eCTD Harmonisation

January 2019 deadline approaching.

eCTD format to be used for ALL regulatory activities in National Procedures by 01 January 2019. This means that with under a year to go the last stage in the HMA eSubmissions Roadmap will be in place.

HMA eSubmissions Roadmap time line:
  • 1st July 2015 – Use of eCTD for new MAA in Decentralised Procedures (DCP)
  • 1st January 2017 – Use of eCTD for new MAA in Mutual Recognition Procedures (MRP)
  • 1st January 2018 – Use of eCTD for ALL regulatory activities in European procedures (DCP/MRP)
  • 1st July 2018 – Use of eCTD for new MAA in National Procedures
  • 1st January 2019 – Use of eCTD for ALL regulatory activities in National Procedures

This step has been added to the updated version of the eSubmission Roadmap to strive for a harmonised approached within the EU and in consultation with all National Competent Authorities (NCAs).

Although eCTD submission requirements in the EU are becoming more harmonised, the format will become compulsory in January 2019. There are still market differences which MA Holders must adhere to under the National Procedure.

All submission types for a dossier, such as variations, renewals, PSURs, ASMFs, are required to comply with the eSubmissions criteria from January 2019 whatever the current format of the dossier.

How can Woodley BioReg help with eCTD publishing?

Woodley BioReg can assist with all aspects of CTD submissions and recognise that the preparation of files in individual PDF can be a long and tedious process, requiring a high degree of attention to detail.  One of the most common reasons for the rejection or delay in the assessment of a file is incorrect or illegible PDF conversion. Woodley BioReg’s conversion process ensures the accurate and efficient creation of eCTD files (for MAAs, INDs, ANAs, etc.) and the management of electronic submissions.

To find out how Woodley BioReg can help you comply with eCTD harmonisation please call on +44 (0)1484 43 43 43 or email with your questions.