Longer lifecycles call for better quality – changing your eCTD publisher might be the solution

Medfiles eCTD services

Electronic common technical documents, better known as eCTDs, came to the regulatory world more than ten years ago. In the past, the thought of changing the eCTD publishing tool was unthinkable, as the guidelines and specifications left little room for diversity and the systems did not work that well together. Also, there were only few vendors with proper tools.

Today, there are several eCTD publishing tool providers in the market, and their products vary in many aspects, such as in pricing, functionalities and sometimes even in the quality of published sequences. However, even with the increased competition, the pricing has stayed quite high. For smaller companies, the annual costs might be significant, compared to the actual need for the tool. In such cases, the best option might be to outsource your eCTD publishing tasks to an external eCTD publishing service provider to save you valuable time and money.

As the lifecycles of eCTDs get longer, making their technical quality all the more important, changing the eCTD publisher might come into question. The change can have many benefits, from cutting costs to the better quality of the published eCTDs.

The actual change is not as demanding as one might think, as the current lifecycle can be continued with the new tool or with the new publisher from the next sequence, without any extra work for the authorities. At this point, technical baseline creation is not necessary, but on the other hand, the change provides a perfect opportunity to restructure the eCTD in case there is need for it.

We at Medfiles use an eCTD publishing tool that is widely used around the world by different authorities. With more than ten years of eCTD publishing experience, Medfiles can offer you experienced support for all your eCTD publishing needs, including working as your dedicated eCTD publishing service provider.

METHOD OF FILLING IN ELECTRONIC APPLICATION FORMS (EAF) CHANGING

A new way of filling in electronic application forms (eAFs) for variations for human medicinal products in the EU is coming. The DADI project, as it was called earlier, is getting closer to gathering all products for all procedures to the product lifecycle management (PLM) portal.

Centrally authorised human medicinal products have been available in the portal for variation eAFs already from early November 2022. Nationally authorised products for human use are expected to become available in the portal for variation eAF use by Q1/2024. This starts a 6-month transition period during which applicants can use the old eAF and new web-based eAF in parallel before it becomes mandatory.

The new portal means new user roles. There are three roles in the PLM portal for industry users: eAF Applicant Coordinator, eAF Applicant Manager and eAF Applicant Contributor. Companies can handle the eAF management with the roles in multiple ways. Most of the eAF tasks can be easily delegated, but that requires the company to assess what level of access they want to share with CROs. We at Medfiles can help you with this.

Please keep in mind that the other types of eAFs, initial marketing authorisation application forms, renewal application forms and veterinary application forms, are still out of scope of the new web-based eAF and need to be filled in as before.

If you need support with eCTDs or with the new web-based electronic application form, contact us!

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