Since 2009, the European Medicines Agency introduced eCTD as the mandatory format for the centralised procedures, the use of eCTD has increased to the point that all regulatory submissions in Europe will have to be performed in the eCTD format.
Why is eCTD preferred to NeeS or paper?
eCTD has many advantages over NeeS or paper. Due to ever-evolving regulations and trends, it is extremely important for the companies to have a full traceability of all the documents. It is important for Agencies as well.
Thanks to the eCTD format, it is easy to identify the latest version of a document that was sent to the Agency. In addition, it can be traced which documents have been and which haven’t yet been approved. This is known as a dossier lifecycle, which doesn’t exist in NeeS or paper.
Having all the information related to a dossier in one single place is just perfect, a music to your ears.
OK, eCTD is becoming mandatory, but… do I have to start using this format now?
The agencies are very clear on this: “We strongly urge applicants to make all their submissions in eCTD format” (Harmonised Technical Guidance for eCTD Submissions in the EU).
At this point, Industry might face a significant problem. Starting in January 2019, ALL submissions European submissions will have to beperformed in eCTD format. You have to consider how many dossiers at your organisation are affected and have a plan in place to ensure you are compliant by the time eCTD becomes mandatory.
What happens if I don’t have my dossier in eCTD format? How should my first submission be performed?
There is no problem, you have two options at the time of preparing the first submission in eCTD:
- The easy option: just compile the documents needed for a specific variation/submission in the eCTD format and send the first eCTD sequence (0000) with this data to the agency.
- The smart option: your first sequence (0000) should be a baseline or a consolidated sequence of your dossier. Based on the baseline, you start the Life Cycle Management of your dossier by submitting your subsequent submissions (0001 and further) in eCTD format.
Is it mandatory to prepare a baseline of my dossier?
It is not strictly mandatory, but it is highly recommended by the agencies to the point that, at any time, they can request a consolidated sequence (baseline) to the holder.
In Asphalion, we have been working with the eCTD format for over 10 years. We are experts in this type of submissions. Based on our extensive experience, we highly recommend a compilation of a baseline when converting your dossiers from NeeS to eCTD.
What are the advantages of preparing a baseline?
A baseline includes the latest valid version of all the approved documents of a dossier. From that sequence on, the lifecycle of the documents can continue (replace, delete, add as new). Without a baseline, a submission where a document has to be updated and this document is not included in a baseline sequence, makes it impossible to trace.
Consolidating sequences (baselines) are free of charge. The only requirement is a statement in the cover letter that no change in the content has been made.
When should I prepare a baseline?
In order to plan the baseline, it is important to know the status of the dossier and the pending evaluations of variations is required.
As indicated in the guidelines, in order to submit a consolidated sequences (=baselines), ideally, there should be no on-going regulatory activity. Nevertheless, there are always exceptions. (If you are not sure, please contact us and we would be more than happy to discuss the status of your dossier).
What should be the content of a baseline?
In relation to the content of the baseline, it depends on the dossier and the accessibility of the documentation. Ideally, the baseline sequence should contain the whole dossier (m1 to m5). However, the agencies are aware that this might not be possible and therefore, they recommend to at least consolidate the documentation related to quality (m2-m3). A decision on the content should also take into account the future plans of a dossier (i.e. only maintenance activities are expected, or a Repeat Use Procedure is planned).
What do I need to create a dossier in eCTD?
Firstly, and most importantly, you need to have a software that allows the creation of xml files in order to navigate through the dossier. It is also really important to understand what the document lifecycle actually means and how it works.
In Asphalion, we have wide experience in the installation, validation and training of a specific software for eCTD compilation. Depending on your internal resources, budget and the volume of sequences that need to be published, it might be worth outsourcing the publishing activities, as this would prove to be more cost-effective.
Many of our clients have seen the true value of baselines. Our eSubmission team is already collaborating with a large number of pharmaceutical companies on preparing their baselines as well as identifying the documentation needed to be presented in the baseline, based on the NeeS sequences already presented.
Furthermore, we advise our clients on the conversion from NeeS to eCTD, taking into account that it is possible to combine several NeeS dossiers into one single eCTD dossier.
Starting with the right foot in the eCTD world is much more convenient, if you have consolidated dossiers.
Any help you might need with the preparation of baselines, understanding the world of eCTD or choosing the right software, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.
Do not hesitate to contact us at ectd@asphalion.com for further questions and support.
