Template for MAHs to provide their responses during type II variations or variation worksharing procedures  Template for MAHs response during type II variations (October 2025) [Track version]

The Addendum to the ICH S1B Guideline has reached Step 4 of the ICH process on 4 August 2022, being integrated with the original guideline and published as ICH S1B(R1) Testing for Carcinogenicity of Pharmaceuticals.

The Q/A document from the public webinar is now available.

Iopromide NO/H/xxxx/WS/049  Date of publication: 03/08/2022 NO/H/xxxx/WS/055 Date of publication 25/10/2022

Iomeprol Date of publication: 03/08/2022

Iodixanol NO/H/xxxx/WS/052 Date of publication: 03/08/2022 NO/H/xxxx/WS/056 ​​​​​​​Date of publication: 04/08/2022

The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.

The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration on the DADI website

The preparations for the external UAT are almost finalised 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). The link to the test system and details on how to send test submissions will be published as soon as they [...]

The recordings from both DADI public webinars held in January are now available here for the 18th and here for the 25th of January 2022.