The European Medicines Agency (EMA) launched last May 31st the new European database of suspected adverse drug reaction reports website.
The information carried on the site relates to approximately 650 medicines and active substances authorised through the centralised procedure. Within a year the EMA aims to additionally publish suspected side-effect reports for common drug substances used in nationally-authorised medicines.
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.
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 terms of 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.
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.
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.