The ICH E11A draft Guideline reaches Step 2 of the ICH process
The ICH process on 4 April 2022 and now enters the public consultation period.
The ICH Revision of Q2(R2) draft Guideline reaches Step 2 of the ICH process
The ICH Revision of Q2(R2) draft Guideline on Validation of Analytical Procedures reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.
The ICH Q14 draft Guideline reaches Step 2 of the ICH process
The ICH Q14 draft Guideline on Analytical Procedure Development reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.
Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v1.26.0.0 has been fixed
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 [...]
DADI Project Update – Updated timeline for the release of Human variations forms
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…
2021 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
Veterinary Medicinal Products Regulation (Regulation (EU 2019/6) enters into force – updated eSubmission systems/forms now available for mandatory use
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) Training Material now available on the ICH website
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 of the eAF v1.26.0.0 now available
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 [...]
Digital Application Dataset Integration (DADI) Network Project Webinar 18/01/2022 – Live broadcast available
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 [...]