Overview
Brazil has undergone a significant regulatory evolution in pharmacovigilance over the past few years. With the publication of RDC No. 406/2020, the country established a consolidated framework for Good Pharmacovigilance Practices applicable to Marketing Authorization Holders (MAHs). In 2025, this framework was further strengthened by RDC No. 967/2025, reinforcing governance, risk-based oversight, and international harmonization.
Together, these regulations position Brazil among jurisdictions with mature post-marketing surveillance systems, aligned with global pharmacovigilance standards while preserving local regulatory specificities under the supervision of Agência Nacional de Vigilância Sanitária (Anvisa).
Introduction
Pharmacovigilance plays a critical role in ensuring that the benefits of medicinal products continue to outweigh their risks after-market authorization. Historically, Brazilian pharmacovigilance requirements were fragmented across multiple resolutions and instructions.
The introduction of RDC No. 406/2020 marked a turning point, consolidating obligations, defining clear roles for MAHs, and introducing structured systems for adverse event reporting, risk management, and benefit–risk evaluation. Five years later, RDC No. 967/2025 builds upon this foundation, reflecting regulatory maturity, inspection experience, and convergence with international best practices.
This blog explores the regulatory evolution from RDC 406/2020 to RDC 967/2025 and outlines what MAHs should expect in Brazil from 2025 onward.
Regulatory Highlights
- Consolidation and Maturity of the Pharmacovigilance System
- RDC 406/2020 established the mandatory Pharmacovigilance System, including databases, SOPs, training programs, self-inspections, and contingency planning.
- RDC 967/2025 reinforces system robustness, emphasizing data integrity, traceability, and inspection readiness across all pharmacovigilance processes.
- Strengthened Accountability of Marketing Authorization Holders
Both regulations confirm that MAHs remain fully responsible for pharmacovigilance activities, even when outsourced.
RDC 967/2025 places additional emphasis on:
- Clear contractual arrangements
- Oversight of third-party vendors
- Demonstrable governance and quality control mechanisms
- Enhanced Role of the Pharmacovigilance Responsible Person
- RDC 406/2020 introduced the mandatory Pharmacovigilance Responsible Person (PRP) residing in Brazil.
- RDC 967/2025 strengthens expectations regarding:
- Decision-making authority
- Availability during inspections and safety crises
- Active involvement in risk management and benefit–risk evaluations
- Risk-Based and Proactive Safety Management
RDC 967/2025 expands on concepts introduced in RDC 406/2020 by reinforcing:
- Continuous benefit–risk evaluation
- Signal detection and management
- Integration between pharmacovigilance, quality deviations, and regulatory actions
- More structured oversight of Risk Management Plans and Risk Minimization Measures
International Impact and Alignment with ICH
Brazil’s pharmacovigilance framework demonstrates increasing convergence with guidelines issued by the International Council for Harmonization (ICH), particularly:
- ICH E2B – Standardized electronic submission of Individual Case Safety Reports (ICSRs), supporting global data exchange.
- ICH E2C – Periodic Benefit–Risk Evaluation Reports (PBRER), reinforcing lifecycle-based safety assessment.
- ICH E2E – Risk Management Plans structured around identified and potential risks, with defined minimization measures.
RDC 967/2025 further strengthens this alignment by emphasizing risk-based oversight, signal management, and the integration of global safety data into local regulatory decision-making. This approach reduces regulatory fragmentation and facilitates compliance for multinational MAHs operating across multiple jurisdictions.
Conclusion
The transition from RDC 406/2020 to RDC 967/2025 reflects the natural evolution of Brazil’s pharmacovigilance system—from consolidation to regulatory maturity. Together, these regulations establish a comprehensive, risk-based, and internationally aligned framework that prioritizes patient safety while providing regulatory clarity.
For Marketing Authorization Holders, 2025 and beyond will require:
- Strong governance structure
- Proactive safety surveillance
- Robust documentation and inspection readiness
- Alignment between global pharmacovigilance systems and Brazilian regulatory expectations
Brazil is no longer an emerging player in pharmacovigilance—it is an active participant in the global safety ecosystem, with regulations that increasingly speak the same language as leading international authorities.
GRP Brazil
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References
Learn more about Anvisa.
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.