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.
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Ashley Butler
Associate Director, Regulatory Operations
Cambridge MA
United States
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Original Message:
Sent: 24-Mar-2023 13:19
From: Olivia Combs
Subject: ANVISA Regulations for Annual Reports
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.
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Olivia Combs
Valdosta GA
United States
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