By Paul Barrow, Associate Director, Commonwealth Informatics
This November marked a significant change for signal management following the EU pharmacovigilance legislation with Marketing Authorisation Holders (MAHs) receiving access to EudraVigilance data for signal detection for the first time.
MAHs will be granted access starting in December. A one-year pilot starts three months later on 22 February 2018 when MAHs are required for to perform signal detection for a limited set of products. Significant efforts are being made across pharmacovigilance departments preparing processes and teams to review this new source of data, although it is not yet clear what additional volume of work to expect.
Preparations in progress
The EMA put a comprehensive plan of communications in place and have been delivering updates via information days, webinars and through training materials. Highlights from the Signal Management Information day held on 27 October 2017 included updates on preparations for the pilot by regulators, how to obtain signal detection data (electronic Reaction Monitoring Report, eRMR) in the EudraVigilance Data Analysis System (EVDAS) and a live demonstration of how to download case narratives in using EVWEB when required to support signals review.
Some of the larger companies shared updates from their preparations for the start of the pilot with these largely focusing on ensuring business processes are defined and staff training completed.
The work on monitoring eRMR also brings renewed focus on the EMA guidance for “Screening for adverse reactions in EudraVigilance” and whether the general scientific points made in this guidance should be applied to other databases screened by MAHs. For example, the consideration of subgroups for paediatric and elderly.
Scope of products included in EudraVigilance monitoring pilot
The year-long pilot is limited to products included on the European additional monitoring products list rev 49 (published on 25 October 2017). The list of products included in the pilot is fixed based on this revision of the additional monitoring list and will not change even as the additional monitoring list changes during the coming year. The scope of monitoring will be extended to all products with EEA authorisations from 22 February 2019.
Although the requirement to monitor EudraVigilance data for all products with a Marketing Authorisation in the EEA only starts in February 2019, some companies appear to be planning to phase in the monitoring of all products well before the pilot is over. For companies with a significant number of product in the pilot, it was recommended that introduction of EudraVigilance monitoring be phased over the three month November to February 2018 grace period to avoid a large spike in workload.
It is a priority for MAHs to ensure processes for managing the new data source are being put in place and staff are trained. The EMA have contacted MAHs to advise about requesting access to the, initially at least, five EVDAS user accounts which give access to download eRMRs – it is important to ensure this is all in place so the processes can be tested ready for starting in Feb 2018.
It is also important to ensure data submitted on authorised medicines to the European Article 57 database are up-to-date. This is used as the basis to determine access to EudraVigilance case data and narratives in EVDAS as set out in the EudraVigilance access policy.
Commonwealth is working to provide efficient solutions to manage EudraVigilance monitoring alongside existing sources of data used for signal detection. To learn more about how Commonwealth can help you manage your EudraVigilance data please contact us.
- EudraVigilance change management – plan of communications
- EudraVigilance training and support
- European additional monitoring products list (rev 49)
- Data submission on authorised medicines (Article 57)
About the Author
Paul Barrow is currently an Associate Director at Commonwealth Informatics where he works collaboratively with clients helping to optimize their signal detection processes and methodologies by leveraging capabilities in the Commonwealth Vigilance Workbench (CVW). Paul has over 14 years of experience working in pharmacovigilance (PV) and drug safety at the UK Medicines and Healthcare Regulatory Agency (MHRA) and at Takeda Pharmaceuticals. While at MHRA, Paul worked on numerous projects including policy and enhancing MHRA tools to promote safety reporting from patients and healthcare data sources and was a contributor to the SCOPE and WEB-RADR projects.