CHMP PROM minutes for the meeting on 30 October 2023

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Overview of comments received on ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

EMA business hours over holiday period

Consolidated 3-year work plan for the Emergency Task Force (ETF)

Goodbye 2023: when optimism came back

Request a change of the applicant for an ongoing marketing authorisation application

List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)

Biologicals: finished product