EMA to Monitor Select Medical Literature for Drug Side Effects

Regulatory NewsRegulatory News | 12 May 2015 |  By 

The European Medicines Agency (EMA) is launching a new initiative to monitor selected medical literature to proactively identify suspected adverse drug reactions (ADRs) for some 400 active substances.

Pharmacovigilance in the EU

Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected ADRs. This information is incredibly important to ensuring patient safety after a product has been approved.

The primary legal basis for pharmacovigilance requirements in the EU are found in Article 57 of Regulation (EC) No. 726/2004 and Title IX of Directive 2001/83/EC. In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which are collectively known as the new pharmacovigilance legislation.

Monitoring Medical Literature

Under Article 27 of Regulation (EU) No. 1235/2010, EMA is required to monitor the medical literature for ADRs:

"The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances. It shall publish the list of active substances being monitored and the medical literature subject to this monitoring."

The agency says this will "improve the safety monitoring of medicines by enhancing the quality and consistency of data" entered in the EudraVigilance database.

Beginning in July 2015, EMA will begin monitoring the selected medical literature for the first 50 substances it has identified. The agency expects to expand its monitoring operations to all 400 substances by September 2015.

The active substances EMA will be monitoring include many common active ingredients such as ibuprofen, diclofenac and lidocaine, and herbal ingredients such as echinacea and aloe.

EMA estimates that 4,000 companies will benefit from this service as they will not be required to monitor the selected publications for the active substances identified by the agency, though they will be required to monitor other medical literature for suspected ADRs relating to their products.

The agency has released a detailed guide, a chart of inclusion/exclusion criteria, as well as the full list (Excel) of monitored substances as part of its medical literature monitoring service.


EMA Press Release


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