PV Requirements in Latin American Countries
(Brazil, Mexico, Argentina, Chile, and Colombia)

Introduction

Medicines don’t stop being monitored once they’re approved—they enter a new phase of oversight known as pharmacovigilance (PV). This ongoing process is vital to safeguarding patients, detecting potential risks early, and ensuring that treatments remain both safe and effective.

But here’s the challenge: while global PV principles are widely recognized, every country adds its own layer of rules, reporting timelines, and compliance expectations. For pharmaceutical companies expanding into Latin America, this patchwork of regulations can feel complex and even overwhelming.

Brazil, Mexico, Argentina, Chile, and Colombia have well-defined pharmacovigilance requirements that companies must follow. From appointing local Qualified Persons for Pharmacovigilance (QPPVs) to meeting strict reporting deadlines and preparing for inspections, success depends on knowing the local rules inside and out.

In this article, we’ll break down the pharmacovigilance landscape across these five countries—highlighting what Marketing Authorization Holders (MAHs) need to know to stay compliant while keeping patient safety front and center.

Brazil

Regulatory Authority

In Brazil, pharmacovigilance is regulated by the National Health Surveillance Agency (ANVISA). Over the last decade, ANVISA has taken significant steps to strengthen post-marketing surveillance and align with global PV standards.

Key Requirements

• Local Qualified Person for Pharmacovigilance (QP PV or “Responsável Técnico”):
  Every marketing authorization holder (MAH) must appoint a local PV responsible person based in Brazil, fluent in Portuguese, and available 24/7.
• Pharmacovigilance System Master File (PSMF):
  Since 2019, ANVISA requires companies to maintain a Brazilian PSMF that describes the PV system, processes, and responsibilities.
• Adverse Event Reporting:
  • Serious adverse events (SAEs) must be reported to ANVISA through VigiMed, the national portal, within 15 calendar days.
  • Non-serious cases : no specific timeline.
• Periodic Safety Update Reports (PSURs):
  Required according to ANVISA’s timelines, harmonized with ICH E2C standards.
• Risk Management Plans (RMPs):
  Mandatory for new products and for high-risk medicines, adapted to the Brazilian population.

Local Considerations

Brazil emphasizes language compliance—all reports must be in Portuguese—and strict adherence to timelines. Companies often face challenges with integrating global PV systems to ANVISA’s VigiMed platform.

Mexico

Regulatory Authority

Mexico’s PV framework is overseen by the Federal Commission for Protection Against Sanitary Risks (COFEPRIS), National Pharmacovigilance Center (CNFV). The Mexican market is one of the most regulated in Latin America, with growing attention on risk minimization.

Key Requirements

• Local PV Responsible Person (Responsible Sanitary Officer / QPPV):
  The MAH must designate a Mexico-based individual with appropriate qualifications, who serves as the contact point with COFEPRIS.
• Adverse Event Reporting:
  • Serious adverse events: within 7 days if fatal and 15 days for non-fatal
  • Non-serious events: within 90 days.
  • Submissions are made via COFEPRIS’s electronic system.
• Periodic Reports:
  Periodic Safety Reports are required, following ICH guidelines, and must be adapted to local regulatory expectations.
• Risk Management Plans:
  RMPs are expected for innovative products, biologics, and products with special safety concerns.
• Literature Screening:
  Companies are expected to monitor local and international scientific literature for safety information relevant to their products.

Local Considerations

Mexico places particular emphasis on active pharmacovigilance programs. MAHs are encouraged to implement educational and risk minimization activities in hospitals and pharmacies, making collaboration with healthcare providers key.

Argentina

Regulatory Authority

In Argentina, the National Administration of Drugs, Foods and Medical Devices (ANMAT) governs PV activities. ANMAT is known for its structured pharmacovigilance system and clear national guidelines.

Key Requirements

• Local PV Responsible Person:
  A local pharmacovigilance officer must be appointed and registered with ANMAT.
• Adverse Event Reporting:
  • Serious cases: within 10 days.
  • Non-serious cases: send periodically.
  • Reports must be submitted in Spanish, using the national platform.
• Periodic Reports:
  ANMAT requires submission of periodic reports aligned with global schedules (PSURs/DSURs).
• Risk Management Plans:
  Obligatory for high-risk medicines, especially biologics and advanced therapies.
• Pharmacovigilance System Master File:
  Companies must maintain a local description of their PV system, accessible for inspection.

Local Considerations

Argentina has an established National Pharmacovigilance Network, which integrates healthcare professionals into spontaneous reporting. MAHs are expected to collaborate with this network and provide training initiatives to support reporting culture.

Chile

Regulatory Authority

In Chile, the Public Health Institute (ISP) regulates pharmacovigilance. Though the system is smaller in scale compared to Brazil or Mexico, Chile has been modernizing its PV practices rapidly.

Key Requirements

• Local QPPV:
  A Chilean pharmacovigilance responsible person must be designated.
• Adverse Event Reporting:
  • Serious events and unexpected ADRs: immediately and within 15 calendar days.
  • Non-serious events: within 30 days.
• Periodic Reports:
  Submission of PSURs is required, generally in line with ICH recommendations.
• Risk Management Plans:
  Mandatory for newly registered products and those with known safety concerns.
• PV Inspections:
  The ISP conducts audits and inspections to ensure PV compliance.

Local Considerations

Chile places a strong emphasis on post-authorization safety studies (PASS). Authorities may request local studies or surveillance programs to assess medicine safety in the Chilean population.

Colombia

Regulatory Authority

Colombia’s pharmacovigilance framework is led by the National Institute for Food and Drug Surveillance (INVIMA). In recent years, INVIMA has developed a robust PV system, aligning closely with WHO guidelines.

Key Requirements

• Local PV Officer (QPPV equivalent):
  A Colombia-based PV officer must be nominated and remain the main contact point with INVIMA.
• Adverse Event Reporting:
  • Serious events: report within 7 calendar days.
  • Non-serious events: within 15 days.
• Periodic Reports:
  PSURs are required as per global ICH timelines.
• Risk Management Plans:
  Required for new products, biologics, and when requested by INVIMA.
• PV System Documentation:
  MAHs must maintain evidence of their PV system, including SOPs and reporting workflows, available for inspection.

Local Considerations

Colombia emphasizes collaboration with healthcare providers and universities to strengthen pharmacovigilance culture. INVIMA often partners with academic institutions for surveillance programs.

Regional Trends and Challenges

While each country has its own specific requirements, several common trends are clear across Latin America:

1. Local PV Responsible Person:
   Every country requires a locally based QPPV or equivalent role, ensuring accountability within the national territory.
2. Risk Management Plans and PSMFs:
   Countries increasingly demand RMPs and PSMFs adapted to their national context, reflecting a shift toward proactive risk management.
3. Language Requirements:
   Reports must be submitted in Spanish (or Portuguese in Brazil), which means MAHs need strong local translation and reporting processes.
4. Inspection Readiness:
   Regulatory authorities in the region are strengthening their inspection frameworks, making PV audits more frequent.

Challenges for Companies

• Operational Complexity: Navigating multiple platforms (VigiMed in Brazil, COFEPRIS system in Mexico, etc.).
• Cultural and Language Barriers: Ensuring translation accuracy and local adaptation of global reports.
• Resource Needs: Many MAHs rely on local PV service providers or affiliates due to high compliance demands.

Conclusion

Pharmacovigilance in Latin America is no longer a peripheral activity—it is a central regulatory requirement, enforced by increasingly sophisticated authorities. For companies operating in Brazil, Mexico, Argentina, Chile, and Colombia, success depends on having a strong local PV presence, robust reporting systems, and a proactive approach to risk management.

Key Takeaways

• Each Latin American country has unique PV requirements, even though they share common international principles.
• Brazil and Mexico maintain some of the strictest PV timelines and inspection practices.
• Local QPPV presence is a consistent requirement across all five countries, highlighting the importance of on-the-ground expertise.
• Pharmaceutical companies must adopt a country-specific PV strategy to ensure both compliance and patient safety.

Authored By : Aya Anis
Operation & Vendor Manager, Baupharma.