The ICH E8(R1) Introductory Training Presentation now available on the ICH website
The ICH E8(R1) Guideline on General Considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
Clarification on Variations Not Requiring Assessment (VNRA) availability in the Common Repository (vet domain)
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.
ICH Statement on the situation in Ukraine
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 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.