Leadership Transition at COFEPRIS: Regulatory Consistency Risks and the Need for Stability
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is Mexico’s national regulatory authority responsible for protecting public health by overseeing medicines, medical devices, food products, tobacco, and other health-related inputs. COFEPRIS plays a central role in ensuring product safety, authorizing market access, and establishing technical regulatory requirements across the country.
New Anvisa rules Strengthen Regulation of Biologicals, Cosmetics and Health Products
The year 2025 has proved decisive for the evolution of the health regulatory framework in Brazil. With a focus on greater safety, traceability and modernization of systems, Anvisa has published new standards, technical updates and strategic guidelines that directly impact sectors such as biological products, cosmetics and health products.
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.
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’s Anvisa approves new Remdesivir indication for Covid-19
The new indication is for adult patients who do not require supplemental oxygen and who are at risk of progressing to a severe case.
Brazil’s Anvisa and FDA Renew Declaration of Technical Cooperation
On March 8, 2022 Brazil’s Anvisa and the U.S. Food and Drug Administration (FDA) have signed a Cooperation Statement aimed at maintaining and strengthening their collaboration mechanisms.