Health, Safety and Environment (HSE) in Brazil
The Brazilian Health Regulatory Agency (Anvisa) has introduced a new list of subject codes for primary applications related to clinical trials of Advanced Therapy Products (ATPs), aligning with the requirements of Brazil’s updated Clinical Research Law (Law 14874/2024). This change Read More …
Brazilian Health Regulatory Agency (Anvisa) approved a new regulation that updates the rules for epidemiological surveillance in Brazil’s ports and airports. This new framework aims to reduce the risk of disease transmission through travelers and cargo, especially in light of Read More …
The Brazilian Health Regulatory Agency (Anvisa) has issued a critical warning regarding the use of unapproved stem cell products, especially those promising miracle cures and treatments. As the popularity of advanced therapies grows, Anvisa is stepping up its efforts to Read More …
The Brazilian Health Regulatory Agency (Anvisa) implemented RDC 848/2024, updating the essential safety and performance requirements for medical devices. This new regulation replaces RDC 546/2021 and introduces key changes, particularly the inclusion of in vitro diagnostic (IVD) devices. By aligning Read More …
Brazil’s Ministry of Health has introduced new guidelines aimed at accelerating medical innovation in Brazil. Published on August 23, 2024, these guidelines are part of a broader initiative to modernize the regulatory environment, facilitating the swift entry of medical and Read More …
Brazilian Health Regulatory Agency (Anvisa) has approved a new regulation establishing the National Prescription Control System (SNCR) to enhance the management and numbering of prescriptions for controlled medications in Brazil. This measure aims to improve the tracking and security of Read More …
Brazil’s National Health Regulatory Agency (ANVISA), has introduced new subject codes to facilitate the registration and updating of pre-pandemic influenza vaccines. These codes align with Resolution RDC No. 846/2024, which outlines the conditions and procedures for registering and updating vaccine strains Read More …