Health, Safety and Environment (HSE) in Brazil
The Brazilian Health Regulatory Agency (Anvisa) has introduced regulations aimed at bolstering public health defenses and operational efficiency in ports, airports, and customs facilities. The updated rules, outlined in Resolutions RDC 932/2024, RDC 938/2024, and RDC 939/2024, mark significant advancements Read More …
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 …
The Brazilian Health Regulatory Agency (Anvisa) recently introduced RDC 894/2024, a new regulation aimed at enhancing post-market monitoring of cosmetic products in Brazil. This regulation, which comes into effect in 12 months, outlines stringent guidelines for ensuring consumer safety through 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 …
The Brazilian National Prescription Monitoring System (SNCR) is now in effect in Brazil, modernizing the management of controlled medications. Established by the RDC 873/2024, the system became operational on July 18, 2024, and is now available for use by Health Read More …
The Brazilian Health Regulatory Agency (Anvisa) has issued a crucial clarification regarding the use of phosphoethanolamine for cancer treatment. Despite widespread discussions and misinformation, phosphoethanolamine is not authorized or registered for use as a dietary supplement or medication in Brazil. Read More …
The Farmacopeia Brasileira announced the Call for Contributions No. 10/2024, aimed at enhancing the evaluation of pharmaceutical specialties through dissolution testing. This initiative seeks input from the production sector and educational and research institutions to support the inclusion of these Read More …