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Harmonization of regulatory requirements for approval of medicines: a Brazilian perspective.

  • At: 2018 FIP Congress in Glasgow (Scotland)
  • Type: Presentation
  • By: SANTOS, Gustavo (ANVISA, Brazil)
  • Co-author(s): Gustavo Mendes Lima Santos:Safety and Efficacy Manager,Anvisa,Brasilia,Brazil
  • Abstract:

    Challenge associated with harmonization is the need to consider diverse regional realities in order to define requirements, which may result in different approaches based in economics, politics or technological contexts. Anvisa, which is the Brazilian regulatory agency has been playing a leading role in regional harmonization forums and taking


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Last update 4 October 2019

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