Assessing the value of eCTD baseline submissions

What is an eCTD baseline?

An Electronic Common Technical Document (eCTD) baseline is used to convert an existing marketing application dossier from its current format to eCTD, allowing the applicant to submit it to the regulator electronically.

This captures the currently approved state dossier and converts it to eCTD format, where it can be used as a base for future electronic lifecycle management.

Typically, module 3 (m3) documents are included in the baseline. These are the most commonly life-cycled/revised credentials within the dossier.

As a rule, baseline submissions happen independently of a regulatory submission.

What is required in a baseline submission?

All baseline submissions must include a declaration stating that the content of the documents has not been changed and that no further or new content is being submitted.

In some instances, and health authority permitting, applicants may combine the transition to eCTD with a planned regulatory activity.

Here, all the documents must be submitted electronically in eCTD format. Documents which are related to the submission should be clearly highlighted, as should those which are already approved or unchanged and which are being submitted to support the transition to eCTD.

What modules should be included in a baseline submission?

The timing of the baseline and any staggered approach should always consider the requirements and expectations of the relevant regulatory agency.

As part of this, regional health authority requirements should be consulted to confirm the region-specific requirements and the best approach to take when planning to baseline a CTD dossier.

Examples of the current requirements in terms of which modules are required for baseline submissions are as follows:

UK: Full m2, m3, m4 and m5

Australia: Full m2, m3, m4 and m5

GCC regions (Bahrain, Oman, Qatar, Saudi Arabia and UAE): m3

Jordan: m3

South Africa: m2.3 and m3

US: Full m2, m3, m4 and m5

CA: Full m2, m3, m4 and m5

When is a baseline submitted?

Ideally, a baseline should be submitted at the start of the drug product application process, meaning that the newly approved dossier would start at eCTD sequence 0000.

However, for many regions, eCTD was not mandatory at the time of application. In these cases, the baseline submission can be made at any point during the lifecycle.

The baseline must include the relevant sections of the currently approved dossier with this stage of the process being arbitrarily assigned, regardless of how many previous post-approval dossier updates have occurred.

It is important that the applicant considers the best timing for the submission of the baseline.

As baselines can take considerable time to prepare, applicants are advised to choose a time when there aren’t likely to be any foreseen upcoming regulatory submissions affecting the dossier.

It may also be possible to submit the baseline by module - for example, m3 is baselined initially, followed by m4 and m5 at a later stage.

Research and results

There are several advantages to submitting an eCTD baseline.

Firstly, because the baseline includes all the current approved documents, the regulator has all the available data, meaning that the applicant will not need to submit dossier fragments purely for reference purposes in any future submissions.

Instead, the applicant only needs to make a reference to the related section of the dossier and provide a link to that section within the eCTD.

Secondly, the lifecycle management of the dossier is more efficient in terms of tracking revisions and history of the dossier for future updates to the application.

For those preparing the dossier, generating submissions without an existing baseline can be cumbersome in terms of producing the submission package.

Is submitting a baseline the best option?

As outlined above, baseline submissions have benefits in terms of dossier lifecycle management and, in some cases, eCTD is a mandatory requirement of the application process.

However, some factors should always be considered before pursuing this route.

The initial costs of generating an eCTD baseline must be kept in mind, along with the logistics of timing a submission to avoid conflicts with ongoing regulatory submissions.

Weighing up these elements prior to an application will prove invaluable in helping to determine if preparing and submitting an eCTD baseline is justified and the optimum approach for the future of the product's lifecycle.

eCTD baseline submissions are just one of the many services and solutions provided by G&L Healthcare Solutions. Find out more at: www.gandlhealth.com/what-we-do

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