The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.

EMA has announced the 3rd public system demo of 2022. In this system demo, EMA will demonstrate developments of DADI project and the PMS service as well as other ongoing projects. The system demo will take place on Wednesday 28th September 2022 at 09:00-12:30 (CET). This demo will be presented via live broadcast to ensure [...]

The ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reached Step 4 of the ICH Process on 27 September 2022.

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.