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Mar 27
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EMA Update – Signal Detection Methodology

Following results from a survey conducted in 2019, The European Medicines Agency (EMA) has just announced their intention to change the EVDAS MAHs Pharmacovigilance Dashboard within the coming months; addressing the topic of electronic Reaction Monitoring Reports (eRMRs).

In summary, with logic analogous to the current 6-month reference period eRMR, the EMA Is hoping to enhance the quality of output and reduce downtime, during both maintenance and MedDRA upgrades, through replacing ad-hoc reference period eRMR reports with fixed reference eRMR periods; whilst assuring there will be no changes made to Line Listing and active substance grouping EVDAS reports.

The proposed fixed reference eRMR period is forecasted to be made available on the 3rd of each month, with the following proposed structure:

– 15-Day reference period eRMR
– 1-Month reference period eRMR
– 3-Month reference period eRMR
– 6-Month reference period eRMR
– 12-Month reference period eRMR

However, in any case where the 15-day reference period eRMR is required for the current month, the data will be updated and available as of the 18th of that month, with reference to dates between 1st-15th. Moreover, in regards to the current reference period eRMR, it has been confirmed that 27th April 2020 will be the last day for ad-hoc reference period eRMRs, with 28th April 2020 being the first day that the following fixed reference periods will be available within the current 22.1 MedDRA version:

– 15-Day period: from 01/4/2020 to 15/04/2020
– 1-Month period: from 01/3/2020 to 31/03/2020
– 3-Month period: from 01/1/2020 to 31/03/2020
– 6-Month period: from 01/10/2019 to 31/03/2020
– 12-Month period: from 01/4/2019 to 31/03/2020

The EMA has subsequently advised MAHs to plan their signal detection activities in accordance with the above dates, but to also acknowledge that from 5th May 2020, in line with the upcoming MedDRA version 23.0 update, these dates will be replaced with a new fixed referenced period for eRMRs.

Furthermore, the EMA has also stated that these timescales are subject to change, in the event that implementation is hindered by technical issues – with issues regarding the retrieval of data being forecasted as potentially unavoidable – and that further communications will be provided directly to EVDAS users; whilst also exploring to option of increasing the number of EVDAS users per MAH license, to aid communication efforts.

Lastly, the EMA has again urged MAHs to persist with saving data, in line with their current compliant processes and procedures, and to await further information; including the release of the upcoming EVDAS user manual on April 28th 2020, which will include key dates regarding new reporting periods.

PharSafer intends to keep you informed of all information, as we receive it.

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