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eSubmission Roadmap (reflecting final version 1.0 dated 140721)

Ongoing/optional Mandatory. eSubmission Roadmap (reflecting final version 1.0 dated 140721). draft eSub Roadmap. NCA & industry survey. eSub Roadmap Adoption. Use of eCTD v.4. All submissions in CP in eCTD (human). All submissions in CP, DCP and MRP in eCTD.

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eSubmission Roadmap (reflecting final version 1.0 dated 140721)

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  1. Ongoing/optional Mandatory eSubmission Roadmap(reflecting final version 1.0 dated 140721) draft eSub Roadmap NCA & industry survey eSub Roadmap Adoption Use of eCTD v.4 All submissions in CP in eCTD (human) All submissions in CP, DCP and MRP in eCTD New MAA in DCP and MRP in eCTD Use of NeeS and eCTD in DCP and MRP (human) New MAA in DCP in eCTD MRP All other MRP submissions Use of VNeeS in CP, DCP and MRP (vet) New MAA in CP and DCP in VNeeS All submissions in CP, DCP and MRP in VNeeS All other CP submissions and all MRP submissions CESP (human & vet) Single submission portal - combined CESP/Gateway Fully functional single submission portal for all submissions (human & vet) eGateway (CP) (human and vet) eGateway (CP, human) (Mandatory for CP-human, optional for other procedures) Use of eAF in CP eAF in all procedures in MRP/DCP NCA use of Common Repository for CP submissions (human) NCA use of Common Repository for all CP submissions (human) 2013 2014 2015 2016 2017 2018 eSubmission Roadmap Timelines

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