An updated version 1.26.0.0 of the human variation eAFs is now available here. A single change has been implemented to emphasize the mandatory use of OMS for centralised procedure by updating the Declaration label in the Proposed section. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is [...]
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.
Iodixanol NO/H/xxxx/WS/052 Date of publication: 03/08/2022 NO/H/xxxx/WS/056 Date of publication: 04/08/2022
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