The medical literature monitoring (MLM) is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Hence, it is important to review suspected adverse reaction gathered from scientific journals, medical researcher, relevant published abstract and draft manuscripts.
Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Pubmed, Medline, Excerpta Medica or Embase) no less frequently than once a week.
In addition, marketing authorization holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorization, and to bring them to the attention of the company safety department as appropriate.
The expense and efforts required to obtain important safety information from the vast amount of published literature in many languages and countries of the world is a rather challenging task.