The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process on 3 April 2023.
Following the launch of the Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) Portal, we appreciated many users have accessed the PLM Portal to work on variation applications using the new web-form.
The ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process in January 2023.
We are pleased to inform you that the next version of the Common Repository introducing the Basic Authentication is going live on the 20th of March 2023 (originally planned for the 14th of March).
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)