Medical literature monitoring

The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature, to help identify suspected adverse reactions to medicines authorised in the European Union (EU). EMA also enters relevant information into the EudraVigilance database.

The medical literature is an important source of information for the identification of suspected adverse reactions to authorised medicines.

Marketing authorisation holders of medicines in the European Economic Area (EEA) are usually responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions into EudraVigilance and national safety databases. This is in line with PDF iconModule VI of good pharmacovigilance practices (GVP).

However, for a number of substances with many marketing authorisations and multiple marketing authorisation holders in the EEA, EMA provides a medical literature monitoring service. This service aims to:

The service has been fully operational since September 2015. The legal basis is Article 27 of Regulation (EC) No 726/2004.

Substances and medical literature covered by EMA’s service

Active-substance and herbal-substance groups covered
Databases used

For more information, see:

Search parameters

EMA can only monitor a certain number of substances, based on its allocated budget for these activities, which is subject to an annual review.

EMA selects these substances on the basis of information submitted to EMA's Article 57 databse by marketing authorisation holders.

It prioritises substances contained in medicines with many marketing authorisations and multiple marketing authorisation holders.

Update: In June 2020, EMA added nine additional active substances (chloroquine, darunavir, emtricitabine-tenofovir, filgrastim, ivermectin, nitric oxide, oseltamivir, prednisone and ritonavir) which are being investigated as potential treatments for COVID-19, and for which there are multiple marketing authorisation holders in the EEA.

It is also adding COVID-19-related search terms to its regular literature searches for six active substance groups (azithromycin, ciclosporin, dexamethasone, hydrocortisone, ribavirin and prednisolone) that were already included in the service.

COVID-19-related literature searches commenced on 1 June 2020 in EMBASE, and will commence on 1 July 2020 in EBSCO.

Marketing authorisation holders' monitoring and reporting requirements

Marketing authorisation holders are usually responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions into EudraVigilance and national safety databases.

However, they are not required to monitor or report suspected adverse reactions from the medical literature EMA monitors to EudraVigilance for active substances covered by EMA's service.

EMA makes the individual cases of suspected adverse reactions it finds in the literature available to marketing authorisation holders, so that they can include them in their safety databases and meet their reporting obligations outside the EEA.

Marketing authorisation holders should note that they are required to monitor and report to EudraVigilance suspected adverse reactions:

  • recorded in all medical literature for active substances that are not covered by the service;
  • recorded in medical literature that EMA does not monitor as part of its service, including for active substances that are covered by EMA's service.

For more information, see Article 107 of Directive 2001/83/EC.

Business processes for individual case safety reports from EMA’s service

Individual case safety reports (ICSRs) resulting from EMA’s medical literature monitoring service follow this process:

  1. Electronic transmission to the EudraVigilance Gateway.
  2. Rerouting to national competent authorities in EEA Member States.
  3. Made available to concerned marketing authorisation holders via the ICSR download area of EVWEB.

This process covers ICSRs of suspected serious and non-serious adverse reactions occurring within and outside the EEA.

Marketing authorisation holders can download the ICSRs in XML format in compliance with the Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs).

To be able to access the ICSRs, marketing authorisation holders should either:

  • be EVWEB users;
  • have their safety system configured to be able to download ICSRs with the Sender identifier “MLMSERVICE”.

Marketing authorisation holders should not:

Member States should not:

Guidance

DOCUMENTDESCRIPTION

PDF iconDetailed guide

Related documents:

Guide on the steps of the medical literature monitoring business processes

PDF iconInclusion/exclusion criteria for processing individual case safety reports Inclusion and exclusion criteria for processing ICSRs
PDF iconProcess description for managing duplicates in the context of the medical literature monitoring serviceProcess description for managing duplicates in the context of the medical-literature-monitoring service and EudraVigilance
PDF iconQuestions and answers on medical literature monitoringResponse to first set of frequently asked questions EMA received from marketing authorisation holders
Package iconContractor SOPs and WINsBusiness process documents developed by the contractor in support of the activities in scope of the medical literature monitoring service. These include standard operating procedures (SOPs) and work instructions (WINs) and cover activities performed by the contractor as part of the medical-literature-monitoring service

Training and support

series of short training videos is available to explain the following topics:

  • Legal background and benefits;
  • Details of the scope and key business processes
  • Business-process steps
  • EudraVigilance's functionalities

Training slides and user manual for EudraVigilance are also available:

The Medical Literature Monitoring Service Desk is available to help marketing authorisation holders and national competent authorities.

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