ANVISA explains how drug safety is assessed in the pharmacovigilance cycle
Pharmacovigilance is essential to ensure that medicines marketed in Brazil continue to be safe and effective over time. Even after approval and market entry, these products continue to be monitored through a structured cycle that involves detecting adverse events, analyzing risks and adopting corrective measures. In this blog, you will understand how this process coordinated by ANVISA works, what the roles of each agent involved are and why the participation of society is so important.
COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies
Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.
ANVISA Opens Public Consultation on New Regulatory Framework for Medical Devices in Brazil
Brazil’s national health surveillance agency, ANVISA, has launched a targeted public consultation as part of its effort to revise and modernize the regulatory framework for medical devices. This initiative aims to align Brazilian regulations with international best practices, enhance patient safety, and foster innovation. Stakeholders across the health and regulatory sectors are invited to submit their contributions and insights.
Brazil Discusses Revisions to Allergen Labeling on Food Products
Clear and accurate food labeling is essential for protecting consumers, especially those with food allergies. To improve transparency and safety, ANVISA recently held a virtual sectoral dialogue to discuss the revision of Brazil’s allergen labeling regulations. The initiative aims to update current standards, improve clarity for consumers, and align Brazilian practices with international regulatory trends.
Brazil Approves New Composition for Seasonal Influenza Vaccines
Annual influenza vaccination is one of the most effective strategies for preventing respiratory complications and reducing hospitalizations caused by the flu virus. Each year, the vaccine composition must be updated based on the most recent circulating strains. In 2025, ANVISA approved a new regulation defining the composition of seasonal influenza vaccines to be used in Brazil, aligning the country with World Health Organization (WHO) recommendations.
New Guidance on Forced Degradation Studies for Medicines in Brazil
The stability of medicines is one of the fundamental pillars to ensure their efficacy, safety, and quality throughout their shelf life. In this context, forced degradation studies are essential tools for drug development and stability assessment. Recently, Anvisa published new guidance establishing clear directives for conducting these studies in Brazil, providing greater consistency and transparency for the pharmaceutical industry.