FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval
The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).
Strengthening Health in Latin America: Brazil and Mexico Join Forces in Historic Agreements
In a strategic move to strengthen public health in Latin America, Brazil and Mexico are advancing negotiations to sign important bilateral agreements. Preliminary discussions, which took place in August, involved a Brazilian delegation led by Vice President Geraldo Alckmin and the Mexican government, led by President Claudia Sheinbaum. The main focus of these agreements is cooperation in key areas such as vaccines, medicines, and regulatory harmonization. The final agreements are expected to be signed in 2026.
Anvisa’s Regulatory Agenda and Strategic Plan
This Blog analyzes the importance of ANVISA’s 2024-2025 Regulatory Agenda and its 2024-2027 Strategic Plan for companies operating in regulatory affairs. The text explains how these documents serve as a planning guide, helping companies anticipate new regulations and align their strategies to ensure compliance and operational efficiency.
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.