AGNES CWIENCZEK
Director of Product Management at Amplexor, an ArisGlobal company, Croatia

Abstract

It would be easy to conclude that the implementation of IDMP standards for future regulatory exchanges is the be-all and end-all of pharma regulatory process modernisation and the only driver of current IT and data-based projects. Yet the significantly updated eCTD 4.0 standard, whose details have now been published, is at least just as important, affecting the way Life Sciences companies submit dossiers internationally. Amplexor’s Agnes Cwienczek summarises the key requirements and the preparations now needed.

By as soon as 2026, Regulatory bodies around the world will start to require compliance with the more recently finalised and published eCTD 4.0 dossier submissions standard(s) (details can be found on the ICH website (1)). Up to then, compliance is largely voluntary across international markets, but between 2026 and 2029, the new requirements will start to be enforced. Unless they are properly geared up for the new requirements before then, pharma companies risk not being able to get new drugs authorised, or changes to existing drugs approved, in some major markets internationally.

Despite this very real time pressure, there is still such a great focus on IDMP and associated data as the be-all and end-all of current shifts in regulatory requirements that the urgency around changes to dossier preparation, publishing and submission is often being missed. This is a huge oversight, which could leave companies seriously unstuck.

The electronic Common Technical Document (eCTD), which allows for the electronic submission of the Common Technical Document (CTD) from pharma applicant to regulator, devised by the International Council for Harmo ...