EMA'S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation

By Karl-Heinz Loebel, Director & Principal Consultant Of Regulatory Operations, Cencora PharmaLex

The European Medicines Agency (EMA) is getting ready to implement the eCTD 4.0 standard in the pharmaceutical industry. In this article, we will explore the key developments, including the recently released draft EU eCTD 4.0 Implementation Guide and the upcoming pilot programs.

The new guide, together with the ICH eCTD 4.0 V1.5 Implementation Guide, explains the structure and functionalities of eCTD 4.0. The guide primarily focuses on Centralized Procedure (CP) submissions to EMA, with a plan to roll it out for national agencies later. To ensure a smooth transition, EMA conducted a workshop in March to address potential gaps and gather industry feedback. A key theme that emerged is the need for clarity on document replacement, reuse, and the use of dedicated eCTD 4.0 review tools.

This article outlines the planned eCTD 4.0 implementation timeline, including voluntary technical and business pilot programs that are expected to begin this year. Industry participants are encouraged to familiarize themselves with the new standard and consider participating in the pilot programs.