EMA's medical literature monitoring enters into full operation

The European Medicines AgencyThe European Medicines Agency (EMA) has started its full medical literature monitoring service on 1 September 2015. A total of 400 active substance groups (300 chemical active substance groups and 100 herbal active substance groups) will now be monitored by EMA. The service will benefit over 4,000 companies. The list of active substance groups and a reference to the journals covered by EMA’s medical literature monitoring service are available on the monitoring of medical literature page. Companies are advised to consult the list to check whether their products are covered by the service.

The implementation of EMA's full service follows a launch phase which began on 1 July 2015 and which included the 50 most common chemical active substance groups.

Medical literature is an important source of information on suspected adverse reactions to medicines. The European Union's (EU) pharmacovigilance legislation has given EMA responsibility for the monitoring of selected medical literature for a defined list of active substances used in medicines and for entering identified reports of suspected adverse reactions in EudraVigilance, the EU adverse drug reaction collection and management system.

By reducing duplication of reporting from multiple pharmaceutical companies, the initiative will improve the safety monitoring of medicines by enhancing the quality and consistency of data reported in EudraVigilance. It is provided as a service to industry which, for the active substances and literature covered by EMA activities, will no longer be obliged to enter information from the literature, on suspected adverse reactions into EudraVigilance. Individual cases of suspected adverse reactions found in the literature will be made available to marketing-authorisation holders so they can include them in their safety databases and meet their reporting obligations outside the European Economic Area.

Webinars are organised by the Agency for interested stakeholders to support the start of the service. Further information, including a guide, a training video and a document detailing the inclusion and exclusion criteria used by EMA when screening the literature are puplished on the monitoring of medical literature page.

EMA has sent updates on the implementation of its medical literature monitoring service to the qualified persons for pharmacovigilance in pharmaceutical companies as well as to pharmaceutical industry organisations.

Most Popular Now

Bayer, Brigham and Women’s Hospital, and Massachus…

Bayer and Partners HealthCare's founding members Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) today announced the launch of a joint lab to ...

AstraZeneca divests rights for Losec to Cheplaphar…

AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arznei...

Cause of antibiotic resistance identified

Scientists have confirmed for the first time that bacteria can change form to avoid being detected by antibiotics in the human body. Studying samples from elderly patient...

Amgen announces positive results from two Phase 3 …

Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (2012021...

Brilinta monotherapy in high-bleeding risk patient…

New data from TWILIGHT, a Phase IV independent trial (funded by AstraZeneca), showed that in patients at high-bleeding risk who underwent PCI and completed 3 months of du...

Novartis and Microsoft announce collaboration to t…

Novartis announced an important step in reimagining medicine by founding the Novartis AI innovation lab and by selecting Microsoft as its strategic AI and data-science pa...

Ian Read to retire as Executive Chairman of Pfizer…

Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to...

FDA approves first oral GLP-1 treatment for type 2…

The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along w...

Discovery of new source of cancer antigens may exp…

For more than a decade, scientist Stephen Albert Johnston and his team at Arizona State University's Biodesign Institute have pooled their energies into an often scoffed-...

Chinese activists protest the use of traditional t…

In the West, the number of people challenging scientific authority has been growing in past decades. This has, among other things, led to a decline in the support for mas...

Cheaper drug just as effective protecting heart in…

A new clinical trial conducted at The Ohio State University Wexner Medical Center found a cost-effective generic medication works just as well as a more expensive drug in...

Dengue virus becoming resistant to vaccines and th…

Researchers from Duke-NUS Medical School (DukeNUS), in collaboration with the Agency for Science, Technology and Research (A*STAR)'s Bioinformatics Institute (BII), and t...