Medicines for human use The ICH E2D(R1) guideline on definitions and standards for the management and reporting of ICSRs has been published, together with training material containing practical examples of its application T1, T2, T3 Read more " April 10, 2026
Medicines for human use The EMA has published new guidance including a list of reference documents on the use of EV T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published a new version (February 23, 2026) of the EV support guide. T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published version 1.11 of the document ‘EV-EVWEB User manual’ T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published a new update of national contact details for reporting PV non-compliance (09 February 2026) T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published a new update (February 2, 2026) of the guide ‘GVP: Product or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk’ T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published a document on the procedure carried out at the Agency in the processing of personal data T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published a new module on considerations in the international transfer of data in ICSRs and SUSARs originating in the EU (EV-M8) within its online training on Pharmacovigilance and the management of Eudravigilance. T1, T2, T3 Read more " March 11, 2026
Medicines for human use The EMA has published a guide (30 January 2026) on registering in the ‘Union Product Database’ for UI and API users. T1, T2, T3 Read more " March 11, 2026
Medicines for human use A new revision (Rev.2) of the document ‘Questions and answers on the application of Regulation 2025/1466: Amendment to Regulation 520/2012 and conclusion of signal detection in EV Pilot by marketing authorisation holders’ has been published. T2, T3 Read more " February 10, 2026
Medicines for human use A new revision (January 22, 2026) of the ‘EVVet3 Production -release notes’ has been published. T1, T2, T3 Read more " February 10, 2026
Medicines for human use Chapter 5 of the ‘PMS-ISO standards for the IDMP in Europe’ has been published. T1, T2, T3 Read more " February 10, 2026
