EMA Releases EudraVigilance Testing Instructions and Checklist for MAHs and Sponsors

With the new EudraVigilance system going live on 22 November 2017, the EMA have provided a checklist and support plan for all marketing authorisation holders (MAHs) and sponsors. This is to help the MAHs and sponsors prepare for the changes that are to come.

The technical checklist talks through the changes that will occur in regard to the ICSR and acknowledgement exchange and the associated IT changes. It states that the EVWEB test environment should be ready to use as of 26 June 2017 so MAHs and sponsors can now test their IT systems and familiarise themselves with the new interface. It also provides testing instructions and e-learning modules to help understand the changes.

The business process checklist provides guidance for MAHs on how best to prepare for the process changes in regard to the adverse event reporting and signal management. The EMA have emphasised that there will be no changes to the reporting of suspected unexpected serious adverse reactions during clinical trials until the application of the Clinical Trial Regulation. They also highlighted that the whole checklist may not apply to sponsors of the clinical trials but will do so for the MAHs.

To for more information on the checklist please click here.