Dr. Arinder Sihota, PhD

Drug Safety Manager

In October, the European Medicines Agency (EMA) released their much anticipated Go-Live plan following input from all of the National Competent Authorities in the European Economic Area (EEA). The Go-Live plan includes a 10 day EudraVigilance downtime from 8 November to 21 November 2017 to allow for the migration of 11 million Individual Case Safety Reports (ICSRs) from the current database. 

The EMA has stressed that it is vitally important that the transition is not in haste with the sheer volume of data involved. The public health benefits with the new system and the operational benefits for stakeholders and regulators will provide a robust basis for pharmacovigilance and signal management activities for years to come.

The new EudraVigilance will allow for submissions to be carried out in ICH E2B(R3) format. Any submissions being carried out via the WebTrader or EVWeb function in EudraVigilance will need to be in ICH E2B(R3) format, this is applicable for sponsors and Marketing Authorisation Holders (MAHs).  MAHs also need to be prepared for cases downloaded from EudraVigilance which will also be in ICH E2B(R3) format.

In case an MAH does not hold an ICH E2B(R3) compliant database they should ensure that they have a tested and validated Backwards and Forwards Conversion tool (BFC) available for use. As a further contingency and depending on the case volumes expected, the EudraVigilance Workspace can also be used to download human readable forms of the ICH E2B (R3) xmls to perform manual data entry into your safety database. Gateway submissions can continue in ICH E2B (R2) format if you are yet to upgrade your safety database.

In addition to the above, 22 November 2017 is the start date for when MAHs will have greater access to ICSRs for signal detection activities, simplified reporting and a requirement for submitting all EEA non-serious cases to EudraVigilance.

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The EMA Go-Live plan

The plan is complex and each National Competent Authority (NCA) has stipulated their own specific requirements. Iceland have released additional information on their webpage with some updated requirements compared to those provided in the plan. In addition, Germany have requested for manual data entry of cases to their local portal. Some NCAs have requested for line-listings during the downtime. BfArM and MHRA have stipulated that EudraVigilance gateway submissions will still be possible. Finally, EVWeb submissions, XEVMPD entries and registrations will not be possible; however, the XCOMP environment will be available.

MAHs and sponsors will then have from 22 November 2017 until 24 November 2017 to submit all cases received during the downtime into EudraVigilance. In order to ensure compliance it is highly recommended to prepare cases in the XCOMP environment for EVWeb during the downtime to reduce the workload from the Go-live. This of course necessitates that all data required to create an ICH E2B(R3) case are available from the start of the downtime, such as deficiency lists to enable the accurate population of nullflavors.


Signal detection in the EudraVigilance Data Analysis System (EVDAS) and ICSR download functionality by MAHs

Access to EVDAS and ICSR download function is at EudraVigilance Headquarter level. The level of visibility of the ICSRs will also depend on how the product is entered in XEVMPD. It is advisable to merge separate EudraVigilance Headquarter profiles for MAHs where affiliates have been registered separately. From 22 November it will be possible for QPPVs to register users for L2B access to allow for narrative requests if not already done so and we will finally be able to access the EVDAS environment.

Transitional arrangements for MAHs

In July, the EMA announced that they would offer a grace period to streamline the monitoring of EudraVigilance while MAHs were familiarising themselves with the new systems and finalising their own processes. During a pilot period of one year, only MAHs whose active substances have been included in the list of medicines under additional monitoring on 22 November 2017 would be mandated to monitor EudraVigilance and inform the EMA and national competent authorities of validated signals with their medicines. The requirement for medicines under additional monitoring will start on 22 February 2018. 

Getting ready

Taking into account the new regulations, the downtime and the go-live date the following actions are advised for readiness: 

  • Arrange for your representatives to attend  relevant EMA stakeholder meetings and trainings  
  • Develop implementation and roll-out plans to include procedural updates, training, extra resourcing and system validations
  • Contact NCAs for their specific requirements to ensure compliance with all of the upcoming changes
  • Devise a change management plan to allow you to  adapt quickly to the new and updated information as it becomes available from EMA 

Our pharmacovigilance and drug safety team has been working with a multitude of MAHs and sponsors that have various portfolios and requirements to ensure readiness. If you require assistance in understanding the new regulations and how they impact your business, we are available to support you to assure compliance. 

For more information ICONplc.com/pharmacovigilance

Dr. Arinder Sihota, PhD
Drug Safety Manager