Operation of EudraVigilance and release of 5.0

On 14th February 2018, EudraVigilance release 5.0 was launched in accordance with the EudraVigilance Auditable Requirements project plan, and as announced prior to the go-live of the new and enhanced EudraVigilance system on 22nd November 2017.

Release 5.0 aims to deliver improvements and address issues that were identified after the go-live on 22nd November. EudraVigilance now holds information on more than 12.45 million safety reports, referring to 7.95 million cases, as well as information on 744,219 medicinal products on the European Union (EU) market. EudraVigilance contributes to the protection and promotion of public health by allowing effective reporting, and a large data set for monitoring of adverse drug reaction data and detection of risk related to the safety of medicines.

Some of the key updated features of release 5.0 include a warning message that will now be created if a valid Unified Code for Units of Measure (UCUM) unit is used in data elements for which the units are not applicable. Furthermore, the published UCUM list includes a column to indicate if the unit is applicable for a specific ICSR data element or not and the business rules now validate that correct use.

The European Medicines Agency (EMA) states that “as part of the automatic classification of medicinal product information reported in ICSRs, a number of reports are pending for download by the dedicated EudraVigilance download functionality. These reports will be made available as part of the routine downloads shortly after release 5.0.” This has been highlighted as this may increase the volume of ICSR downloads for some Marketing Authorisation Holders (MAHs) for a short period of time.

The ‘ad hoc’ reference period electronic Reaction Monitoring Report (eRMR) for MAHs was released on 22nd January 2018 in line with the transitional arrangements agreed by EMA and the European Commission to streamline the monitoring of EudraVigilance and the pilot period of one year, which will start on 22nd February 2018. For MAHs involved in the pilot, the eRMR with the line listing and active substance grouping reports provide access and tools to carry out signal management activities in EudraVigilance.

As previously announced as part of the EudraVigilance Data Analysis System (EVDAS) release notes, the fixed-duration eRMR will become operational on 14th February 2018.

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