How to cope with Brazil's ANVISA Regulatory Challenges

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How to cope with ANVISA's Regulatory Challenges
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Brazil Regulatory AuthorityANVISA 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.

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Brazil Regulatory AuthorityANVISA Regulatory
Challenges

• 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.
• ANVISAs registration process is often compared
  to that of the registration process of the US FDA
  because of certain uncanny resemblance.

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Brazil Regulatory Authority ANVISA Regulatory
Challenges

• In case of drugs the updated norms indicate that
  every drug and Active Pharmaceutical Ingredients
  (APIs) whether manufactured in Brazil or has been
  imported needs to be registered under ANVISA.
  This is an established regulatory system that has
  been running over the years but still there is
  extreme complexity surrounding the registration
  process under the same.
• ANVISA is a new ICH member and thus is going
  through a revision process of all guidelines.
  Most updated guidelines under this regulatory
  authority is presented in a detailed manner and
  with a proper structure which prevents
  manufacturers from taking the risk.

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Challenges Faced by ANVISA

• Challenges Highlighted by ANVISA
• Solution for Regulatory Challges
• Read now at
• Brazil Regulatory Authority
• ANVISA Regulatory Challenges

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