eCTD Format Mandatory for EU National Procedures

Graphic design Online advertising

23 January 2019

BlueReg

After CP, DCP/MRP Procedures, and according to the eSubmissions Roadmap Timelines, eCTD format is now mandatory for all National Procedures in Europe

  • CP Procedure -> eCTD Mandatory from 2010
  • DCP / MRP Procedures -> eCTD Mandatory from January 2018
  • NP – all new applications -> eCTD Mandatory from July 2018
  • All Regulatory activities, including those for nationally registered products -> eCTD Mandatory from 1st January 2019

According to “Annex 2 to the HMA eSubmission Roadmap: Implementation of Mandatory use of eCTD Format for Regulatory Submission”:

  • It refers to all submissions types such as Variations, Renewals, PSURs, ASMF and so on…
  • The requirement is applicable for all Submissions from that date whatever the current format of the concerned dossier.
  • If no Baseline submission is officially required, it is recommended to consider a submission of a baseline for Module 3

In this context, and based on our strong experience within this domain, BlueReg can provide you with support regarding:

  • Publishing activities (more than 65 EU National Baselines & Switch dossiers published during 2018)
  • Strategic decisions & Planning (Prioritise your products and your submissions)
  • Documents Management / Formating
  • CMC Writing
  • Regulatory Support

References

BlueReg

Did you like this article? Share on social networks:

Associated News

BlueReg’s team will be pleased to meet you at RAPS Regulatory Convergence, booth 612A

BlueReg’s team will be pleased to meet you at RAPS Regulatory Convergence, booth 612A  ...

Learn more

Darwin – EMA – an invaluable resource to prepare for future healthcare crises and pandemics

Background:   In February 2022, the EMA initiated the establishment of the Coordination Centre for...

Learn more

BlueReg’s team will be pleased to meet you at BioFit Lille, on booth F10

Event location: Lille, France  Event date: Tuesday, December 4, 2018 to Wednesday, December 5, 2018 ...

Learn more


Line - Organism