The European Medicines Agency (EMA) is 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.
The medical literature monitoring (MLM) service is fully restored following the go-live of the new EudraVigilance system on 22 November 2017. This means that:
The service is fully operational as of 1 September 2015.
Scientific and medical literature is an important source of information to identify suspected adverse reactions with medicines authorised in the European Economic Area (EEA).
In line with the guidance in Good Pharmacovigilance Practices (GVP) Module VI, marketing-authorisation holders are required to monitor medical literature and to report individual cases of suspected adverse reactions for medicines for which they hold a marketing authorisation in the EEA. This has led to duplication of efforts by marketing-authorisation holders for active substances included in more than one medicine, and duplication of reports entered into EudraVigilance and national safety databases.
The monitoring of medical literature and the entry of relevant information into EudraVigilance will be carried out by EMA in order to:
The legal basis for the EMA's tasks is Article 27 of Regulation (EC) No 726/2004, which states that:
In accordance with Article 107, paragraph 3 of Directive 2001/83/EC, marketing-authorisation holders shall not be required to report to EudraVigilance suspected adverse reactions recorded in the listed medical literature monitored by EMA for products containing the active substances referred to in the list of substances being monitored by EMA.
It is important to note that marketing-authorisation holders shall monitor all other medical literature and report any suspected adverse reactions.
A range of active substance, including herbals, have been selected on the basis of medicinal product information submitted to EMA in line with Article 57(2), second subparagraph of Regulation (EC) No 726/2004. Active substances contained in medicines for which a high number of marketing authorisations were granted to various marketing-authorisation holders in the EEA are included in the service.
The lists of substance (mainly chemical) and herbal-substance groups which are subject to the monitoring activities by the Agency are published in the below document:
The total number of all substance groups included in the medical literature monitoring service is based on the Agency’s allocated budget for these activities and will be subject to annual review.
More than 3,500 marketing-authorisation holders in the EEA for the substance groups benefit from the service, and more than 640 marketing-authorisation holders for the herbal substance groups.
The medical literature covered by the medical literature monitoring service has been designated in line with GVP Module VI, and is based on the use of literature reference databases by the Agency’s contractor as outlined in the below document:
The Agency has drawn up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database, which defines the different steps of the MLM business processes. It was drawn up in consultation with the European Commission, Member States and interested parties. See the below document:
Additionally, in support of the medical literature screening activities and the processing of individual case safety reports, inclusion and exclusion criteria have been prepared based on the principles set out in Good Pharmacovigilance Practices (GVP) Module VI. See the below document:
A process description for managing duplicates in the context of the medical literature monitoring service and EudraVigilance is provided below.
A questions and answers document is available that addresses a first set of frequently asked questions from marketing authorisation holders. This document will be regularly updated based on further questions received.
The Agency has approved 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.
As of 1 September 2015, the service is fully operational and covers 300 active substances and 100 herbals.
In its launch phase between 1 July and 31 August 2015, the service covered the top 50 active chemical substance groups. For more information on the launch phase and its outcomes, see:
In order to monitor the key performance indicators as stated in the launch phase closure report, the medical literature monitoring (MLM) service will continue to track these against the targets assigned. The latest results can be found in the below report:
EMA has prepared a series of short videos to provide further information on the new medical literature monitoring service and these videos can be viewed below.
The following topics are covered:
The training slides and user manual of the new EudraVigilance functionalities can be accessed here:
Since the service launch in July 2015 EMA has been organising support webinars which will continue throughout 2016 on a monthly basis. These are scheduled for the following dates (UK time):
Expressions of interest to participate in the webinars should be sent to firstname.lastname@example.org indicating the date for each event of interest. Every webinar is restricted to a maximum of 200 attendees and a first-come, first-served policy will be applied.
The search parameters for all 300 active chemical substances and 100 herbal substances to be applied during the full production phase are provided in the below document. Minor revisions may be made based on the start-up phase findings:
Sample outputs of ICSRs in XML format are to be published routinely in the restricted area of the EudraVigilance website accessible by registered users. Further information can be found in the below documents:
For all queries in relation to the new service, please send an e-mail to email@example.com.
The high-level technical environment requirements and pre-requisites for concerned marketing-authorisation holders are described below:
The adaptations of business processes by concerned marketing-authorisation holders are summarised as follows (refer to Figure 1a).
Figure 1a: New medical literature monitoring business process - main steps with regard to the electronic transmission of ICSRs resulting from the medical literature monitoring service to national competent authorities in the EEA and the download of ICSRs for marketing-authorisation holders from the EudraVigilance download area.
The business processes to be discontinued by concerned marketing-authorisation holders are summarised as follows (refer to Figure 1b):
Figure 1b: Existing business processes of national competent authorities and concerned marketing-authorisation holders to be discontinued with regard to the electronic transmission of ICSRs resulting from the medical literature monitoring service operated by the Agency.
The document reporting requirements of ICSRs applicable to marketing-authorisation holders during the interim period (EMA/321386/2012) has been updated to include a new chapter on “Reporting requirements of literature reports” with the aim to clearly define the reporting requirements for marketing authorisation holders for adverse reactions reported in the literature and taking into account the Agency’s activities in accordance with Article 27 of Regulation (EC) 726/2004.
EMA is supported in the delivery of its service of monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance by a contractor. A service desk is operated to assist in dealing with enquiries from MAHs and NCAs in EEA Member States. The working language of the service desk is English. The working hours are the same as the EMA business hours.
All enquiries should be sent to firstname.lastname@example.org.
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