EMA’s Medical Literature Monitoring Service Kicks into Full Operation

The European Medicines Agency’s medical literature monitoring service kicked into full operation last week, allowing drugmakers to easily search for information on adverse reactions associated with their products.

The service, which launched a test run July 1 covering 50 active substances, now monitors information on 300 chemical and 100 herbal active substances. Information on suspected ARs is entered into the EudraVigilance database by the EMA — relieving drugmakers of having to enter it themselves.

Individual cases of suspected ARs will be made available to marketing authorization holders so they can include them in their safety databases and meet reporting obligations outside the European Economic Area, the EMA says.

Other expected benefits include enhancing the quality and consistency of adverse event data, and reducing the number of duplicate reports.

Drugmakers should check to see if their medicines are covered by the service, the EMA says.

Read New Functionalities in Support of the Medical Literature Monitoring Service here: www.fdanews.com/9-15-EMA-Manual.pdf. A Question & Answer document is available at www.fdanews.com/9-15-EMA-QA.pdf. — Jonathon Shacat