The publication of the draft guideline comes as part of EMA’s responsibilities under the European Union’s (EU’s) pharmacovigilance legislation. This new law has given EMA the responsibility of monitoring the scientific and medical literature for a defined list of active substances used in medicines. The agency acknowledges that there are already specialized organizations established with the necessary experience and knowledge in this area. The agency will therefore outsource the monitoring and entry of relevant information into EudraVigilance, the EU pharmacovigilance database, to an external service provider.

A key objective of this initiative is to improve safety monitoring of medicines by improving the quality of the safety information entered into EudraVigilance. In addition, this should reduce costs for industry by relieving companies holding authorizations for the monitored substances from having to enter the literature cases into EudraVigilance. This 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.

EMA has defined a range of substances including herbal substances for the purpose of the literature-monitoring services. These substances have been selected on the basis of being active ingredients for medicinal products with high numbers of authorizations in the EU.

The draft guideline describes the technical aspects of literature monitoring services to be provided by EMA, 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
• the process of identifying individual cases related to suspected adverse reactions and entering into EudraVigilance.

Monitoring of medical literature and the entry of relevant information into the EudraVigilance database
Released for consultation: 5 June 2014
End of consultation: 27 July 2014
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/06/WC500167985.pdf

Comments on the draft guideline can be submitted to mlm@ema.europa.eu until 27 July 2014. EMA does not state when it expects a finalized guideline to be ready.

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