Module 1 2021

25/06/2021

• The biggest difference is the handling of the data • Submissions require copies of CRFS and datasets from the outset ─ Don’t forget the Nonclinical datasets • Other additions (adjudication packages, Medwatch forms, etc.) may be requested • The Nonclinical and Clinical reports must also be submitted with a Study Tagging File (STF) ─ The STF is a mini XML backbone to manage the components of each report ─ The Clinical tagging is defined in terms of the ICH E3 sections, so it is easier if your templates use these sections Electronic submissions: Region by region – The United States (2)

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Electronic submissions: Region by region – The United States (3)

• The eCTD is also used in the IND phase ─ There is a good business case for getting the benefit of the lifecycle management capabilities of the eCTD in the IND • The FDA already allows for direct cross referencing from the NDA eCTD back to content first submitted as part of the IND

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