Overview
This blog post explores the critical guidelines established by RDC 406/2020, which regulates Good Pharmacovigilance Practices (GVP) for Marketing Authorization Holders (MAH) in Brazil. We will break down the responsibilities, the required organizational structure, and how compliance with these ANVISA standards ensures safety within the Brazilian pharmaceutical market.
Introduction
In December the Agency has taken a decisive step toward international harmonization by detailing the implementation of new adverse event terminology based on IMDRF standards.
The message is clear: the “language” of Techno vigilance has changed. The way we describe, code, and report failures and incidents with medical devices in Brazil is undergoing a profound restructuring to align with the world’s leading regulators.
The Qualified Person for Pharmacovigilance (QPPV)
The regulation requires the appointment of a Qualified Person for Pharmacovigilance (known in Brazil as the Technical Manager for Pharmacovigilance). This professional must have:
- Technical autonomy.
- Direct access to company management.
- The role of being the primary point of contact with ANVISA.
The Pharmacovigilance System Master File (PSMF)
The MAH must maintain a Pharmacovigilance System Master File (PSMF). This document serves as the “biography” of the company’s safety operations, detailing:
- Organizational structure and delegated activities.
- Workflows for receiving and processing adverse events.
- Signal management and risk assessment processes.
Risk Management and Periodic Benefit-Risk Evaluation Reports (PBRER)
Under GRP Brazil, reactivity is replaced by proactivity. RDC 406/20 emphasizes two main tools:
- Risk Management Plan (RMP): Identifying and mitigating potential risks before they cause harm.
- PBRER (locally known as RPPS): These reports replace old-style safety updates, focusing on a critical analysis of the benefit-risk balance rather than just a list of cases.
Quality Management and Inspections
Pharmacovigilance must be integrated into a Quality Management System. This includes updated Standard Operating Procedures (SOPs), continuous training, and internal audits to ensure the system is robust enough to withstand ANVISA inspections.
Conclusion
RDC 406/2020 has significantly raised the bar for drug safety in Brazil, integrating the country into the world’s best Good Pharmacovigilance Practices (GRP). For companies, compliance is more than avoiding fines—it is about sustaining the trust of healthcare providers and patients. Implementing these practices effectively ensures product longevity and, most importantly, protects the lives of those who use them.
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
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa.
- National Health Surveillance Agency. Resolution RDC No. 406, of July 22, 2020. Establishes Good Pharmacovigilance Practices for Marketing Authorization Holders.
- ANVISA. Guide No. 32/2020 – Pharmacovigilance Guide for Marketing Authorization Holders.
- Pan American Health Organization (PAHO). Good Pharmacovigilance Practices for the Americas.
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.