Health, Safety and Environment (HSE) in Brazil
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 …
In the ever-evolving landscape of public health and safety, the Brazilian Health Regulatory Agency (Anvisa) plays a critical role in safeguarding the well-being of its citizens. The agency’s recent initiative to enhance transparency in its drug evaluation process is a Read More …
During its public Collegiate Board meeting on March 19, 2024, Anvisa approved an instructional norm aimed at establishing criteria for the use of assessments from foreign equivalent regulatory authorities within its framework. This recent Anvisa approval represents a significant milestone Read More …
Regulatory agencies play a vital role around the world in ensuring the safety and efficacy of food, drugs and medical devices. While many are familiar with the Food and Drug Administration (FDA) in the United States, Brazil has its own Read More …
On March 6th, the Brazilian Health Regulatory Agency (Anvisa) approved a new resolution addressing the essential safety and performance requirements for medical devices and in vitro diagnostic devices (IVD). This significant development comes as a response to the evolving landscape Read More …
The Brazilian Health Regulatory Agency (Anvisa) recently released the 6th edition of its Questions and Answers document on materials in contact with food. This updated version incorporates changes resulting from regulatory updates and has been adjusted to provide clearer responses. Read More …