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.
The Pharmaceutical Industry Calls for Expansion of the FDA’s PreCheck Program
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
Global Convergence and Predictability: ANVISA Resets the Game for Medical Devices and the 2024-2025 Regulatory Agenda
ANVISA implements a new regulatory framework for Medical Devices (RDC 848/2024), seeking international alignment, and publishes the 2024-2025 Regulatory Agenda, signaling regulatory priorities for sectors like cosmetics and medicines. Understand the impact of regulatory predictability in Brazil.
ANVISA on High Alert: The Use of Injectable Cosmetics and the Strict Enforcement of Good Manufacturing Practices in Brazil
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.
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.
ANVISA Reinforces Commitment to Drug Safety at International Pharmacovigilance Event
The Brazilian Health Regulatory Agency (ANVISA) recently participated in a major international event, where it reaffirmed its crucial role in monitoring drug safety. This blog details the main topics addressed by the Agency regarding Pharmacovigilance, the advancement in managing adverse events in Brazil, and the direct impact of these discussions on the operations and strategies of Regulatory Affairs companies in the sector.
ANVISA and the ICH: How Regulatory Harmonization Strengthens the Brazilian Pharmaceutical Sector
Brazil’s participation in the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) marks a strategic milestone for the national pharmaceutical industry. This Blog explains what the ICH is, the importance of ANVISA’s presence in this global forum, and how regulatory harmonization drives innovation and access to new treatments in the country.
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).