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.

Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the European Medicines Agency (EMA) has recently announced that the marketing authorisation holders (MAHs) of 300 specific active substances and combinations of active substances will be required continuously to monitor activities in relation to their substances in EudraVigilance. The scheme will begin on 22 February 2018 and will last one year. During the pilot period, the affected MAHs will be required to inform the EMA and national competent authorities of validated safety signals relating to their medicines. MAHs who are included in the pilot scheme should refer to the guidance contained in the Good Pharmacovigilance Practices (GVP) Module IX – Signal Management in relation to the monitoring and reporting of safety signals. MAHs who are not part of the pilot scheme will not be required to monitor EudraVigilance or to inform the regulatory authorities of validated signals while the scheme is in operation. However, they will have access to EudraVigilance data and will be able to incorporate any relevant new safety data into their own safety monitoring systems. The EMA will use the experience gained during the pilot period to improve the next phase of safety signal detection.

Continue Reading EudraVigilance—safety signals pilot scheme

A quick note to inform you that the EMA launched its new improved version of the Eudravigilance system on 22 November 2017. It is now mandatory to report suspected ADRs through the new system.

The new system has been designed to offer “enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders”. It will be interesting to monitor whether the system delivers these improvements, as time passes, and users become more familiar with it.

For further information, please refer to our previous blog and the attached guidance.

In advance of the launch of the new EudraVigilance System, on 22 November 2017, the EMA has published (on 5 July 2017) a 29 page Q&A, which is a summary of the broad ranging pre-launch questions submitted by stakeholders and the EMA’s answers. Answers have been kept succinct, with URL links to any further relevant guidance. The document is split into separate topics, including: Eudravigilance organisation and user registration;  Reporting to National Competent Authorities in the EEA; and Technical Questions, with an index and a useful glossary of terms at the beginning of the guide. The Q&A will be updated regularly. The EMA recommends that the Q&A be treated as a first reference point for queries, before users contact the Agency’s service desk.

Continue Reading EudraVigilance – What’s next?