4. EudraVigilance

1. EudraVigilance

1.5. EudraVigilance webportal: adrreports.eu

EudraVigilance data are published via the webportal adrreports.eu in 26 languages and provide information on reports of suspected adverse reactions (Individual Case Safety Reports, (ICSRs)) for authorised medicines in the European Economic Area (EEA). The output formats include web reports containing aggregated information, using data elements from the reports submitted to EudraVigilance, line listings providing an overview in tabular format about individual cases, whilst individual report forms present more detailed information specific to a case.

This web portal was launched by the EMA in 2012 to comply with the EudraVigilance access policy, developed to improve public health by supporting the monitoring of the safety of medicines and to increase transparency for stakeholders, including the general public. The policy is designed to provide as much information as possible while meeting data protection obligations. A revision of the access policy “Revision 4: update of references in accordance with Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR) and Regulation (EU) 2018/1725, the EU Data Protection legislation (EU DPR)” took place in 2019.

Subsets of data (defined sets of ICSR data elements) from spontaneous reports [1]  listed in Annex B of the EudraVigilance Access Policy, are released, taking into account the EU DPR. This applies to all types of medicines, independent of the authorisation procedure and the source of the report (e.g., healthcare professional, patient).

For centrally authorised medicines, reports can be accessed both by the name of the medicine or the name of the active substance or combination thereof, for non-centrally authorised medicines, by the name of the active substance.

To note:
The information from this web portal relates to suspected adverse reactions, i.e. effects that have been observed following administration of, or treatment with, a medicine. However, these suspected adverse reactions may not be related to, or caused by the medicine or active substance.

Therefore information in a web report cannot be used to determine the likelihood of experiencing a particular adverse reaction caused by the medicine in question. The information cannot be used in isolation to decide upon the benefit-risk balance of a medicine. Other information, such as how many people take the medicine and how long it has been on the market, needs to be considered. Moreover, apart from the spontaneous reports arising from the use of a medicine worldwide, information can also be gathered from additional sources, such as clinical trials and epidemiologic studies, scientific literature, rates of morbidity (incidence of disease in a population) and of mortality (incidence of death in a population). Sometimes, additional investigative studies, and consultations with other medicines regulatory authorities, are necessary to assess the likelihood that a suspected adverse reaction is linked to a medicine, to identify risk factors, and to estimate the frequency of occurrence. Only the assessment of all available data allows for robust conclusions on the benefits and risks of a medicine to be drawn. In essence, any individual case report should be seen in the context of all available data on the medicine.

[1] Spontaneous reports are unsolicited reports by healthcare professionals or patients that do not derive from a study or any organised data-collection scheme.