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.
Global Techno vigilance: What changes with Anvisa’s adoption of IMDRF terminology
The Implementation of standardized IMDRF (International Medical Device Regulators Forum) codes for adverse event reporting.
Required Action: Update Standard Operating Procedures (SOPs) and Quality Management Systems (QMS).
Towards Sanitary Sovereignty: The Infliximab API and the Challenge of National Production
The recent authorization by Anvisa (Brazil’s Health Regulatory Agency) for the national production of the Active Pharmaceutical Ingredient (API) of infliximab by Bionovis marks a strategic step for the health and national security of Brazil. The biopharmaceutical, essential for treating autoimmune diseases, symbolizes the effort to reverse the critical dependence on imported inputs, which currently accounts for about 95% of the total. This article explores the historical importance of this recovery, the structural and professional capacity challenges involved, and the crucial role of policies such as the Productive Development Partnerships (PDPs) for the rebirth of the Health Economic-Industrial Complex (CEIS).
Customs Revolution: ANVISA’s Phased Adherence to the New Import Process
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
The Shadow of Irregularity: Unregistered Medicines and Hair Cosmetics and the Hidden Risks
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
Global Convergence and Predictability: ANVISA Resets the Game for Medical Devices and the 2024-2025 Regulatory Agenda
ANVISA implements a new regulatory framework for Medical Devices (RDC 848/2024), seeking international alignment, and publishes the 2024-2025 Regulatory Agenda, signaling regulatory priorities for sectors like cosmetics and medicines. Understand the impact of regulatory predictability in Brazil.