A Step 2 Informational Presentation has been developed by the M12 Expert Working Group, in follow up to the ICH M12 draft Guideline on Drug Interaction Studies reaching Step 2b of the ICH Process in May 2022.
In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite Applicants to participate in the UAT of the Digital Application Dataset Integration (DADI) Network project.
The eSubmission Web Client portal has now been upgraded to Axway Syncplicity portal. Please access the new Web Client to send submissions to the EMA here.
Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.
As previously announced, the EMA is in the process of upgrading our current Axway Gateway solution. Please note that migration of all users in the Production System will be done this weekend, starting from Friday, 8 July 2022, at 17:00 CEST until Sunday, 10 July 2022, at 18:00 CEST. Should this need to be postponed, [...]
The ICH Q3D(R2) Guideline for Elemental Impurities reached Step 4 of the ICH Process in April 2022. A Step 4 Introductory Training Presentation has also been developed by the Q3D(R2) Maintenance EWG and is now available on the Q3D(R2) webpage with the Step 4 ICH Q3D(R2) Guideline.
The issues relating to preparations for the external UAT have been solved and all eSubmission Web Client XCOMP users are now invited to start user acceptance testing (XCOMP environment). Please refer to the Guidance on how to submit using Syncplicity Web Client.
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.