European Medicines Agency boosts EU transparency

The European Medicines AgencyThe European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency's continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

The published information relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.

A side effect (also known as an adverse drug reaction) includes side effects arising from use of a medicine within the terms of the marketing authorisation as well as from use outside the termsof the marketing authorisation, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure.

All information on the website relates to suspected side effects. Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful. All users of the website are asked to read and accept a disclaimer explaining how to understand the information before they view a web report.

Medicines are an important part of modern healthcare, providing effective treatments for many diseases and conditions. For a medicine to be authorised for use in the EU the benefits of the medicine must always outweigh the risks.

Today's launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the European Union. Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection.

In June, the Agency will launch the website in the remaining 22 official EU languages.

The European database of suspected adverse drug reaction reports: http://www.adrreports.eu

Most Popular Now

A step closer to cancer precision medicine

Researchers from the Faculty of Medicine and the Institute for Molecular Medicine (FIMM) at the University of Helsinki have developed a computational model, Combined Esse...

Artificial Intelligence algorithm can learn the la…

Artificial Intelligence can be used to predict molecular wave functions and the electronic properties of molecules. This innovative AI method developed by a team of resea...

Amgen completes acquisition of Otezla® (apremilast…

Amgen (NASDAQ:AMGN) today announced the successful completion of its acquisition of worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for mo...

Bristol-Myers Squibb completes acquisition of Celg…

Bristol-Myers Squibb Company (NYSE:BMY) has completed its acquisition of Celgene Corporation (NASDAQ:CELG) following the receipt of regulatory approval from all governmen...

Amgen and the Duke Clinical Research Institute ann…

Amgen (NASDAQ:AMGN) in collaboration with the Duke Clinical Research Institute (DCRI) announced plans to initiate the Cardiovascular Multi-dimensional Observational Inves...

Statins not associated with memory or cognition de…

Given consumer concern that statins may be associated with memory or cognitive decline, a new study published today in the Journal of the American College of Cardiology m...

Novartis announces new strategy to provide innovat…

Novartis announced a new strategy to broaden patient reach and availability of its portfolio of medicines in sub-Saharan Africa (SSA), which is home to the largest unders...

New advances in the treatment of advanced lung can…

The University of Barcelona (UB) and Hospital Clínic de Barcelona collaborate with Boehringer Ingelheim Inc. to improve the efficiency of nintedanib, an antiangiogenic an...

FDA grants priority review to Roche’s risdiplam fo…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for ...

A protein tag to study the immune system

Researchers from VIB-UGent Center for Medical Biotechnology, University of Iowa (USA) and other collaborators, developed a novel approach to better understand a basic def...

Bayer and Dewpoint Therapeutics partner to researc…

Bayer and Dewpoint Therapeutics, a biotechnology company with sites in Boston and Dresden, Germany, today announced an option, research and license agreement worth up to ...

Bristol-Myers Squibb and Pfizer announce randomize…

The Bristol-Myers Squibb-Pfizer Alliance today announced the initiation of a new randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRi...