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
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 Se ha publicado una nueva versión (v.3.6) del capítulo 3 ‘Process for the electronic submission of medicinal product information’ del PMS-implementation of ISO standards for the IDMP in Europe’ T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new version (v. 3.14) of the “IRIS Guide for Applicants” and version 2.19 of the “IRIS Guide to Registration and RPIs” have been published. T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new update (Rev. 1) of the document “Questions and answers on the periodic safety update report single-assessment (PSUSA)” has been published T2, T3 Read more " June 10, 2026
Medicines for human use A new update (Rev. 4) of the document “Explanatory note to GVP Module VII” has been published T2, T3 Read more " June 10, 2026
Medicines for human use A new version (v.160) of the ‘List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)’ has been published T2, T3 Read more " June 10, 2026
Medicines for human use The CMDh has published a new version (Rev. 8) of the document ‘CMDh Guidance on the Informal Work-Sharing Procedure for Follow-up of PSUSA for NAPs’ T2, T3 Read more " May 8, 2026