The issues relating to preparations for the external UAT have been solved and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). Please note that internal testing is still ongoing, and it is recommended that external testers do not start [...]
The updated excel sheet listing all fields in the Variation and Medicinal Product has been published on the DADI website on the 23rd of May. The Conceptual Data Models for the human variation form FHIR message and the medicinal product in a variation FHIR message are now also available on the DADI website. The example [...]
The International Council for Harmonisation (ICH) met on the 21 – 25 May, in Athens, Greece, for the first time in a hybrid format, with both in-person and virtual participation across the meetings of seven Working Groups, the ICH Management Committee, the MedDRA Management Committee and the ICH Assembly.
Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details on the timeline leading to go-live and go-live scope are now available.
A free-text analysis report has been published on the ICH website, further to an analysis of the anonymised comments from the industry participating in the most recent implementation survey conducted in 2021.
Varilrix (live attenuated Varicella virus (OKA strain)) End of procedure: 15/03/2022 Date of publication: 31/05/2022
The Model-Informed Drug Development (MIDD) Discussion Group, which was established in January 2021, has provided as an output of its discussions, considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The ICH E8(R1) Guideline on General Considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
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.