Following their March update, the European Medicines Agency (EMA) has just released further communications regarding the upcoming changes set to be implemented to the EVDAS MAH’s Pharmacovigilance Dashboard and, more specifically, electronic Reaction Monitoring Reports (eRMRs).
Within previous communications, industry organisations were informed of the EMA’s intentions to replace ad-hoc reference period eRMR reports with fixed reference eRMR periods; in the hope that this will improve quality of output and reduce both maintenance and MedDRA upgrade downtimes. PharSafer provided a summary of this information in a previous industry update of ours, with regards to the reason for this change and associated timescales for the proposed reference periods – click here.
In summary of their latest update, the EMA has confirmed that their aforementioned plan to improve eRMRs remains pertinent, with no alterations to the plan’s timescale or implementation process; in addition to informing industry organisations that the EVDAS system is currently undergoing the performance testing phase, to ensure that these changes do not have a detrimental impact to system performance.
Furthermore, the EMA has confirmed that the 27th April will remain as the last day for ad-hoc reference period eRMRs, and that the upcoming fixed reference period will continue to become available on the 28th April 2020, within MedDRA version 22.1, and replaced by new fixed reference period eRMRs, within MedDRA version 23.0, on the 5th May 2020.
Prior to the upcoming new fixed reference periods being released on 28th April 2020, the EMA have also confirmed that an updated EVDAS user manual will continue to be made available and also be accompanied by an eRMR calendar – with all dates and reporting periods being made available throughout 2020.
Moreover, the EMA have placed further emphasis on the subject of saving data, in accordance with existing company processes, due to the upcoming inability of retrieving previous eRMRs once new reference periods have been established. However, homogenous to their previous announcement, the EMA have continued to stress that some gaps in information retrieval will be inevitable, due to some MAH’s being unable to adjust data lock points for the signal detection cycles – in addition to the recently upscaled impact of the current COVID-19 pandemic on industry organisations adaptability.
PharSafer has been informed that further updates will be provided by the EMA in due course and we will communicate any new information, regarding this topic, as we receive it.