The document discusses how to handle grouping and worksharing in eCTD submissions. It outlines changes to the eCTD specification related to variations, and the challenges this poses for business processes and dossier compilation across multiple products. Practical experience with lifecycle complexities, cover letter authorizations, and preparation timelines for grouped/workshared submissions is also examined.

1. The Science of Submissions Part IB How to handle grouping and worksharing in eCTD Hans van Bruggen eCTDconsultancy

3. NVR-related changes to the eCTD specification

6. or or Associates cross product submissions together - assigned by agency (if unknown use “ to be assigned”) Required for all submissions, replaces Application number e.g. “EMEA/H/124/IA/04”, if unknown use “to be advised” Only required for variations or extensions Copyright eCTDconsultancy B.V. Grouping and worksharing in eCTD submissions require a: all Cross-product submissions require a: Submission Mode Submission Number “ Single” “ Grouping” “ Worksharing” Tracking Number

7. Variation scenarios Copyright eCTDconsultancy B.V. Grouping and worksharing in eCTD Scenario Submission Mode No. of eCTD sequences Content management Submission Number req? Submission Type Same var type, same product Grouping One Combined cover letter, app form, QOS addendum etc No As per var type for all Different var type, same product Grouping One Combined cover letter, app form, QOS addendum etc No Highest type (longest review time) Type IA var , multiple products Grouping Multiple Documents included once per eCTD sequence Yes Type IA Multiple var types , multiple products Worksharing Multiple Documents included once per eCTD sequence Yes Highest type (longest review time)

8. Variation scenarios Challenging for eCTD Copyright eCTDconsultancy B.V. Grouping and worksharing in eCTD Scenario Submission Mode No. of eCTD sequences Content management Submission Number req? Submission Type Same var type, same product Grouping One Combined cover letter, app form, QOS addendum etc No As per var type for all Different var type, same product Grouping One Combined cover letter, app form, QOS addendum etc No Highest type (longest review time) Type IA var , multiple products Grouping Multiple Documents included once per eCTD sequence Yes Type IA Multiple var types , multiple products Worksharing Multiple Documents included once per eCTD sequence Yes Highest type (longest review time)

9. Impact on eCTD-specific business processes

16. Practical experience Lifecycle complexities Cover letter authorisation Timelines

24. Conclusions

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