Health, Safety and Environment (HSE) in Brazil
The Brazilian National Health Regulatory Agency (Anvisa) has announced a new initiative to expedite the certification process for Good Manufacturing Practices (GMP). In a move towards greater regulatory reliance, Anvisa will now consider inspections conducted by equivalent foreign regulatory bodies 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 …
The Brazilian Health Regulatory Agency (Anvisa) upheld the prohibition on electronic smoking devices (ESDs), commonly known as electronic cigarettes. The decision is the outcome of a regulatory process that reviewed the regulation of these products in the country in light Read More …
ANVISA has launched Call No. 1, aimed at supporting the development of phytotherapeutic drugs, new synthetic drugs and biological products of interest to healthcare services by medical startups. Recognizing the critical need for new medications and the importance of nurturing Read More …
Importing products for clinical or technological research in Brazil requires adherence to specific codes outlined by the Brazilian Health Regulatory Agency (Anvisa). These codes facilitate the process of obtaining approval for importation, ensuring compliance with regulatory standards. Here’s a comprehensive Read More …
The Brazilian Health Regulatory Agency (Anvisa) has recently introduced new subject codes for the streamlined evaluation of medicines, biological products, vaccines, and Active Pharmaceutical Ingredient (API) Dossier Suitability Letters. These codes facilitate the use of assessments conducted by equivalent foreign regulatory authorities, enhancing regulatory confidence and Read More …
The Brazilian Health Regulatory Agency, Anvisa, has taken a significant step toward streamlining the medical device registration process. In a recent move, Anvisa announced that it will now consider analyses conducted by equivalent foreign regulatory authorities when evaluating petitions for device Read More …
The Resolution RDC No. 839/2023 by Anvisa has brought significant changes to the regulatory framework governing new foods and ingredients in Brazil. Pre-Consultation Possibility Under the new regulatory framework, companies now have the option of seeking pre-consultation with Anvisa. This pre-consultation allows them to Read More …
Brazil has been selected by the Codex Alimentarius, a joint program of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), for a study to evaluate the impact of international practices to prevent naturally occurring mycotoxins in Read More …
Brazil’s National Health Regulatory Agency (Anvisa) has announced an extension of the validity period for Good Manufacturing Practice (GMP) certificates. Medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP) will now see the validity of their certificates Read More …
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