eSubmission Roadmap (reflecting final version 1.0 dated 140721)

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