FDA and EMA Announce Updates to Adverse Event Reporting Systems

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Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

FDA and the European Medicines Agency (EMA) have separately announced updates to their respective adverse event reporting systems. On Sep. 28, 2017, FDA announced the launch of a new dashboard feature that offers a user-friendly search tool to improve access to data on adverse events associated with drug and biologic products through FDA’s Adverse Event Reporting System (FAERS). On Oct. 4, 2017, EMA similarly announced that it is in final preparations for the launch of a new system for reporting adverse events to authorized medicines or medicines undergoing clinical evaluation.

FAERS, a database containing adverse event reports, medication error reports, and product quality complaints resulting in adverse events that are submitted to FDA, is a tool that helps the agency look for new safety concerns possibly related to a marketed product. The system is also used to evaluate manufacturer compliance with reporting regulations and responding to outside requests for information.

The new dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or to search within a specific timeframe. In addition to making the data more easily accessible to consumers, the agency hopes to increase transparency and encourage the submission of more detailed and complete reports from consumers, healthcare professionals, and others.

“FAERS can be a valuable tool, but it is just one of many data sets that helps inform the agency of possible problems associated with a product,” said FDA Commissioner Scott Gottlieb, MD, in an Oct. 2, 2017 statement.

“While the FAERS dashboard now offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their healthcare professional if they have any concerns regarding their medications,” Gottlieb stated.


EMA will launch a new and improved version of its adverse event reporting system, EudraVigilance, on Nov. 22, 2017. EudraVigilance is an information system of suspected adverse reactions to authorized medicines or medicines that are being studied in clinical trials in the European Economic Area. The new system will have enhanced features for reporting and analyzing suspected adverse reactions to strengthen safety monitoring and offer a more efficient reporting process for stakeholders.

The change-over to the new system requires the transfer of more than 11 million individual post-authorization and clinical-trial safety reports, in addition to associated information. To allow the accurate transfer of data, some functionalities of the system will be entirely or partially unavailable from Nov. 8–21, 2017. The agency is putting into place alternative reporting arrangements to ensure consistency during this downtime.

Source: FDA, Statement by FDA Commissioner, and EMA