Overview
In a strategic move to strengthen public health in Latin America, Brazil and Mexico are advancing negotiations to sign important bilateral agreements. Preliminary discussions, which took place in August, involved a Brazilian delegation led by Vice President Geraldo Alckmin and the Mexican government, led by President Claudia Sheinbaum. The main focus of these agreements is cooperation in key areas such as vaccines, medicines, and regulatory harmonization. The final agreements are expected to be signed in 2026.
Introduction
The meetings resulted in two distinct memorandums of understanding, which signal a new chapter in collaboration between the region’s two largest economies.
The first memorandum, signed between Brazil’s Health Surveillance Agency (ANVISA) and Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS), aims to increase mutual regulatory reliance. This initiative is a crucial step to accelerate product approvals, facilitate clinical research, and allow for joint or reciprocal certification of pharmaceutical production plants. This not only optimizes processes but can also benefit the pharmaceutical industry in other countries, provided they align with the established criteria.
The second memorandum of understanding, between Brazil’s Oswaldo Cruz Foundation (FIOCRUZ) and Mexico’s Biological and Reagent Laboratories (BIRMEX), focuses on the production of vaccines and active pharmaceutical ingredients. Both institutions are state-owned and play vital roles in their respective public health systems. The agreement prioritizes the production of vaccines against dengue and other arboviruses, as well as coagulation factors, albumin, and immunoglobulins. To ensure timely progress on these initiatives, a bilateral health committee was created that will meet monthly.
These agreements reflect a shared vision that health is a fundamental right and that scientific and technological development, coupled with local production, are essential to strengthen the countries’ health sovereignty.
Regulatory Affairs
Key Points of the Agreement
To help you quickly understand the relevance of these agreements, we’ve highlighted the most important points that will impact the health and regulatory sectors:
Faster Approvals: The memorandum between ANVISA and COFEPRIS aims to increase mutual regulatory reliance, which can significantly speed up product approval processes.
Collaborative Production: The agreement between FIOCRUZ and BIRMEX will focus on the joint production of vaccines against dengue and other arboviruses, in addition to essential medicines.
Reciprocal Certification: One of the most promising initiatives is the possibility of joint certification of pharmaceutical production plants, including those located in other countries.
Strengthening Health Sovereignty: The cooperation aims to reduce reliance on external inputs, strengthening both countries’ ability to produce what is necessary for the health of their populations.
Continuous Monitoring: The creation of a health committee with monthly meetings demonstrates both governments’ commitment to ensuring the progress and success of the initiatives.
Conclusion
The preliminary agreements between Brazil and Mexico represent an important milestone for public health in Latin America. By promoting regulatory cooperation and the joint production of essential inputs, the countries are not only optimizing processes but also ensuring greater autonomy and capacity to respond to future health challenges. The collaboration between ANVISA and COFEPRIS, as well as between FIOCRUZ and BIRMEX, demonstrates a commitment to the well-being of their populations, reinforcing the leadership position of both countries in the region.
The ever-changing regulatory landscape, as illustrated by these agreements, requires constant expertise and updates. GRP has qualified specialists to assist clients with regulatory matters in Brazil and Mexico, ensuring compliance and efficiency. If your company is looking to navigate these complexities, GRP can be your ideal partner.
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References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.