Mastering RDC 406/2020 – Good Pharmacovigilance Practices in Brazil
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.
ANVISA Clarifies the Unification of Petition Subject Codes for GMP Certification (CBPF)
The Brazilian Health Regulatory Agency (ANVISA) recently published an official clarification regarding the unification of petition subject codes used for submissions related to the Certificate of Good Manufacturing Practices (CBPF) for medical devices.
Brazil x United States: A Comparison of Post-Marketing Pharmacovigilance Requirements (RDCs x FDA)
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.
Regulatory Priorities of Anvisa for 2026–2027: Efficiency, Agility, and Backlog Reduction in Regulatory Processes
As Brazil enters the 2026–2027 regulatory cycle, Anvisa has placed regulatory efficiency, backlog reduction, and process modernization at the center of its strategic agenda. This article outlines the agency’s main regulatory priorities and analyzes their expected impact on companies operating in the Brazilian life sciences and healthcare sectors.
Brazil’s Pharmacovigilance Framework: From RDC 406/2020 to RDC 967/2025
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.
RDC No. 406/2020: Brazil’s Regulatory Framework for Good Pharmacovigilance Practices
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.
Greater Rigor and Safety: ANVISA’s New Guidelines for Impurities and Degradation Products in Medicines
The National Health Regulatory Agency (ANVISA) has published a new set of guidelines regarding the classification, identification, and control of impurities and degradation products in medicines. This update is crucial for the pharmaceutical industry as it establishes clearer and more rigorous criteria for demonstrating product safety and quality. The focus of the new guidelines is to harmonize national practices with international guidelines and ensure that acceptable limits for these substances are consistently monitored throughout the drug’s lifecycle, from production to expiration date.
Navigating the Frontier: The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
The incorporation of Artificial Intelligence and Machine Learning (AI/ML) into medical devices has the potential to revolutionize diagnosis, treatment, and health management. However, the adaptive and constantly evolving nature of these algorithms challenges traditional regulatory frameworks. This article provides an overview of the complex and dynamic global regulatory landscape—with a focus on leading agencies like the FDA (USA) and the European Union (EU)—highlighting the main challenges and the innovative approaches being developed to ensure the safety and effectiveness of these “learning” devices.
Registration of Medical Devices in Brazil: Understanding Risk Classes and Regulatory Requirements
To market medical devices in Brazil — from surgical materials to diagnostic equipment — companies must register them with Anvisa, the National Health Surveillance Agency. Brazil classifies these products into four risk classes (I to IV), which determine the level of regulatory control and documentation required. In this article, you’ll learn how Brazil defines medical device risk classes and what is required to bring each type to market.
Registering Cosmetics with Anvisa: Practice Guide for 2025
The regularization of cosmetics in Brazil goes through specific processes defined by Anvisa. With the entry into force of RDC 752/2022, the procedures have become clearer and more digital, but still require attention to detail. This updated guide for 2025 presents a step-by-step process for registration (or notification), explains the risk categories and provides essential tips for avoiding rework.
Toxicology and Safety in Cosmetics: Current Regulatory Requirements
The safety of cosmetics is a growing priority for both regulators and consumers. In Brazil, Anvisa establishes clear guidelines on toxicological evaluation and safety requirements for ingredients and finished products. This article explores what is currently required, with a focus on RDC 752/2022, addressing critical points for companies and professionals working in the sector.
RDC 954/2024 -Comprehending the Highlights and Impacts on Drug Registration
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution, RDC 954/2024 introduces several updates to make the drug registration process more agile and in line with international standards. .