What is Global Literature Monitoring?
Published medical and scientific literature is a valuable source of information regarding medicinal products and medical devices. And Marketing Authorisation Holders (MAHs)/Licence Holders are required to monitor the literature for suspected Adverse Drug Reactions (ADRs) and other important safety information such as class effects, off-label use, misuse and potential drug interactions. It is required that upon submission of a MA application, the MAH will conduct at least weekly searches of the global literature to identify any emerging safety information.
Global literature screening is an activity that needs to be performed regularly in large biomedical databases that include the majority of scientific and medical journals. Articles retrieved during global literature searches can be written in any language.