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Brazil Regulatory Authority - ANVISA – Regulatory Challenges

The Brazilian Health Surveillance Agency, commonly known as ANVISA, abbreviated from Portuguese u201cAgencia Nacional de Vigilancia Sanitaria,u201d is the food and drug regulatory agency in Brazil. In the federal public regulatory structure, the agency is connected to the Ministry of Health. ANVISA has a particular process in which they undertake regulatory submissions. Over the years there have been several changes to these guidelines and the greatest challenge faced by bio and pharmaceutical companies in this regards is their lack of proper knowledge.<br>

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Brazil Regulatory Authority - ANVISA – Regulatory Challenges

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  1. Brazil Regulatory Authority - ANVISA- Regulatory Challenges

  2. Brazil Regulatory Authority - ANVISA – Regulatory Challenges The Brazilian Health Surveillance Agency, commonly known as ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. In the federal public regulatory structure, the agency is connected to the Ministry of Health. ANVISA has a particular process in which they undertake regulatory submissions. Over the years there have been several changes to these guidelines and the greatest challenge faced by bio and pharmaceutical companies in this regards is their lack of proper knowledge.  Second visible challenge with ANVISA is that the regulations are present only in two languages, one is Portuguese and the other is English. The English version is not for all the content and hence it might be difficult for those without knowledge of Portuguese to comprehend. 

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