Added in May 2023 22 May NEW - 23-25 May agenda 3 May UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected” UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines UPDATE [...]
Levonorgestrel intra-uterine devices (LNG-IUDs) Date of publication: 03/05/2023
Due to essential maintenance, PSUR will be unavailable on Tuesday 11 April 2023 between 18:00 and 20:30 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk
Ifosfamide Date of publication: 12/04/2023
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.