EMA MLM is NOT a solution

European Medicines Agency (EMA)’s medical literature monitoring service, called MLM does not cover the literature monitoring obligation of Marketing Authorisation Holders (MAHs). MAHs should be careful about how they interpret the impact of EMA MLM on their literature monitoring, otherwise they may get findings at an inspection. Let’s see what causes the misunderstandings.

Misunderstanding No. 1

MLM service is often interpreted in the way that MAHs can exclude the active substances that can be found in the MLM’s list of monitored substances from their monitoring. This is a wrong interpretation. The right way of putting it is that they do not have to monitor these substances in the journals selected by EMA MLM, but they should screen these substances in journals that match the following rule by EMA: “It is important to note that marketing-authorisation holders shall monitor all other medical literature and report any suspected adverse reactions.”

Misunderstanding No. 2

Another wrong interpretation of MLM service is to stop monitoring the journals that are in the list of MLM. MAHs can only do so if all their active substances are selected for monitoring by MLM. If not, then MAHs cannot exclude the monitoring of any journals because they are obliged to monitor their substances not monitored by MLM in all the journals.

And some more details to consider 

EMA excludes those Individual Case Safety Reports (ICSRs) found during MLM that occur outside EEA and contain suspected non-serious adverse reactions. Furthermore, MAHs are still expected to collect safety data besides ICSRs for aggregated reports such as PSUR.

To sum it up, MAHs are advised to think it over carefully what they can exclude from the literature screening using MLM.

MLM is a service run by EMA, fully operating from 1 September, 2015.

Under the service of MLM, EMA undertakes to “be responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database.”