Overview
Issued by the Agência Nacional de Vigilância Sanitária (Anvisa), RDC No. 406/2020 establishes the requirements for Good Pharmacovigilance Practices (GVP) applicable to Marketing Authorization Holders (MAHs) of human medicines in Brazil.
The regulation defines responsibilities, organizational structures, systems, timelines, and technical standards to ensure continuous post-marketing safety monitoring of medicinal products, aligning Brazil with internationally recognized pharmacovigilance practices.
Introduction
Pharmacovigilance is a cornerstone of modern health regulation. With the publication of RDC No. 406/2020, Brazil consolidated previously fragmented requirements into a single, comprehensive framework.
This regulation reinforces the proactive role of MAHs in detecting, evaluating, understanding, and preventing adverse events, ensuring that the benefit–risk profile of medicinal products is continuously assessed throughout their entire lifecycle.
Key Regulatory Highlights
Full responsibility of the Marketing Authorization Holder
- MAHs remain legally responsible for all pharmacovigilance activities related to their products, even when activities are outsourced.
Mandatory appointment of a Pharmacovigilance Responsible Person (PRP)
- The PRP must reside in Brazil, have a healthcare background, proven pharmacovigilance experience, and sufficient authority to interact with Anvisa.
Structured Pharmacovigilance System
- Including a safety database, formal documentation, SOPs, training programs, self-inspections, and contingency plans.
Mandatory reporting of serious adverse events
- Serious adverse events occurring in Brazil must be reported to Anvisa within 15 calendar days via the VigiMed electronic system.
Mandatory use of MedDRA
- All adverse events must be coded using the internationally recognized MedDRA dictionary.
Periodic Benefit–Risk Evaluation Reports (PBRERs)
- All adverse events, including those occurring outside Brazil, must be assessed and included.
Risk Management Plan (RMP)
- Required in specific scenarios such as new active substances, vaccines, biological products, major post-approval changes, or upon regulatory request.
International Impact and ICH Alignment
RDC No. 406/2020 shows strong convergence with guidelines issued by the International Council for Harmonization (ICH), particularly:
- ICH E2B – Standardized electronic transmission of Individual Case Safety Reports (ICSRs) in XML format.
- ICH E2E – Risk Management Plan structure, including risk identification, minimization measures, and ongoing monitoring.
- ICH E2C – Periodic Benefit–Risk Evaluation Reports, aligned with PSUR/PBRER concepts.
This harmonization facilitates global compliance for multinational companies and strengthens Brazil’s integration into international pharmacovigilance systems.
Conclusion
RDC No. 406/2020 represents a major regulatory milestone for pharmacovigilance in Brazil. By introducing a structured, risk-based, and internationally aligned framework, the regulation enhances patient safety and regulatory predictability.
For MAHs, compliance requires governance, technical expertise, and a strong safety culture—but ultimately reinforces trust in medicinal products and Brazil’s regulatory environment.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
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Email: info@globalregulatorypartners.com
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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.