Presentation: Overview of Drug Registration in Brazil

Reviewed Topics:

  • Definitions
  • Different Steps of Drugs Registration in Brazil
    • Step 1: Preparation and Submission of Registration Dossier to Anvisa Structure of Registration Dossier Content of Registration Dossier
    • Step 2: ANVISA GMP Inspection of Manufacturing Sites
    • Step 3: Local testing
  • ANVISA Review Timelines