ANVISA recognises CEPs
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At the beginning of December, a news in the EDQM website newsroom informed that the Brazilian health authority ANVISA (Agência Nacional de Vigilância Sanitária) has started to recognise 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 recognised are listed below:
- European Medicines Agency (EMA)
- Health Canada
- World Health Organisation (WHO)
- Swissmedic
- UK Medicines and Healthcare products Regulatory Agency (MHRA)
- US Food and Drug Administration (FDA)
- Australian Therapeutic Goods Administration (TGA)
Further information can be found in the newsroom on the EDQM website.
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