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.
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.
Japan Updates Orphan Drug Designation System to Accelerate Treatments for Rare Diseases
Japan has recently implemented significant updates to its Orphan Drug Designation (ODD) system, aiming to foster the development of treatments for rare diseases. These changes, introduced in 2024, are designed to streamline the designation process, provide robust support to pharmaceutical companies, and expedite patient access to essential medications.
Stakeholders Ask FDA to Harmonize Guidelines for Oligonucleotide-Based Therapies
The biopharmaceutical industry and other stakeholders are pressuring the US Food and Drug Administration (FDA) to harmonize its regulatory guidelines for oligonucleotide-based therapies. The request aims to eliminate discrepancies in the development, manufacturing and approval requirements for these innovative treatments, which have shown great potential in the fight against various genetic and infectious diseases.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.
FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development
The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.