The Impact of Anvisa Regulations on Medicines, Medical Devices, Cosmetics, and Supplements
This blog post discusses recent ANVISA regulatory changes that directly impact the industries of medicines, medical devices, cosmetics, and sanitizing products, as well as dietary supplements. The goal is to provide a practical guide for regulatory affairs companies, such as GRP Brazil, to anticipate and adjust their processes, ensuring compliance and operational efficiency.
Navigating the Regulatory Red Tape: The Crucial Role of Regulatory Affairs for Health Products and Medicines
This blog post dives into the indispensable role of Regulatory Affairs in bringing health products and medicines safely to market and ensuring their ongoing compliance. It explores the critical processes of product registration and post-market surveillance (pharmacovigilance/technovigilance), highlighting why mandatory reporting of serious and unexpected adverse events is crucial, even when initial causality assessments are “not related.” Ultimately, the article emphasizes how expert regulatory teams, like GRP Brazil, are essential partners in navigating complex regulations to ensure patient safety and business success.
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.
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.
IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
EMA Launches Early Scientific Advice Program for High-Risk Medical Devices
The European Medicines Agency (EMA) has launched a new Early Scientific Advice (ESA) program aimed at supporting the development of high-risk medical devices. This initiative seeks to provide manufacturers with timely regulatory guidance, ensuring that innovative medical technologies meet the necessary safety and efficacy standards before reaching the market.
Gluten and Food Labeling: What You Need to Know
Gluten and Food Labeling: What You Need to Know
Discover That it is Possible to Import Dental Products.
Discover That it is Possible to Import Dental Products
“Discover the critical role that packaging plays in the development of cosmetic products.”
“Discover the critical role that packaging plays in the development of cosmetic products.”