EMA opens up access to reports on suspected drug side effects / Policies & Legislation / Home - GaBi Online

EMA opens up access to reports on suspected drug side effects

Home/Policies & Legislation | Posted 08/06/2012 0 Post your comment

In its commitment to transparency, EMA, on 31 May 2012, opened up access to reports on suspected drug side effects. The database contains reports on around 650 medications and active ingredients, including vaccines. Each entry covers a different drug, with aggregated information on suspected but not proven side effects, also known as adverse drug reactions. The database currently holds information on products that have been authorised within the European Economic Area (EEA) via the centralised authorisation procedure which are managed by EMA. Nationally authorised products will feature in a second wave of access in 2013.

The reports come from the EU medicines safety database EudraVigilance which was created in December 2010 as part of pharmacovigilance legislation developed to improve public health by supporting the safety-monitoring of medicines and to increase EMA’s level of transparency [1]. The reports are being made available via the new website: www.adrreports.eu, and are one of the many types of data that regulators use to monitor the benefits and risks of medicines after authorisation. 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.

Each report is an aggregation of individual notifications of suspected side effects from pharmaceutical companies and national authorities (which gather information from patients, consumers and healthcare professionals). The notifications include those occuring outside of EEA. Users can view the reports according to age, sex, type of suspected side effect and outcome. Visitors must first, however, accept a disclaimer from EMA that emphasises the suspected nature of each report, with the understanding that this does not mean that the drug caused the side effect. On the contrary, it may be coincidental, and hence the data are not appropriate for estimating risk of side effects from a particular medication.

In a statement EMA said ‘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.’

The new move is the result of EMA’s 2010 pharmacovigilance legislation. In June 2012, the Agency will launch the website in the remaining 22 official EU languages.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Pharmacovigilance legislation moves a step closer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 8]. Available from: www.gabionline.net/Policies-Legislation/Pharmacovigilance-legislation-moves-a-step-closer

Source: EMA