EPF is pleased to announce the launch of the new European database of suspected adverse drug reaction reports website at www.adrreports.eu.
Created by the European Medicines Agency (EMA), this website is a positive first step in the implementation of the EudraVigilance Access Policy. Granting patients and the public access to the data held in Eudravigilance – the central EU database for adverse reaction reports – is a key part of the new EU pharmacovigilance legislation. EPF worked closely with EMA in developing the EudraVigilance Access Policy and to ensure that the new portal contains information relevant to patients and is presented in a user-friendly format.
EPF warmly welcomes this new step, as it complements the implementation of direct patient reporting, which we actively supported. In future, patients everywhere in the EU will be able to report directly to their national regulatory bodies if they suspect they have an adverse drug reaction (ADR); this means patients will no longer be obliged to rely on healthcare professionals to submit reports to the authorities. The reports received at national level are submitted to EudraVigilance electronically.
Eudravigilance will be developed to become the single point of collection for reports for the whole of the EU. Patients can access the information on the public website, for example, to search for ADR information on the specific medicine they are taking. The information initially published on the website 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. Language versions of the website in all 23 community languages are set to go live by the end of June.
In order to promote the launch of the new website among patients, consumers and healthcare professionals, the EMA would like to request that organisations include where possible references and links to the new website from their websites.
Please find attached a question and answer document about this online database.
If you need more information about it, here is the link to the press release related to this launch on the EMA website.