We submit DSURs. We do not list minor CMC changes in DSUR since, as you state, only significant CMC changes are required for DSUR. We hold off amending IND with minor CMC changes until we have more significant changes that warrant a CMC Amendment submission to IND.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 20-Jun-2024 11:59
From: Anonymous Member
Subject: IND Annual Report/DSUR CMC Content/Format Questions
This message was posted by a user wishing to remain anonymous
Hello Forum,
Does your company submit Annual Reports in the "conventional" format (files in eCTDs sections 1.13.1 – 1.13. 9) or do you submit DSURs (a file as per the ICH E2F format in 1.13.15)?
Does your company submit minor CMC changes with your annual report, or do you submit those in CMC amendments throughout the reporting period and only summarize the previously reported changes in the annual report or DSUR?
If you submit DSURs and submit minor CMC changes with your DSUR, how do you structure the submission? Do you list the changes being made concurrent with the DSUR in the DSUR Section 16.5 or in the eCTD in 1.13.5?
I'm struggling because the DSUR does not seem to accommodate submitting new CMC changes concurrently. The DSUR requires a summary of significant CMC changes made during the reporting period only.
Thank you in advance for your feedback.