Brazil Regulatory Body ANVISA recognizes CEPs:
EDQM website newsroom announced that the Brazilian health authority ANVISA has started to recognize evaluation reports and docum1ents from other authorities as a part of its assessments.
In the early December 2024 a news in the EDQM website newsroom informed that the Brazilian health authority ANVISA (Agência Nacional de Vigilância Sanitária) has started to recognize evaluation reports and documents from other authorities as part of its assessments. This includes, for example, the CEP of the EDQM, which can now be used when applying for the “Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA)” and can therefore provide support when applying for medicinal products in Brazil.
Other authorities whose evaluations are now recognized are listed below:- European Medicines Agency (EMA)
- Health Canada(HC)
- World Health Organization (WHO)
- Swissmedic
- UK Medicines and Healthcare products Regulatory Agency (MHRA)
- US Food and Drug Administration (FDA)
- Australian Therapeutic Goods Administration (TGA)
At Masuu Global, we provide expert support in navigating these regulatory changes for seamless market access.
Reference: https://www.edqm.eu/en/-/increasing-the-edqm-s-global-impact-brazilian-health-authority-to-rely-on-cep-evaluation-procedure