Tag Archives: safety signal managment

Prolongation of the pilot on signal detection by MAHs in EudraVigilance

The European Medicines Agency (EMA), with the agreement of the European Commission, have announced that the pilot phase of monitoring data in EudraVigilance for safety signals will be extended. The pilot was initially planned to last for one year but has been extended beyond February 2019.

The pilot started on 22 February 2018 focusing on active substances included in ‘List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders’. Until further notice by the EMA, MAHs with an active substance or combination included on the list should continue performing signal detection in EudraVigilance for these substances.

The EMA plans to survey the MAHs involved in the pilot phase on their experience; they will use the findings to prepare a report by the end of September 2019.

A decision on the next phase of implementation, including the products to be included and the date of coming into effect, will be communicated to stakeholders by the EMA by the end of December 2019.

Regulatory guidance on the detection and reporting of signals from EudraVigilance is provided in Good Vigilance Practice (GVP) Module IX on Signal Management. Purple Vigilance Limited can assist with signal detection and management activities, please contact us for more information.