Brazil Regulatory Authority - ANVISA – Regulatory Challenges

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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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