n the dynamic landscape of global regulatory practices, Latin America (LATAM, including the Caribbean) is embarking on transformative initiatives to strengthen its international standing as a large global region and align with the World Health Organization’s (WHO) Global Benchmarking Tools (GBT) for evaluation of national regulatory systems.

The findings and recommendations from the 2024 DIA Latin America Annual Meeting held in Brasilia (Brazil) in September 2024 focus on the best regulatory practices for regional cooperation in Latin America, discuss the importance of implementing reliance, and address the challenges of global harmonization in this region. This high-level roadmap for future advances in regulatory and health systems across the region explores the current challenges and opportunities, based on insights shared by regulatory and scientific experts who represented multiple sectors during the meeting, including pharmaceutical and biotechnology industry, global regulatory authorities, nonprofit organizations and scientific associations like DIA, and academic institutions from 15 different countries in the region, plus representatives from the US, Europe, and South Africa.

Strengthening Regulatory and Clinical Systems for Global Impact

In Brazil, ANVISA’s strategic plan for 2024-2027 focuses on fostering regulatory convergence and enhancing reliance frameworks, facilitating collaboration among agencies of comparable maturity. This vision reinforces the region’s commitment to addressing global health challenges, such as pandemics and climate-related health crises, through enhanced trust-building measures like WHO benchmarking and prequalification programs. (On January 20, 2025, the US pulled out of WHO, and the impact of this withdrawal will most likely affect ongoing efforts for collaboration across the Americas.)

Achieving maturity level recognition by WHO demands rigorous self-assessment and proactive participation in global regulatory networks. Experiences from the LATAM region highlight the necessity of early alignment with WHO indicators and the consistent updating of Quality Management Systems (QMS) to ensure sustained improvement. This approach not only strengthens internal processes but also positions agencies as reliable partners in the global health ecosystem.

Advancing regulatory practices across LATAM requires a concerted effort among multiple stakeholders to bridge the gap between Good Regulatory Practices (GRPs) and their implementation. Key obstacles include the limited integration of GRPs, the insufficient use of reliance mechanisms throughout products’ lifecycles, the lack of regulatory tools to prioritize or expedite the assessment and registration of treatments benefiting patients with rare diseases or unmet medical needs, and limited resources. Regulators are prioritizing regulatory convergence, reliance-based approaches, and streamlined product testing processes in efforts to safeguard quality and safety while ensuring uninterrupted supply chains. These efforts are critical for achieving a resilient and adaptive regulatory environment in the region.

Today, Latin American regulators are advancing cooperation schemes to harmonize global standards and drive innovation faster. By embracing these opportunities, the region seeks to enhance healthcare access and outcomes, reinforcing its role as a vital contributor to global health regulation.

Enhancing Safety and Pharmacovigilance Practices

LATAM’s landscape for safety and pharmacovigilance is dynamic and evolving, as regulatory advancements, technological innovation, and collaborative efforts are currently driving impactful progress in the region. However, the region faces unique challenges, including diverse regulatory frameworks, multiple languages spoken across borders, varying levels of regulatory harmonization, and the need for robust systems to manage the safety of pharmaceutical products and medical devices. At the same time, this environment offers valuable opportunities to implement global best practices tailored to regional contexts, enhance patient safety, and foster reliance and collaboration among stakeholders.

Harmonization of Pharmacovigilance and Technovigilance

One of the critical areas of focus in Latin America is the harmonization of pharmacovigilance and technovigilance (medical device surveillance) practices. Efforts to align regional regulatory systems with international frameworks, such as those established by the International Council for Harmonisation (ICH) and the International Medical Device Regulators Forum (IMDRF), aim to standardize safety reporting, risk management, and data exchange processes. These initiatives not only streamline regulatory activities but also enhance the overall safety monitoring infrastructure by fostering trust and collaboration across borders.

For example, ANVISA in Brazil utilizes systems such as Notivisa and e-Notivisa for adverse event reporting for medical devices and VigiMed for engaging healthcare professionals, the public, drug registration holders, and study sponsors on suspected adverse events related to drugs and vaccines. In Mexico, COFEPRIS has adopted WHO drug standards and global pharmacovigilance guidelines while collaborating with the Danish Medicines Agency to strengthen signal management and risk plans. Similarly, DIGEMID in Peru has a long-standing history in pharmacovigilance and technovigilance, integrating VigiFlow for COVID-19 vaccine safety monitoring and developing technical standards and manuals for enhanced vigilance. Regional organizations like MERCOSUR and PAHO further support harmonization by creating guidelines for post-market surveillance and fostering cross-regional collaboration through forums like the International Medical Device Safety Meeting (IMDS) and the Regional Working Group of Medical Device Regulators. Together, these initiatives are working to address challenges posed by diverse regulatory frameworks, paving the way for improved patient safety, robust monitoring systems, and sustained progress in LATAM’s pharmacovigilance and technovigilance.

Pharmacovigilance Inspections

Regulatory authorities in the region increasingly emphasize the need for robust pharmacovigilance systems within the regulated sector. Understanding current trends, common concerns, and lessons learned from inspections can help organizations align their practices with regulatory expectations and identify areas for improvement, ultimately enhancing compliance and safety outcomes. According to presentations at this event:

• From August 2022 to August 2024, DIGEMID performed 99 GPP certification inspections and certified 82 marketing authorization holders. From January to August 2024, DIGEMID carried out 38 inspections under good pharmacovigilance practices (GPP). DIGEMID also plans to reduce inspections to two business days to further optimize their resources.
• ANVISA performed 10 inspections in 2024 for both national and importing companies, and discovered the need to update certain procedures, conduct more self-inspections and training, and improve noncompliant signal detection and scientific literature search processes.
• The Costa Rican Drug Institute is also currently updating procedures, guidelines, and regulations, and performed 26 inspections and one reinspection of companies and/or laboratories in 2024.

Risk Management and Communication

Additionally, effective risk management and communication are critical to safety strategies in the region. From the development of risk management plans (RMPs) to the implementation of risk minimization measures (RMMs), the ability to identify, communicate, and mitigate risks is essential for maintaining public trust and safeguarding patient well-being. Tailoring these approaches to the specific challenges and opportunities in Latin America is crucial for achieving meaningful and sustainable outcomes.

Insights from Brazil and the European Union shared at this event further highlight best practices in risk management and communication. In Brazil, education on the appropriate use of drugs, the interpretation of safety information, and the open availability of evidence to assess risks and benefits are crucial components of RMPs and RMMs. Safety reporting in the post-authorization phase is as important as during clinical trials, underscoring the need for ethical and effective communication. In the European Union, emerging trends include the use of RMPs for generic medicines and advancements in pregnancy-specific RMMs, supported by mixed-methods research and multidisciplinary approaches. These efforts emphasize the importance of international collaboration, trust-building, and patient-centered care in improving risk management processes, ensuring that safety strategies are adaptable and responsive to evolving healthcare needs.

Patient Safety and Centricity

Patient empowerment and engagement have also emerged as central themes in safety in LATAM. Efforts to enhance health literacy, combat dis- and misinformation, and involve patients in decision-making processes reflect a growing recognition of the importance of patient-centric approaches in achieving better healthcare outcomes in the region. Initiatives such as eLabeling and clear communication strategies are critical tools for enabling patients to take an active role in their healthcare journey. A patient-centered approach requires addressing systemic barriers and prioritizing the patient perspective. Challenges such as insufficient preparation, limited availability, and underrepresentation of patients often hinder effective engagement. Developing policies that address social determinants of health and adopting regulatory updates to align with evolving patient expectations can break down barriers to participation. Transparency and trust between the pharmaceutical industry, regulatory authorities, and patients are critical, as greater engagement leads to improved healthcare decisions and outcomes. These advancements in patient safety and centricity underscore the need for a collaborative and inclusive ecosystem that places patient voices at the forefront across the LATAM region.

Advancing Medical Affairs and Scientific Communication

Across the globe, Medical Affairs and Scientific Communication are becoming strategic pillars in healthcare, bridging complex scientific data with actionable insights for diverse stakeholders, including healthcare professionals (HCPs) and non-HCPs. This evolution reflects the growing demand for transparency, innovation, and collaboration in healthcare. By adopting integrated and targeted communication strategies, Medical Affairs ensures that critical information is accessible and impactful, fostering seamless data sharing and strengthening collaboration to advance healthcare delivery.

The rise of artificial intelligence (AI) is another significant development in all the geographic regions of the world. Today, AI is transforming how the field of Medical Affairs operates, offering powerful tools to analyze and disseminate data more efficiently. However, the responsible use of AI remains a critical focus, and experts at the DIA meeting stressed the importance of educating HCPs on AI’s potential while addressing concerns about bias and reliability to maintain trust in these emerging technologies. In addition, patient-centricity remains a fundamental pillar of Medical Affairs strategies. Prioritizing partnerships and incorporating a patient-focused approach into scientific communications are essential to fulfilling Medical Affairs’ commitment to the meaningful and impactful translation of scientific innovation that truly addresses patient needs. These efforts not only foster trust but also play a significant role in enhancing healthcare outcomes.

Furthermore, leveraging medical information to strengthen Medical Affairs strategies is increasingly recognized in the LATAM region. Therefore, there is a growing demand for medical information services that draw insights from a global context while also addressing region-specific needs, such as understanding essential customer motivations, in order to deliver meaningful information.

The adoption of digital health technologies and tools (DHTs) and AI platforms is transforming the delivery of scientific communication, enhancing both its reach and efficiency. These unprecedented improvements are creating new opportunities for engaging diverse audiences and enhancing the effectiveness of communication strategies while empowering life science companies. Medical Affairs professionals must embrace these technological and strategic advances as the LATAM health system landscape evolves to meet the growing demands of stakeholders while maintaining accurate data and remaining a reliable information source and resource. Their efforts will ensure effective communication, further healthcare innovation, and reinforce their pivotal role in improving patient outcomes.

Conclusion and Invitation

Throughout 2024, global themes such as the need for more cooperation and partnerships, as well as for better frameworks for implementing AI and similar innovations, were important building blocks in the foundations of innovative medical product development and regulation in the LATAM region.

The 2025 DIA Latin America Annual Meeting is currently being planned for Buenos Aires, Argentina, in late September or early October 2025. It will continue to explore the above issues and other lessons learned from the application of good regulatory practices across LATAM to encourage regional cooperation and reliance and overcome the challenges and opportunities of global harmonization.

Learn more about this topic in the regional sessions at DIA’s 2025 Global Annual Meeting.

DIA Latin America Annual Meeting 2024 opening plenary session.