EMA announced that step 2 of their eCTD v4.0 Technical Pilot, for Centrally Authorised Products (CAP), has launched. Applicants are invited to test eCTD 4.0 submissions. From 15 July – 15 September, the eCTD v4.0 Technical Pilot will focus on four scenarios, including an initial MAA, validation responses, and post-authorisation activities. Step 3 is planned for late Q3 2025, expanding the current scenarios to test forward compatibility, including lifecycle management and submission grouping. We at EXTEDO are proud to be the EMA’s chosen provider of their eCTD v4 modern web-based viewing solution, EURSnext, and are happy to see how they benefit from it.
“With the launch of the second step, EMA is one of the first agencies to progress towards forward compatibility”, explains Anjana Pindoria-Rettenberger, Director of Product Strategy, “After almost 20 years of supporting EMA in the reviewing process of eCTD v3, we are now happy to move forward with them to the next generation of eCTD. We are looking forward to accompanying the EMA and other agencies on this important journey.”
Interested MAHs who like to join the second step of EMA’s eCTD v4 pilot are invited to provide details of products, scenarios, and - very importantly- the name of the software partner, until 15 July by email to eCTD4consultation@ema.europa.eu. Participation is very limited and based on the readiness and compliance with the scenarios and focus described by the EMA:
https://esubmission.ema.europa.eu/eCTD%20NMV/eCTD.html