The European Medicines Agency (EMA) has released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database, for a two-month public consultation. All stakeholders are invited to send comments on the draft guidance document no later than July 27, 2014.
The European Union's (EU) pharmacovigilance legislation has given the EMA responsibility for the monitoring of scientific and medical literature for a defined list of active substances used in medicines.
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 authorizations 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," said EMA in a statement. "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."
The draft guide describes the technical aspects of literature monitoring services to be provided by the agency, which include:
- an explanation of how the lists of active substances and publications covered by the monitoring will be selected, updated and shared with marketing-authorization holders;
- details on the screening process and subsequent recording of adverse reaction reports;
- processing of idenified individual cases related to suspected adverse reactions into EudraVigilance.
Given that there are specialized organizations established that already have the necessary experience and knowledge in this area, the EMA will outsource the monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance to an external service provider.