Roadmaps

Mandatory use of eCTD format in EU procedures

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018
November 10, 2017
Do you have a medicinal product registered in Europe? Please be aware that eCTD will become the mandatory standard for submission for maintenance activities!
The eCTD roadmap has been updated to focus on the mandatory use of eCTD. These are the dates for the different procedures:
  •  January 2018: All MRP submissions (human)
  •  July 2018: new MAA in NP (human)
  •  January 2019: All submissions (human) in CP, DCP, MRP and NP
 
Asphalion has over 10 years of experience with eSubmissions and support all EU procedure types (CP, MRP/DCP and NP).
If you need any support for eCTD publishing and/or baseline preparation, contact us at info@asphalion.com 
 
For more information: http://bit.ly/2zqqHb3
 
 
 
 

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