Key takeaways from the eCTD 4.0 EU technical pilot

EMA has also updated the documentation for applicants, the validation criteria for eCTD 4.0 submissions, and EU eCTD 4.0 controlled vocabularies. The criteria are important to show industry what EMA will be checking when they receive a submission to determine whether or not it is technically valid. It should be noted that the current validation criteria are not yet final, and further updates will need to be released.

The controlled vocabularies (CVs) initially released by EMA were incomplete but updated shortly after the missing elements had been detected. This also provided applicants with some insight on EMA’s process of updating CVs and how long it takes vendors to implement them.

EMA has yet to update the draft implementation package from October 2024. However, with experience gained from the second phase of the pilot, the agency is likely to issue a further update, and perhaps even the final version, within the next few months. 

For most tool vendors, it seems everything is in place to enable their clients to build eCTD 4.0 applications for Europe, though the pilot submissions have revealed some minor glitches in some tools that still need to be fixed.

The progress of the pilot makes it more likely that we might see the first real eCTD 4.0 applications being submitted in Europe before the end of this year, and the planned mandatory use of eCTD 4.0 for Centralised Procedure Applications in 2027 is an achievable target. 

With the US Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), EMA, and most likely some other agencies being able to receive and assess applications in the new format, the onus will be on global applicants to increase their efforts to implement eCTD 4.0 as their preferred submission format and  exploit the synergies of using the same format in their major markets.