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 Module 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:
- avoid duplication of effort by marketing authorisation holders;
- prevent the same reports being entered into databases by multiple marketing authorisation holders;
- enhance the quality and consistency of data reported;
- improve the safety monitoring of medicines.
The service has been fully operational since September 2015. The legal basis is Article 27 of Regulation (EC) No 726/2004.
|Active-substance and herbal-substance groups covered|
For more information, see:
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.
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 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.
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.
- 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.
Individual case safety reports (ICSRs) resulting from EMA’s medical literature monitoring service follow this process:
- Electronic transmission to the EudraVigilance Gateway.
- Rerouting to national competent authorities in EEA Member States.
- 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:
- re-submit the ICSRs resulting from the service to EudraVigilance (suspected serious adverse reactions from outside the EEA);
- forward or provide the ICSRs resulting from the service to the concerned national competent authorities in the EEA.
Member States should not:
Guide on the steps of the medical literature monitoring business processes
|Inclusion/exclusion criteria for processing individual case safety reports||Inclusion and exclusion criteria for processing ICSRs|
|Process description for managing duplicates in the context of the medical literature monitoring service||Process description for managing duplicates in the context of the medical-literature-monitoring service and EudraVigilance|
|Questions and answers on medical literature monitoring||Response to first set of frequently asked questions EMA received from marketing authorisation holders|
|Contractor SOPs and WINs||Business 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|
A 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: