cross Latin America, the life sciences ecosystem is undergoing a decisive transformation marked by regulatory modernization, the embrace of innovative clinical research models, and a renewed commitment to patient-centered safety frameworks. In the wake of a long history of fragmentation, the region now faces unprecedented opportunities for collaboration, synergy, and progress along with significant operational challenges that it is preparing to meet.

This article distills the most impactful insights from the DIA Latin America Annual Meeting 2025, including regulatory reliance, good regulatory practices, regulatory harmonization through ICH, advanced therapies, real-world evidence, pharmacovigilance modernization, and patient engagement. These insights reflect the region’s collective movement toward more agile, connected, high-performing regulatory systems to elevate the region’s global role in drug development, expand timely patient access to innovative therapies, and pharmacovigilance.

Regulatory Convergence and Reliance: A New Regional Baseline

Latin American authorities are increasingly shifting toward internationally aligned, process-predictable, efficiency-driven regulatory systems. This momentum is particularly evident in the implementation of regulatory reliance, now recognized as an essential strategy for managing workloads, improving review quality, and accelerating access to high-value therapies. For Latin American regulators, strengthening reliance mechanisms not only improves operational efficiency but also aligns their systems with international standards, paving the way for WHO Listed Authority (WLA) designation and broader participation in global health initiatives. (Further perspectives on how collaboration and reliance are being translated from theory into practice are available in this DIA Latin America Annual Meeting pre-conference workshop summary report.)

Across the region:

• Argentina’s ANMAT is finalizing a structured reliance mechanism for marketing authorization reviews and integrating ICH, CTD, and PIC/S standards, alongside streamlined processes for imports and clinical trials.
• Chile’s ISP successfully piloted a reliance-based backlog reduction process, granting authorizations and identifying pathways to institutionalize reliance.
• Ecuador’s ARCSA applies reliance pathways for biological products with consistently fast review timelines (around 45 days for a review).
• El Salvador and Brazil are embedding reliance principles within broader modernization frameworks that include digitalization and standardized quality systems.

This convergence reflects a shared belief: Reliance is not a shortcut; it is a scientifically sound strategy that enhances rigor, transparency, and predictability. Reliance works best when supported by robust quality systems, clear governance, and continuous training. Brazil’s progress toward WLA recognition and El Salvador’s modernization initiatives underline how institutional maturity strengthens the credibility and adoption of reliance models.

Good Regulatory Practices: Building Evidence-Based, Predictable Systems

Implementation of Good Regulatory Practices (GRP) has become foundational to the region’s modernization efforts. Argentina and Brazil present compelling examples of GRP integration, including:

• Enhanced labeling and risk-prevention systems informed by stakeholder engagement.
• Strong governance structures enabling public consultations, impact analyses, and transparent regulatory agendas.
• Digital tools and quality-management systems that ensure consistent, evidence-based decision-making.

Insights from the Latin American Observatory of Good Regulatory Practices further highlight gaps and opportunities. While principles such as ethics, independence, and governance are well established, challenges remain in flexibility, clarity, and sustainable financing. Successful initiatives, such as regulatory sandboxes and agile regulatory mechanisms, demonstrate that adaptive, iterative methodologies can accelerate access to innovation while maintaining safety and quality.

Collectively, these efforts strengthen institutional credibility and support the region’s integration into the global regulatory ecosystem.

Innovative Trial Designs and Operations: Enabling Smarter, Faster, Patient-Centered Research

Latin America’s strong clinical research capabilities are increasingly intersecting with global trends in agile and innovative clinical trial designs, such as master protocols, adaptive designs, surrogate variables, decentralized elements, and the strategic use of real-world evidence (RWE). While these models offer unparalleled efficiency and inclusiveness, they also demand:

• Advanced statistical expertise
• Robust digital and data-integrity infrastructures
• Clear governance of decentralized processes
• Early scientific advice and transparent regulatory-industry partnerships
• Strengthened ethics committee oversight.

Countries such as Argentina, Brazil, and Mexico are actively revising clinical trial regulations to better integrate risk-based oversight, decentralized methodologies, and ICH-aligned frameworks. These changes are essential not only to maintain competitiveness and attract global investment, but also to accelerate patient access to innovative therapies, improve trial participation opportunities, and strengthen local healthcare infrastructure.

Patient trust has emerged as a critical component of trial success, especially in rare diseases and high-complexity therapeutic areas. Persistent barriers such as limited health literacy, socioeconomic challenges, and mistrust of institutions require culturally grounded communication and meaningful patient engagement throughout study design and implementation.

Advanced Therapies and Rare Diseases: Closing Gaps and Expanding Access

Management of orphan diseases and advanced therapies remains one of the region’s most pressing challenges. Diagnostic delays, inconsistent national policies and regulatory requirements, and fragmented reimbursement systems continue to hinder access, particularly for gene and cell therapies.

Nonetheless, progress is accelerating rapidly:

• ANMAT’s dedicated ATMP framework, aligned with WHO and EMA classifications, sets a strong foundation for responsible oversight of rapidly evolving technologies.
• Regional participation in WHO convergence forums and new comparability guidance under ICH Q5 demonstrates Latin America’s active role in complying with global advanced therapy standards.
• There is urgent need for broader incentive frameworks, improved collection and use of epidemiological data, and aligned pathways like those in the US and Europe. Financial incentives and funding for clinical trial infrastructure, together with social and policy-based measures such as recognition programs, regulatory support, and public-private partnerships, are essential to accelerate advanced therapies, enhance patient access, and foster sustainable innovation across the region.

Equitable access to these therapies will require sustained multisectoral collaboration, long-term follow-up infrastructure, and innovative financing and procurement models that mitigate judicialization and cost barriers.

RWE and Pharmacovigilance Transformation: Toward Data-Driven, AI-Enabled Safety Systems

Pharmacovigilance (PV) across Latin America is transitioning from compliance-centered systems to strategic, lifecycle-based safety ecosystems supported by technology, real-world evidence, and patient partnership. Key developments include:

1. Expansion of Use of Real-World Evidence in Regulatory Decision-Making

Regulators are increasingly incorporating RWE for:

• Label expansions
• Post-marketing safety evaluations
• Benefit-risk assessments
• Market access and reimbursement decisions.

In all these areas, methodological rigor is essential, including adherence to target trial emulation, attention to the use of propensity score methods, and complying with robust reporting standards such as STROBE and ROBINS-I.

2. Data Quality and Interoperability Challenges

Despite the availability of rich data sets across Latin America, heterogeneous coding systems, limited interoperability, and inconsistent traceability limit their utility. Adopting a harmonized vocabulary, Fast Healthcare Interoperability Resources (FHIR), and common data models such as OMOP-CDM are seen as essential next steps.

3. Digital Transformation and AI in PV

AI-supported case processing, automated coding, and signal detection significantly improve accuracy and timeliness but must be paired with strong governance, human oversight, and continuous training.

4. Modernized Benefit-Risk Frameworks

In Latin America, as elsewhere, the CIOMS XII Structured Benefit-Risk Framework presents the gold standard for consistent, transparent decision-making. Its lifecycle orientation and inclusion of patient preference data are especially valuable in settings with unmet needs.

Collectively, these four advances point toward a near future where PV systems across Latin America become globally harmonized, real-time, and patient-inclusive, capable of supporting precision safety strategies across the product lifecycle.

5. Fragmentation and Convergence in Pharmacovigilance

Latin America is overcoming the historical fragmentation of its safety systems through pragmatic and technological regulatory convergence. The region is decisively advancing in the adoption of global interoperability standards, exemplified by the mandatory implementation of MedDRA and WHO Drug in Brazil and the development of “IT bridges” in Costa Rica for the automatic transfer of data to the Uppsala Monitoring Centre. Beyond data standardization, there is a robust movement toward the use of reliance mechanisms for the joint assessment of complex documents, such as Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs). This strategic shift from isolated national processes to collaborative evaluations aims to reduce the duplication of efforts and establish a unified and efficient surveillance network throughout the region.

A Region Poised for Global Leadership

The 2025 DIA Latin America Annual Meeting revealed a region increasingly aligned around common priorities:

• Strengthening institutional maturity and regulatory quality
• Accelerating the adoption of reliance and international standards
• Embedding patient-centricity in regulatory and clinical development processes
• Scaling digital and AI innovations responsibly
• Expanding the role of RWE and advanced analytics in safety and access
• Driving cross-border collaboration to reduce fragmentation and inefficiency.

Latin America is no longer a passive participant in global scientific discussions; it is emerging as an active contributor to regulatory science, innovative trial design, and safety leadership. Continued investment in capacity building, multisectoral collaboration, and evidence-based policymaking will determine how quickly this momentum translates into sustained improvements in access to innovative medicines and improved public health outcomes.

Call to Action: Advancing Regulatory and Scientific Excellence in Latin America

Latin America is at a pivotal stage in aligning regulatory practices, patient-centered innovation, and scientific rigor with global standards. Continuing and expanding dialogue among stakeholders is critical to consolidating these advances.

We encourage regulators, industry experts, researchers, healthcare professionals, and patient representatives to convene at the DIA Latin America Annual Meeting 2026 in Mexico City (September 9–11). This forum will provide an opportunity to share emerging evidence, evaluate progress in regulatory and pharmacovigilance practices, and foster collaborative approaches to scientific and policy challenges across the region. Join us and contribute to shaping the next phase of evidence-driven decision-making, regulatory convergence, and patient-centered healthcare solutions in Latin America.