How To In-Licence An eCTD Dossier

We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier.

When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully.  For instance, the eCTD version specific information and tool capability is crucial to import from one system to another.  Try to ensure the version number of the DTD/specification is equal to or lower than the software you will be using in-house or else you may need to upgrade software when it comes time to submissions which may lead to unplanned extra costs.

Editor’s Note: This article was originally written in 2016.  Eileen Ryan, Regulatory Publishing Manager at Acorn Regulatory, has updated the article to consider changes that have come about since it was first written.

This article requires the reader to answer many questions.  Planning to in-licence an eCTD dossier can be a complicated issue.  Our experts are available to help, if required.

1. Valid submission according to EU validation criteria

The first factor to consider when reviewing an eCTD dossier is technical validation.  Before importing the dossier, ensure successful technical validation has been run on all sequences.

Look to see the date of when this acquired dossier was started within eCTD.  Older dossier structures may not be valid as per new validation criteria.  It is important to consider this possibility when acquiring a licence.

Re-run validation on any invalid sequences that were created prior to the eCTD current validation criteria set with earlier relevant versions available.  This will help you in determining if any xml structure errors exist.  Xml structural errors may cause issues when importing sequences into in-house eCTD software.  Therefore, depending on the structural issues at hand a technical custom import may need to be considered.

2. Timing of moving from non-electronic format to eCTD

Firstly, ask the question: when did this dossier start in eCTD?

Was it started from the New MAA application or perhaps it was it started later post authorisation.  If the dossier was transferred to eCTD post authorisation, then check if a baseline was ever submitted for this dossier.  A baseline submission is recommended at the time of changing to eCTD. (Technical eCTD Guidance v4.0) It would be a compiled submission containing the approved licence dossier information that was submitted to the authorities prior to changing to eCTD.

3. Has the Lifecycle Management Been Maintained?

Confirm that lifecycle management has been maintained.  Request to see the current view.  Look at the current view to determine what kind of a model is used? (i.e. single or comprehensive model)

Is any work required to correct the existing lifecycle?

Take notes of structure already in place.  For instance, are the strengths combined or separated and are there node extensions or STF’s visible?

4. Granularity

What kind of granularity has been done?  Does it conform to the ICH granularity set out in the guidance?  Are there any discrepancies to be seen regarding drug substance/ drug product sections of the dossier?  Are there any structural issues that will prevent this licence from being incorporated into already existing internal procedures/processes for submitting future sequences?

It is always best to consider these factors during negotiations so any issues can be discussed by both parties.

The Acorn Regulatory eCTD specialists can help you with any of your eCTD or electronic publishing queries.  Talk to us today by calling 00353 52 61 76 706 or complete the details below and we will get back to you.

We’ll be glad to help.

Further Reading from Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

Much has been written about orphan drugs in recent times.  These products, developed specifically to treat a rare disease, have become more common in the marketplace.  At the time of writing (May 2020), there are almost 770 orphan drugs commercially available and more than 5600 orphan designated drugs in the biopharmaceutical pipeline.

As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability.  We look at some facts about orphan designation that companies considering entering the sector should be aware of.

Read more about orphan drugs here.

Medicinal Product Labelling: What You Need To Know

Medicinal products are no exception and must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet providing information enabling the safe and effective use of the medicinal product. In fact, medicinal products are legally required to have certain information on the labels and package leaflets as defined in Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended).

Read more about medicinal product labelling here.

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

  1. Companies that maintain control of electronic publishing at the corporate and head office level
  2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
  3. Companies that have outsourced eCTD entirely

In this article, we will look at the benefits and the limitations presented by the three options presented above.

Find out more about outsourcing eCTD here.


About the Author:
Eileen Ryan
Regulatory Publishing Manager
Eileen Ryan is the Regulatory Publishing Manager at Acorn Regulatory. In her current role she contributes to the strategic planning/preparation of regulatory submissions in collaboration with other departmental representatives and manages publishing team to ensure the successful publishing of high quality, compliant submissions in the relevant eCTD/NeeS formats to the health authorities. You can read more articles by Eileen Ryan by clicking the link below
Other articles by Eileen Ryan