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
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.