EU eCTD Specification 2.0 - Are You Prepared?

On September 1^st, implementation of the Module 1 EU Specification update from Version 1.4.1 to Version 2.0 becomes mandatory.

The period up to the September deadline will of course be a busy time for software vendors, who will need to incorporate the updates into their software; but Marketing Authorisation Holders will also need to plan carefully to ensure that their eCTDs comply with the new specifications.

How Will the Updates Affect Me?

I was recently in contact with someone who was unsure whether the changes to Module 1 would affect their company at all.

My response – they will.

Whether you submit eCTDs across all EU procedure types, or within the National procedure alone, the September deadline will affect you.

Changes to the content and structure of Module 1 are listed on the eSubmission website (http://esubmission.ema.europa.eu/eumodule1/index.htm) so I will not repeat those changes here at length.  Despite the fact that changes to the content and structure of Module 1 seem relatively minor, the important consideration is that updates to the EU DTD and Stylesheet mean that your eCTDs will be different to those you’re submitting now, whether or not (on the face of it) they look any different at all.

The bottom line is this – if you submit an eCTD with an EU Specification v1.4.1 Module 1 after September 1^st 2013, it will be rejected.

How Can I Prepare for the Deadline?

There are a number of ways you can prepare for September 1^st, to ensure that you don’t find yourself caught out by the deadline…

1.       Bring the Deadline Forward!

Implementation of EU Specification v2.0 must be before 1^st September, but can take place any time after 1^st July.

If over the coming weeks you don’t have much submission activity (as is normally the case over the Summer holiday period), and you’re able to do so, use this time to upgrade to EU v2.0 to ensure you aren’t caught out when submission activity picks up and the deadline looms...

Remember: Once you update to EU v2.0 you can NOT then submit v1.4.1 for any subsequent sequence. Failure to comply with this rule will mean that your later sequence will fail validation (see sections 3.4 and 3.5 of the Validation Criteria 5.0).

2.       Talk to your Software Vendor

It may well be the case that you can’t update when you like, but you should talk to your software vendors to find out when they plan to implement the updates, whether you can update within a certain timeframe, and whether the update will affect ongoing submission activity.

Submission software can vary a great deal, so you should find out exactly how the implementation will take place and how long it will take. Don’t get caught out at the last minute.

3.       Plan Your Workload

It sounds obvious, but given the potential for disruption to your submission activity, it might be a good idea to prioritise your workload to ensure that those submissions without important deadlines are left until the deadline has passed and the heat is off.

4.       Work out a Submission Strategy

For those submissions which simply can’t move, you should prepare a strategy to ensure that the potential for rework is kept to a minimum. For example, would it be possible to publish Modules 2 – 5 first and leave Module 1 until the end? This is a typical eCTD strategy anyway, however you wouldn’t want to prepare your Module 1 early only to find out that most of the work will need to be performed again.

Remember: The September update relates only to Module 1. Modules 2 – 5 remain unchanged.

There are of course other ways the deadline might affect the way you work, and other things you can do to prepare, so the above list is not exhaustive. However the lesson is this: plan ahead for all outcomes now, and ensure you aren’t bitten when the deadline arrives.