Overview of comments on ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b

Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 January 2026, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026 to 15 January 2026

Minutes of the CVMP meeting 13-15 January 2026

Minutes of the CVMP meeting 2-4 December 2025

Human medicines European public assessment report (EPAR): Osqay, denosumab, Date of authorisation: 08/01/2026, Status: Authorised

Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Date of authorisation: 23/03/2018, Revision: 11, Status: Authorised

Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products

Guideline on quality aspects of mRNA vaccines for veterinary use

Opinion on medicine for use outside EU: Lenacapavir Gilead, lenacapavir sodium, HIV Infections,HIV-1, 24/07/2025 Positive opinion

ICH Q2(R2) Validation of analytical procedures - Scientific guideline