Variations Not Requiring Assessment (VNRAs) are procedures only dealt with within the Union Product Database (UPD), without involvement of the rapporteurs. However, to continue to have a complete overview of a product life cycle including all post-authorisation procedures, VNRAs for Centrally Authorised Products will also be available in the Common repository, for reference only.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together leading regulatory authorities and pharmaceutical industry organisations to harmonise scientific and technical standards worldwide to ensure development and availability of safe, effective, and high-quality medicines.
The ICH process on 4 April 2022 and now enters the public consultation period.
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 on Analytical Procedure Development reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.
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.