Brazil Regulatory Authority - ANVISA – Regulatory Challenges
                     Brazil Regulatory 
Authority - 
ANVISA - 
Regulatory 
Challenges
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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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