Companies and all interested stakeholders have until 27 July to submit their comments on the draft guideline on medical literature monitoring and the inclusion of relevant information in the EudraVigilance database prepared by the EMA.
How is medical literature monitoring changing?
The guideline describes the technical aspects of literature monitoring that must be provided to the Agency, including:
- an explanation of the process used to select the lists of active substances and publications to be monitored, updated and shared with Marketing Authorization Holders;
- details regarding the process for selecting and subsequently recording adverse reaction reports;
- the management of individual cases of suspected adverse reactions identified in EudraVigilance.
Under European pharmacovigilance legislation, the EMA has been assigned responsibility for monitoring the scientific and medical literature relating to a list of active substances used in medicinal products. The main objective of this initiative is to improve drug safety monitoring through higher-quality safety information from the scientific literature entered into EudraVigilance.
“This initiative,” as the Agency states in a communication, “provides a service and reduces costs for the pharmaceutical industry by relieving Marketing Authorization Holders of monitored active substances from the obligation to enter literature cases into EudraVigilance. However, it does not in any way remove the industry’s responsibilities for monitoring the safety of its products.”