‘Signal Management Pilot’ announced by EMA

On 23rd January 2018 the European Medicines Agency (EMA) announced the release of the, ‘ad hoc’ reference period electronic Reaction Monitoring Report (eRMR), in the EudraVigilance Data Analysis System (EVDAS) marketing authorisation holders (MAHs) dashboard.

The report, along with the EVDAS line listing and active substance grouping reports, will provide the required access and tools to perform signal management activities in the EudraVigilance system, for the MAHs involved, in the one year pilot which starts on 22nd February 2018.

MAHs involved in the pilot are those who have medicinal products containing active substances or combinations of active substances which have been included in the list for the pilot published by EudraVigilance on 25th October 2017.

MAHs that are involved in the pilot should ensure that their “first screening includes all drug-event combinations (DECs) with new cases reported to EudraVigilance on or after 22 February 2018. There is no obligation for MAHs to analyse DECs for which no new cases were reported to EudraVigilance on or after 22 February 2018.”

The Agency aims to make the fixed eRMR report available during February 2018.

For further details on the signal management pilot, please refer to the information published on the EMA’s signal management webpage.

To read the updated EudraVigilance User Manual for MAHs, please click here.