Overview
Post-marketing pharmacovigilance is a critical component of medicines regulation in both Brazil and the United States. While both countries share the common goal of protecting public health, their regulatory frameworks differ in reporting timelines, safety reporting systems, and approaches to risk minimization.
This Blog provides a comparative analysis of Brazilian requirements—primarily established under RDC No. 406/2020 and RDC No. 967/2025—and the U.S. pharmacovigilance model overseen by the Food and Drug Administration (FDA), with a focus on reporting timelines, VigiMed x FAERS, and risk management strategies.
Introduction
Once a medicinal product is approved and marketed, the identification of rare, delayed, or population-specific adverse events depends on effective pharmacovigilance systems. Both Brazil and the United States require Marketing Authorization Holders (MAHs) to maintain active, structured, and continuous post-marketing safety surveillance
In recent years, Brazil has made substantial progress in strengthening its pharmacovigilance framework, bringing it closer to well-established regulatory models such as that of the United States. Nevertheless, important conceptual and operational differences remain—particularly relevant for multinational companies operating in both markets.
Reporting Timelines: Brazil & United States
In Brazil, reporting timelines are clearly defined under the RDCs
- Serious adverse events, whether expected or unexpected, occurring in Brazil must be reported within 15 calendar days from the date the MAH becomes aware of the case.
- Urgent safety issues must be communicated to the Agência Nacional de Vigilância Sanitária (Anvisa) within 72 hours.
In the United States, the FDA applies a similar but more segmented approach:
- 15-day Alert Reports for serious and unexpected adverse events.
- Periodic Safety Reports that include non-serious adverse events.
- Additional timelines may apply depending on product type and lifecycle stage.
Safety Reporting Systems: FAERS vs. VigiMed
- VigiMed (Brazil)
The official electronic system used by Anvisa for submission of Individual Case Safety Reports (ICSRs)
- Mandatory for MAHs
- Compatible with the ICH E2B standard
- Designed primarily for regulatory interaction between MAHs and Anvisa
FAERS – FDA Adverse Event Reporting System (United States)
The FDA’s system for collecting and analyzing adverse event and medication error reports.
- Receives reports from companies, healthcare professionals, and consumer
- One of the largest publicly accessible pharmacovigilance databases worldwide
- Supports advanced signal detection and safety monitoring activities
Key comparison: FAERS offers greater public transparency, while VigiMed is more focused on structured regulatory reporting and oversight.
Risk Management Approaches: REMS vs. Brazilian Risk Minimization Plans
REMS – Risk Evaluation and Mitigation Strategies (FDA)
Required when the FDA determines that additional measures are necessary to ensure that a drug’s benefits outweigh its risks.
REMS may include:
- Educational programs
- Restricted distribution or prescribing
- Patient monitoring requirements
- Certification of healthcare professionals or healthcare settings
Risk Management and Risk Minimization Plans (Brazil)
Required under the RDCs for specific scenarios, such as:
- New active substances
- Vaccines and biological products
- Identified or potential safety risks
These plans combine routine pharmacovigilance activities with additional risk minimization measures when necessary.
Key comparison: the Brazilian framework is conceptually aligned with REMS but places stronger emphasis on integration with global risk management strategies and ICH principles.
Key Considerations for Multinational Companies
- Need for global harmonization of pharmacovigilance systems
- Compliance with both VigiMed and FAERS requirements
- Alignment between REMS and Brazilian Risk Minimization Plans
- Inspection readiness for both Anvisa and FDA
- Effective coordination between local and global safety teams
Conclusion
The comparison between Brazilian and U.S. post-marketing pharmacovigilance frameworks highlights Brazil’s significant regulatory evolution. Through RDC No. 406/2020 and RDC No. 967/2025, Brazil has implemented a robust system with defined timelines, modern electronic reporting tools, and strong alignment with international best practices.
Although operational differences remain—particularly regarding system transparency and reporting structure—the underlying regulatory principles are convergent: continuous safety monitoring, proactive risk management, and patient protection.
For companies operating in both markets, understanding these similarities and distinctions is essential to ensure regulatory compliance, operational efficiency, and sustained trust with health authorities.
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.