Medicines for human use A new version (7 August 2026) of the Product Management Service (PMS) FAQs has been published. T1, T2, T3 Read more " September 11, 2026
Medicines for human use A new version (3.7) of ‘Chapter 3: Process for the electronic submission of medicinal product information’ of the PMS – Implementation of ISO IDMP in Europe has been published. T1, T2, T3 Read more " September 11, 2026
Medicines for human use A new version (v. 2.5) of Chapter 2, ‘Data elements for the electronic submission of information on medicinal products for human use’, of the PMS: ‘Implementation of the ISO IDMP standard in Europe’, has been published. T1, T2, T3 Read more " September 11, 2026
Medicines for human use A guide on the new module in CTIS concerning annual safety reports, aimed at sponsors, has been published T2, T3 Read more " August 13, 2026
Medicines for human use A MedDRA document on mediation errors in version 29.0 has been published T1, T2, T3 Read more " August 10, 2026
Medicines for human use A new version (v.162) of the document ‘List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)’ has been published. T2, T3 Read more " August 7, 2026
Medicines for human use A new version (6 July 2026) of the ‘User manual for the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)’ has been published T1, T2, T3 Read more " August 7, 2026
Medicines for human use A new version (2 July 2026) of the guidance on coding indications in the XEVMPD has been published. T1, T2, T3 Read more " August 7, 2026
Medical devices A new version (June 2026) of the “MDCG Position Paper: Management of the Summary of Safety and Performance in Eudamed after Mandatory Use” has been published. T1, T2, T3 Read more " July 10, 2026
Medical devices Version 7.3.1 of the manufacturer’s adverse event reporting form. T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new version (v. 6.3) of the “Sponsor Handbook—Clinical Trial Information System (CTIS) Guidance on Using the Sponsor’s Workspace” has been published. T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new version (v. 1.10) of Chapter 7, “Submission of Other Post-Authorization Data,” of the “Vet EU IG on Veterinary Medicines Product Data in the Union Product Database” has been published. T1, T2, T3 Read more " July 10, 2026
