From Fragmentation to Integration: A Strategic Review of Pharmacovigilance Systems Across LATAM

Pharmacovigilance systems across Latin America exhibit significant diversity in structure, regulatory rigor and integration with global standards. Understanding these variations is essential for Marketing Authorization Holders seeking to maintain compliance and optimize safety operations in the region.

This overview groups countries by PV system maturity – ranging from highly developed frameworks aligned with international best practices to emerging systems that rely heavily on regional and global support. It also highlights unique cases such as Puerto Rico, where U.S. FDA oversight applies.

By examining these profiles, organizations can identify compliance priorities, anticipate regulatory challenges, and explore opportunities for harmonization and integration to strengthen pharmacovigilance governance across Latin America.

Regional Profiles: Grouped Overview by PV System Maturity

Mature Frameworks: Aligned with Global Standards

Several countries in Latin America – such as Argentina, Brazil, Mexico, Colombia, Chile, Peru – and French Guiana have developed mature PV systems aligned with international best practices. These jurisdictions generally require formal appointment of a Local Person for Pharmacovigilance and the maintenance of a local Pharmacovigilance System Master File. Regulatory bodies including ANMAT (Argentina), ANVISA (Brazil), and COFEPRIS (Mexico) actively enforce these requirements through routine inspections.

Argentina and Brazil mandate that the LPPV must be an employee of the Marketing Authorization Holder, while Mexico strengthens its framework by requiring PV-specific training or certification for LPPVs. French Guiana adheres to European Union PV regulations under the oversight of France’s ANSM.

In 2025, Mexico introduced significant regulatory reforms through COFEPRIS, aimed at global harmonization, fostering innovation, and accelerating patient access to medicines. These changes include faster initiation of clinical trials and product registrations, enhanced adverse event monitoring systems, and initiatives to improve public awareness.

A notable example of regulatory vigilance occurred in early 2025 in Argentina when ANMAT suspended fentanyl production at a manufacturer following a December 2024 inspection that revealed critical deficiencies. These lapses were linked to a contamination incident resulting in nearly 100 fatalities in Argentina. This case underscores the essential role of timely PV inspections and strict enforcement in preventing patient harm.

Ultimately, this incident reflects the advanced oversight capabilities of regional authorities and reinforces the imperative for Marketing Authorization Holders to maintain fully compliant PV systems. Strong governance and adherence to global standards remain fundamental to safeguarding patient safety and sustaining regulatory trust.

Semi-Structured Systems: Evolving but Operational

In contrast, semi-structured PV systems in countries like Ecuador, Bolivia, Costa Rica, Guatemala and others remain operational but less proactive. While most expect a local PV contact, requirements for formal nomination and PSMF documentation are often flexible or informal. Ecuador is an exception, mandating a local PSMF, whereas other countries typically request documentation only during inspections. These frameworks reflect gradual regulatory evolution, supported by regional harmonization initiatives, but pose higher compliance risks compared to mature systems.

For Marketing Authorization Holders, these differences underscore the need for tailored compliance strategies – ensuring robust PV governance in mature markets while proactively preparing for evolving requirements in semi-structured systems to mitigate regulatory and patient safety risks.

Emerging Systems: Limited Formalization, Regional Dependence

Belize, Cuba, Guyana, Suriname, Venezuela, and Haiti operate pharmacovigilance programs with basic infrastructure. LPPV requirements are informal, and none mandate a local PSMF. Instead, pharmacovigilance activities are largely supported by international and regional initiatives, including WHO’s Programme for International Drug Monitoring (PIDM), PAHO-led projects, and sentinel site networks. Although data availability varies across these countries, all demonstrate a commitment to pharmacovigilance through global partnerships. However, heavy reliance on regional data and minimal local legislation can create challenges for timely compliance and effective risk management.

U.S.-Aligned Oversight

Puerto Rico falls under the jurisdiction of the U.S. Food and Drug Administration (FDA). There are no localized LPPV requirements, and pharmacovigilance obligations – including reporting, documentation and adverse event submissions are managed via the FDA’s national system.

The FDA’s San Juan District Office provides local regulatory oversight, while the Puerto Rico Department of Health supports product registration and representation. The integration within FDA frameworks allows streamlined compliance but requires familiarity with federal guidelines rather than regional laws.

Strategic Observations

• Only a select few LATAM countries (e.g. Argentina, Brazil, Mexico) impose both formal nomination and employee requirements for LPPVs, making them stricter than others.
• The presence of a local PSMF is common among countries with advanced PV systems, while emerging markets rely on flexible documentation expectations.
• Participation in WHO PIDM allows signal sharing and international support, but does not equate to harmonized enforcement.
• Integration tools such as VigiFlow and VigiLyze – developed by the Uppsala Monitoring Centre – are increasingly used to standardize safety reporting and improve surveillance, particularly in countries like Mexico and Colombia.

Conclusion

Pharmacovigilance in Latin America is characterized by diverse regulatory maturity – from highly structured frameworks aligned with global standards to emerging systems reliant on regional and international support. While mature markets demand rigorous compliance and proactive governance, semi-structured and emerging systems require flexibility and foresight to navigate evolving expectations and mitigate risks. Puerto Rico’s FDA-aligned oversight adds another layer of complexity, emphasizing the need for familiarity with U.S. federal requirements.

For Marketing Authorization Holders, this variability underscores the importance of tailored strategies and integrated PV systems that ensure compliance across all jurisdictions. By harmonizing processes, leveraging regional expertise, and anticipating regulatory shifts, companies can transform pharmacovigilance from a compliance obligation into a strategic advantage – protecting patients, safeguarding reputation, and enabling sustainable growth in a dynamic LATAM landscape.