The updated versions 1.26.0.0 eAFs (Veterinary MAA and variation, human variation) were published on the eAF website on 20th of January 2022. A technical issue has been identified which means that these latest versions were replaced by earlier versions (at some point around 5th of February). The issue has been now fixed and the latest [...]
Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available.
2021 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
The use of the updated version of 1.26.0.0 eAFs is now mandatory for all new veterinary variations and marketing authorisation applications. Please note that there is no transitional period and the v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.
The ICH E9(R1) EWG finalised the development of the Training Material for Estimands and Sensitivity Analysis in Clinical Trials. Further information can be found on the ICH E9(R1) EWG webpage, including the Training Material which is also available to download.
Updated versions 1.26.0.0 eAFs are now available on the eAF website. An updated human variation form is ready for immediate use. The change implemented in this version is a minor business rule change only and it will not affect most users. The use of the v1.26.0.0 is mandatory since 1st January 2022 and the users [...]
In a previous news published on 10 December 2021 EMA announced the upcoming webinar ”Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms” on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project team is pleased to [...]
'Blue-box' requirements (May 2023) [Track version]
User Guide for the electronic Application Form for a Marketing Authorisation (September 2023) [Track Version]
EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only (December 2025) [Track version]