News from the Eudravigilance Information Day

On Tuesday, June 21st 2006, the EMA hosted their first Eudravigilance Information Day for 2016. For those of you who couldn’t attend, here is a summary provided by Marc Zittartz, our Chief Quality Officer at pharmasol.

I think that the most important information to take away from the EudraVigilance Information Day is that the Go-Live date for the start of the centralized reporting (including E2B(R3)) has been postponed by the EMA. Originally planned for Q3 2017 it is now moved to November 2017, giving pharmaceutical companies more time to prepare for it. Perhaps unsurprisingly, the EMA cited performance improvements and resource availability as the reasons for this delay. This impacts the EV stakeholder testing first (previously called the Pilot Testing), where selected companies test the new submission to EudraVigilance. All dependent activities have been moved backwards accordingly. Please be aware that the Change Management Plan on the EMA website has not been updated with the new timelines yet. This will happen in the next weeks.

In other news, EMA is working on new versions for several guidelines.

GVP Module VI is under revision again, and public consultation on the new revision will start in July this year with the goal of finalization by the end of the year. It would only come into effect with the start of the centralized reporting at the end of 2017.

Some of the highlights mentioned:

  • The instructions will take into account the new information in the E2B(R3) format as well as details on how to handle information in the transition phase from R2 to R3.
  • There will be two elements required to identify the reporter, the Qualification and one of the following: Name, Address, Phone
  • Multiple Patient reports must include a patient identifier such as gender, age, age group or patient ID.
  • The Patient Age information is now considered important and should be obtained through follow-up

GVP Module IX is also under revision, and the public consultation should start in July. Some of the highlights mentioned:

  • The guidance on reviewing the data in EudraVigilance is intended to be less strict. Instead of a monthly review, the guidance would allow for up to six months review intervals for substances with an established safety profile, e.g. generics. However, substances under additional monitoring should be reviewed every two weeks.

EMA has also drafted a Reflection Paper on how to deal with Off-Label Use information, with a focus on Off-Label Use without a suspected adverse reaction. This paper is already available on the EMA website and public consultation is currently on-going until the end of July.

So, EMA has been giving us a reading list for the summer vacation and some more time to prepare your systems for the upcoming changes.

Other topics discussed included the Medical Literature Monitoring service provided by EMA. Both agency and company experience were shared. While the start was a little rocky, improvements to the service have been made and will continue to be implemented.

EMA starts with a EudraVigilance Training Plan for stakeholders, which focuses on Pharmacovigilance, EudraVigilance and IT related matters. These trainings will be a mix of e-learning, Webinars and face2face trainings. This is based on the existing trainings but will be expanded in the coming months. Visit the EudraVigilance training webpage for more information.

And finally, EMA is going to move the public information you currently find on the EudraVigilance website to the general EMA website.

If you would like to get more information on these and other topics discussed at the EudraVigilance Information Day, contact us at