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.
QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force
The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process
In Brazil, clinical trials for drugs follow strict regulations, guaranteeing the safety of participants and the efficacy of the drugs being tested. The regulatory body responsible is the National Health Surveillance Agency (ANVISA), which establishes rules for conducting these studies.
China’s CDE- Guidelines for Summary of Adverse Drug Reaction Data in Labeling of Antineoplastic Drugs
China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.