Brazil’s Pharmacovigilance Framework: From RDC 406/2020 to RDC 967/2025
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
RDC No. 406/2020: Brazil’s Regulatory Framework for Good Pharmacovigilance Practices
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Greater Rigor and Safety: ANVISA’s New Guidelines for Impurities and Degradation Products in Medicines
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Navigating the Frontier: The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
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.
Webinar Presents Preliminary Draft of the ICH Q3E Guideline on Impurities in Drug Products
The ICH Q3E Guideline (Impurities: Assessment and Control of Drug Substance and Drug Products) is a crucial directive aimed at harmonizing regulatory approaches for impurity control. This blog post details the main points of the preliminary draft presented in a recent webinar, discussing its impact and the need for preparation by companies, especially within the Brazilian regulatory context.
Building Transparency: FDA Experts Offer Essential Tips for Assembling SBOMs in Medical Devices
The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.
RDC 954/2024: ANVISA’s New Milestone for Simplified Drug Registration in Brazil
RDC 954/2024 represents a significant advance in the simplification and optimization of the drug registration process with ANVISA. The regulation establishes clear criteria for simplified registration, aiming for greater efficiency and agility for the regulated sector. The blog post will detail the key points of the RDC and the importance of ANVISA’s guidance for the correct application of the new rules, highlighting how GRP Brazil can help companies adapt to this new scenario.
The New Digital Frontier of Health: Understanding SaMD (Software as Medical Device) Regulation by ANVISA
The advance of technology has turned applications, platforms, and Artificial Intelligence (AI) into essential tools for diagnosis and treatment. ANVISA (Brazil’s National Health Surveillance Agency) is updating its rules to keep pace with this evolution. The focus is on RDC 657/2022, which establishes the foundation for the regulation of Software as a Medical Device (SaMD), ensuring that these digital innovations are safe and effective for the patient. The recent expansion of the target audience for the Agency’s inspection course reinforces its commitment to training and oversight in this sector.
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.
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.