Medicines for human use A new version (Rev. 5) of the question and answer document on signal management has been published, which, among other things, establishes the obligation to analyse Eudravigilance data in the detection of signals for all types of products, not just those on the pilot list. T2, T3 Read more " February 10, 2026
Medicines for human use A new version (21 January 2026) of the Product Management Service (PMS) Q&A document has been published with new information on the deadline for data enrichment. T1, T2, T3 Read more " February 10, 2026
Medicines for human use A new version (3.12) of the “IRIS for applicants” guidance document has been published. T2, T3 Read more " February 10, 2026
Medicines for human use A new version (1.7.2544) of the document ‘Union Product Database (UPD) release notes’ has been published. – CopyA new draft version of the user manual for the new XEVMPD interface has been published and will be available during the first quarter of 2026. The main changes are described in Annex I of this manual.A new version (1.7.2544) of the document ‘Union Product Database (UPD) release notes’ has been published. T1,T2, T3 Read more " January 27, 2026
Medicines for human use A new version (1.7.2544) of the document ‘Union Product Database (UPD) release notes’ has been published. T1,T2, T3 Read more " January 27, 2026
Medicines for human use A new version (Rev.2) of the form that TACs must complete for the notification of signals detected and validated with veterinary medicines has been published. T1,T2, T3 Read more " January 27, 2026
Medicines for human use A new version (Rev.13) of the document ‘Veterinary Union Pharmacovigilance Database-Best Practice Guide’ has been published. T1,T2, T3 Read more " January 27, 2026
Medicines for human use The EMA has published an update (Rev.4) to the list of abbreviations used in its Scientific Committees and in documents published by the Committee for Medicinal Products for Human Use, as well as those derived from its regulatory activities. T1,T2, T3 Read more " January 27, 2026
Medicines for human use The EMA has begun sending monthly reports to pharmacovigilance managers on compliance with deadlines for reporting ICSRs to Eudravigilance and has published a question and answer document on this process. T1,T2, T3 Read more " January 27, 2026
Medicines for human use A new document has been published on questions and answers from the Union Product Database. T1,T2, T3 Read more " January 27, 2026
Medicinal products for veterinary use A new version of the document ‘Registration guide for UI and API users’ has been published (1 December 2025) T1,T2, T3 Read more " January 27, 2026
Medical devices The EUDAMED four first modules (Actor registration, UDI/Devices registration, Notifies Bodies & Certificates and Market Surveillance) will be mandatory to use as from 28 May 2026 T1, T2, T3 Read more " December 10, 2025