Making sense of the regulatory landscape in the UK and Europe

This year marks the 10-year anniversary since eCTD became mandatory for all submissions to the EMA for Centrally Authorised Products, meaning all these products have eCTDs hosted by the EMA. After the transition period on the 31st December 2020, the MHRA will not be able to access these eCTDs anymore, meaning new baseline sequences will need to be submitted to the MHRA via their dedicated portal (as CESP will no longer be usable for UK submissions). This adds an extra layer of complexity for pharmaceutical companies who wish to hold EU and UK licences after the transition period, especially when you add in that the UK could potentially have its own eCTD module 1 specification.

The maintenance of the eCTD in multiple regional territories is a constant and tiresome burden that the modern pharmaceutical company must carry and maintain. We know that to reduce the expense of managing compliant electronic submissions, you need a localised eCTD solution provider that can work to your timelines and maintain compliance, giving you permission to focus on the content of the submission rather than its format.

Here at Jenson R+, we understand that the need to build, view, validate and publish comes with its own set of challenges. As an early adopter of the eCTD format, we began creating eCTDs in 2006 using our own in-house solution; and as more third party software has come available over the years, we have supplemented our solution with these products to ensure we can service clients who come to us with complicated eCTD structures.

In fact, we have recently added to our software portfolio in our Nottingham office, markedly increasing our capacity for eCTD publishing. Combine this with our in-house technical experts and we have an all-encompassing submission service offering that can be tailored to your needs. As such, we can assist you in any of the following activities:

  1. Assessing submission strategy
  2. Preparing/troubleshooting the dossier modules
  3. Building the eCTD
  4. Publishing and validating
  5. Submission (via MHRA Submissions platform, EMA gateway and CESP)

Here at JensonR+, we will be continuing to monitor the situation in 2020 and beyond, so follow us on LinkedIn to receive any updates. If you would like to discuss how we can make the eCTD publishing and submission process work for you in the UK and EU, please do not hesitate to contact us at consultancy@jensongroup.com.

Ben Smith