of the population’s health but also stimulates industrial and technological development, promoting a virtuous cycle of quality, innovation, and availability of health products in both countries.

The MOU opens possibilities for regulatory alignment and collaboration between ANVISA and COFEPRIS. Is there any initiative or prospect of regulatory harmonization between Brazil and Mexico in the area of health product surveillance? And is there a provision for shared work—for example, joint evaluation of registration applications—between the two agencies, or even regionally?

The MOU between ANVISA and COFEPRIS opens opportunities for alignment and technical cooperation between the two agencies. However, ANVISA prioritizes regulatory harmonization within the multilateral scope, operating in international forums such as ICH and PIC/S, adopting globally recognized standards. This approach avoids rework and misalignment that could occur in bilateral or regional initiatives.

Finally, is there any topic not yet covered that you believe is relevant to our readers?

ANVISA does not currently have formal agreements for the mutual recognition of registrations or inspections of medicines. However, the agency has made consistent progress in implementing reliance practices, consolidating itself as a reference regulatory authority in the region.

At the same time, ANVISA is committed to supporting other regulatory authorities in reducing regulatory asymmetries, promoting greater consistency and quality in the evaluation processes of products subject to health product surveillance.

The agency strongly encourages the participation of Latin American authorities in multilateral forums for convergence and harmonization, adopting recognized international standards and promoting global regulatory alignment.

In this context, Memoranda of Understanding play a strategic role, as they establish formal channels for the exchange of technical and confidential information, strengthening cooperation and promoting better regulatory practices.