EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

Regulatory NewsRegulatory News | 09 June 2014 |  By 

In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse.


Regulators use reports based on this literature differently.

In most regions, the literature is useful in generating hypotheses about side effects, and to alert regulators to possible side effects that may have been unknown at the time of approval, or thought to have existed at lower frequencies or severities.

In the US, the Food and Drug Administration (FDA) has expressed interest in mining literature reports to better assess drug adverse events, and announced in April 2014 that it plans to move forward with the project.

The Case of the EU

Though the EU hasn't yet expressed interest in mining literature reports, it is now out with a new draft guide on how sponsors of medical products should monitor and report information gleaned from medical literature that is relevant to their product.

The guideline comes after the EU passed new pharmacovigilance legislation which charged the agency with monitoring the literature as part of a broader effort to ensure the postmarket safety of medicinal products.

Prior to the legislation, companies were responsible for submitting all literature-based reports to EudraVigilance, an EU-run pharmacovigilance database. This was problematic for two reasons. First, it was time-intensive for companies, and second, it resulted in duplicate reports in cases where more than one company marketed drugs containing the same active pharmaceutical ingredient.

Under the pharmacovigilance legislation, EMA is now charged with monitoring "selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances."

As EMA explains in its announcement:

"A key objective of this initiative is to improve safety monitoring of medicines through better quality of safety information from the literature entered into EudraVigilance, the EU pharmacovigilance database. In addition, it provides a service and reduces costs for industry by relieving companies holding authorisations for the monitored substances from having to enter the literature cases into EudraVigilance. This service and cost saving to industry does not negate in any way the company’s obligations to monitor the safety of their products, but will reduce the administrative burden they face. The draft guide is intended to support the monitoring of substances which are included in multiple products and thus to benefit a maximum number of companies."

New Guide

EMA's new guide, Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency, is meant to explain three things to industry:

  • how EMA selects the substances it will monitor, and how it will share the results of that monitoring process with sponsors
  • how the monitoring process works, as well as how it records adverse events gleaned from the literature
  • how the agency processes individual adverse event reports and records those events into EudraVigilance

As EMA explains in its statement, because outside entities already have significant experience in this area, it plans to outsource the monitoring and entry of reports to an outside service provider.

EMA's consultation on the guide is open through 27 July 2014.


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