The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023.

We are pleased to inform you that the next version of the Common Repository introducing the Basic Authentication is going live on the 14th of March 2023.

The Variation FHIR mapping and the conceptual data models have been updated and are now available here.

The eAF and PMS teams are pleased to announce that an eAF-PMS FAQs Document is now available here. This document contains Frequently Asked Questions on eAF and PMS and will be updated regularly.

Due to essential maintenance, Common Repository and eSubmission Logs, will be unavailable on Tuesday 28 February 2023 between 18:00 and 20:00 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk

CMDh letter to MAHs of tenofovir disoproxil-containing medicinal products (February 2023)

2022 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

Report from the meeting held on 23-25 May 2023 Report from the meeting held on 24-25 April 2023 Report from the meeting held on 28-30 March 2023 Report from the meeting held on 21-22 February 2023 Report from the meeting held on 24-26 January 2023

A Step 2 Informational Presentation has been developed by the M13 Expert Working Group, in follow up to the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of the ICH Process in December 2022.

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022.