The new EudraVigilance drug safety monitoring system has now been up and running for nearly 5 months, and the EMA has recently published an updated Q&A, featuring questions submitted by users, either through the service desk, or following the various technical and pharmacovigilance webinars run by the EMA.

Changes to Q&As

Not surprisingly, there have been some teething problems with the revised adverse drug reaction (ADR) reporting system, and the Q&A now runs to 122 pages. The scope of the document has also been revised. Some of the sections have been removed and will appear in the future as separate documents, e.g. signal detection and management (including Good Pharmacovigilance Practice (GVP) Module IX questions on signal management) and EudraVigilance Data Analysis System (EVDAS) issues. The Go-Live Planning section has been removed entirely, since it is no longer relevant (but obviously still appears in previous versions of the document). While new questions and answers have been added to most sections of the document, the most pressing concerns of stakeholders appear to centre on issues associated with the Individual Case Safety Report (ICSR) download manager, including detailed technical questions regarding its functionality, and more general enquiries relating to accessibility and compliance (Section 2).

Further guidance pending

While the EMA has not yet answered all of the questions posed, it has indicated (in the answer to Question 3.15, concerning the reporting requirements for serious ADRs found in medical literature publications) that it plans to issue “shortly” some clarification on the processing of ICSRs which marketing authorisation holders can download from the system. Hopefully, this will help to allay marketing authorisation holders’ concerns regarding potential compliance issues in this area.

The dossier will continue to be updated as the system becomes more familiar to users, and glitches are ironed out. According to the EMA, the Q&A should continue to be the first port of call for users to resolve their queries, prior to contacting the EMA’s service desk.