Latin America is making significant progress toward regulatory harmonization in 2025. Authorities across the region are working to align standards and approval procedures—especially in pharmaceuticals, biotechnology, and sustainability—reducing fragmentation, speeding up evaluations, and strengthening regional competitiveness.
Health & Medical Products: Agencies are expanding joint dossier reviews, enhancing pharmacovigilance, and accelerating product registrations.
Agriculture & Biotechnology: More uniform rules on GM crops and animal health are boosting research, investment, and regional trade.
Environment & ESG: Countries are adopting standardized frameworks for emissions, renewable energy, and sustainable supply chains, aligning more closely with global ESG expectations.
Despite the progress, challenges remain, including uneven regulatory capacity, diverse legal systems, and the absence of full mutual recognition for inspections and approvals. Experts emphasize that continuous collaboration, digitalization, and structural investment will be essential to fully consolidate harmonization in the region.
TrustCert continues to monitor and support regulatory developments across LATAM to ensure clarity, compliance, and timely market access.
