Health, Safety and Environment (HSE) in Brazil
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 …
The National Health Regulatory Agency (Anvisa) of Brazil has recently released an updated edition of its document addressing nutritional labeling, titled “Questions and Answers on Nutritional Labeling.” This document aims to clarify the new regulatory requirements and ensure that food Read More …
The National Health Regulatory Agency (Anvisa) has taken a significant step towards modernizing healthcare information by approving a pilot project for digital medication leaflets. This initiative aims to enhance patient access to medication information while ensuring accuracy and convenience. Key Read More …
Brazilian Health Regulatory Agency (Anvisa) has enacted a ban on the sale and use of phenol-based products in both general health and aesthetic procedures. This prohibition was formalized under Resolution No. 2384, issued on June 24, 2024. The decision comes Read More …
The National Health Regulatory Agency (Anvisa) has issued a critical safety report highlighting the adverse reactions associated with cosmetic products. This is part of Anvisa’s ongoing cosmetovigilance efforts to ensure consumer safety and to monitor the cosmetic market effectively. Key Read More …
Brazilian Health Regulatory Agency (Anvisa) has updated its guidelines to simplify regulatory procedures and recude costs for the sanitation product sector. The new measure simplifies the process of altering labels on sanitation products meant for donation. This decision is encapsulated Read More …
The Brazilian Health Regulatory Agency (Anvisa) issued Normative Instruction (IN) 292/2024, outlining the criteria and specific procedures for defining Equivalent Foreign Regulatory Authorities (AREEs) in sanitary inspections. This norm also establishes an optimized analysis procedure for Good Manufacturing Practices (GMP) Read More …
Brazil’s National Health Regulatory Agency (Anvisa) published RDC 876/2024, which modifies the existing regulation on registration changes and the cancellation of biological products, previously governed by RDC 413/2020. This update aims to streamline the protocol process for updating the registration Read More …
The Brazilian Health Regulatory Agency (ANVISA) has recently announced the publication of Resolution of the Collegiate Board (RDC) 860/2024. This new regulation updates RDC 16/2014, which outlines the criteria for obtaining Authorization to Operate (ATO) and Special Authorization for companies. Read More …