Regulatory Open Forum

 View Only
  • 1.  ANVISA Regulations for Annual Reports

    Posted 24-Mar-2023 13:19

    Hello, I am looking for ANVISA's Regulations on Annual Reports and what is required at minimum to be submitted. If possible, I am looking for something similar to the FDA guidelines, if it exists. I have searched ANVISA's site but have not found the guidelines. Thank you.



    ------------------------------
    Olivia Combs
    Valdosta GA
    United States
    ------------------------------


  • 2.  RE: ANVISA Regulations for Annual Reports

    Posted 27-Mar-2023 10:47

    Hello Olivia,

    We submitted a DSUR to ANVISA last year. We confirmed with our Brazilian CRO team that there are no specific regional appendices for Brazil; that the DSUR is accepted in English (rather than translating to Portuguese), and may be submitted either based on the 60-day period after the date of the ANVISA approval date or adjusted based on the timeline per ICH E2F. 

    As with any submission, we also included a cover letter, which was translated to Portuguese.



    ------------------------------
    Ashley Butler
    Associate Director, Regulatory Operations
    Cambridge MA
    United States
    ------------------------------