Brazil Regulatory Authority - ANVISA – Regulatory Challenges - PowerPoint PPT Presentation

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Brazil Regulatory Authority - ANVISA – Regulatory Challenges

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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. – PowerPoint PPT presentation

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Title: 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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