Special Section: Latin America
Fostering Regulatory Convergence:
US FDA’s Regulatory Impact and Engagement in Latin America
Michelle Rodriguez
Vesa Vuniqi
FDA Latin America Office

023 marks the 15th anniversary of the opening of the US FDA’s first foreign office, in Beijing, China. FDA currently maintains offices in Brussels, Belgium (Europe Office); in New Delhi, India (India Office); and in three cities in Latin America that comprise the Latin America Office: San Jose, Costa Rica; Mexico City, Mexico; and Santiago, Chile. FDA opened these offices in response to a series of public health tragedies in which Americans were sickened or killed by poor quality or adulterated imported products, such as diverted and counterfeit glucose monitor test strips, adulterated heparin, and cantaloupes contaminated with salmonella.

This article explains the history and mandate of the US FDA’s Latin America Office to provide a better understanding of how this office has been collaborating to promote stronger and more resilient regulatory systems across the region.

The Latin America Office (LAO), which opened in early 2009, follows a different model than FDA offices in China and India. LAO functions as the lead for the FDA’s on-site presence in the 44 countries and territories that span Latin America, from the US-Mexico border to the tip of South America, Central America, the Caribbean, and Mexico. Our headquarters is in San Jose, Costa Rica.

These foreign offices fulfill a critical role: They function as FDA’s eyes and ears in the country or region where they are located. Our staff closely follow regulatory and market developments, accumulating vital local expertise over time. These professionals identify trends in manufacturing and product safety and quality and meet with pertinent representatives of industry and government, educating them about FDA’s regulatory requirements and building relationships that wouldn’t be possible by engaging from afar. FDA staff also conduct inspections of manufacturing facilities in their host countries.

Achieving internationally aligned medical product regulations, standards, guidelines, and requirements across the Western Hemisphere is among the most important ongoing projects for our medical products team in Latin America.

FDA, our regulatory counterparts, and the industry we regulate all exist in an interconnected world. Many of the products we regulate follow complex global supply chains; when a medical product shortage or a safety problem arises in one country, it may cause a ripple effect around the globe. Any single regulatory authority may lack the resources and the global scope to address some of these challenging issues, but we can better protect and promote public health by working together.

This was one of the most important lessons from the COVID-19 pandemic. Early alignment on best practices, coupled with information-sharing and collaboration among regulators and manufacturers, facilitated the speedy market authorizations of novel or repurposed COVID-19 medicines, diagnostics, and vaccines, and paved the way for providing these critical medical countermeasures to healthcare providers and the public.

2023 marks a crucial moment in the search for regulatory harmonization and convergence for the medical products industry in Latin America. Industry in this region is flourishing, producing a wide range of products from low-risk to high-risk (such as heart valves). Unpublished internal FDA analysis indicates that Latin America accounts for 23% of the medical devices imported into the United States, with Mexico leading the way. But how medical products are regulated across Latin America varies greatly. Some countries already have mature regulatory systems and actively participate in global regulatory harmonization and convergence efforts. In others, regulatory systems are just being established.

This creates an ideal opportunity for engagement on this topic. One example is promoting the importance of adopting Good Regulatory Practices (GRP). GRP principles embody the belief that regulations and regulatory frameworks that are modern, transparent, predictable, and rooted in a thorough understanding of science and risk analysis best position us to protect and promote public health. Adherence to GRPs ensures that regulatory outcomes reflect a consultation process that includes relevant government departments and agencies, relies on high-quality scientific data and information, and accounts for stakeholder and public comments.

Opportunities for, and outcomes of, international regulatory cooperation are strengthened when regulatory agencies have common objectives or priorities and have common or similar regulatory frameworks, meaning that they rely on similar scientific analysis or data elements when making regulatory decisions.

The FDA LAO is actively encouraging the embrace of GRP across the region. In June 2023, the office hosted a webinar focused on the implementation of GRPs for the oversight of pharmaceutical products in collaboration with the Latin American Federation of the Pharmaceutical Industry (FIFARMA) and the Brazilian Health Regulatory Agency (ANVISA). More than 450 people representing 14 regulatory agencies across Latin America and the Caribbean, and industry from 29 countries, participated in this event.

Beyond general support for GRPs, the LAO works to support regulatory convergence and harmonization across several fronts: bilaterally, regionally, and multilaterally, in standards-setting and in our work on quality systems.

Bilaterally, we share information about decision making, sometimes through agreements governing the exchange of confidential information. During the pandemic, we had continuous bilateral exchanges with regulatory authorities in Argentina, Brazil, Colombia, Chile, and Mexico to understand events in their country and to share what was happening in ours. By sharing information on FDA regulatory product review and decisions, FDA supports regulatory convergence and reliance mechanisms.

We promote alignment and engagement on a regional basis by organizing educational workshops, participating in outreach opportunities, collaborating with various stakeholders, and through our participation in the Pan American Health Organization’s medical device working group and eight National Regulatory Authorities of Regional Reference (ANMAT of Argentina, ANVISA of Brazil, CECMED of Cuba, COFEPRIS of Mexico, Health Canada, ISP of Chile, INVIMA of Colombia, and US FDA). Together, these eight authorities are responsible for 82% of the population of the Americas. Other regional webinars organized by FDA LAO reached more than 4,500 participants (regulators and industry) and focused on strategic topics to align regulation for product authorization and inspections, such as the Medical Device Single Audit Program (MDSAP), ISO13485: Quality Management Systems Manufacturing Standards for medical devices, Unique Device Identification (UDI) requirements, development and implementation of consensus standards for medical devices, software as a medical device (SaMD) regulatory requirements, medical device shelf-life, cybersecurity in healthcare, generic drug regulation, bioequivalence studies, and GRPs.

The International Medical Device Regulators Forum (IMDRF) established in 2012 is the primary vehicle for accelerating global medical device convergence and harmonization; the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), established in 1990, is the equivalent for pharmaceutical products. FDA, a member from the start, has actively supported and encouraged our regulatory counterparts in Latin America to participate in these organizations. Brazil is already a member of IMDRF and ICH, Argentina is an ICH observer and achieved IMDRF observer status in 2021, and Mexico is already a member of ICH and seeking similar IMDRF observer status.

Whether working bilaterally, regionally, or multilaterally, the FDA LAO is committed to helping strengthen the region’s regulatory systems and to addressing needs that advance the agency’s international objectives and in turn contribute to improvements in global public health.