Module 1 2021

25/06/2021

What’s Next?

The Organisation for Professionals in Regulatory Affairs

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What’s next? (1)

• The ICH have been working on eCTD v4.0 for over 10 years • The development is a collaboration with ISO and HL7 which should lead to a technical standard that is also an internationally recognised standard • This offers many more possibilities to see the eCTD adopted by agencies • eCTD v4.0 is intended to address a number of business scenarios where the current eCTD specification (v3.2.2) struggles ─ Particularly some of the more complex EU procedures for Grouping and Worksharing in the MRP/DCP ─ Also more flexibility in extending the standard to other “non-CTD” submission structures • The initial signoff was in late 2015 with implementation activities planned to begin in 2020 and beyond…

The Organisation for Professionals in Regulatory Affairs

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