The European Medicines Agency (EMA) has today launched a six-week public consultation on its updated EudraVigilance access policy. EudraVigilance is the European database of all suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA). Managed by the EMA on behalf of the EU medicines regulatory network, EudraVigilance receives over one million adverse drug reaction (ADR) reports per year. The large datasets included in the database provide the basis for the continuous safety monitoring of medicines performed by European regulators.
The first EudraVigilance access policy entered into force in 2011. It defined levels of access to information on ADR reports for medicines in EudraVigilance per stakeholder group: for European regulators, for healthcare professionals, consumers and patients, for marketing authorization holders and for research organizations. Access to information from EudraVigilance for healthcare professionals, consumers, patients and the public is provided for centrally authorised products through a dedicated public website.
The proposed update maintains the principles established by the original policy but takes into account the changes to the system of safety monitoring of medicines introduced by the pharmacovigilance legislation, such as the further increase in transparency, the introduction of direct patient reporting across all EU member states, and the pharmaceutical industry's responsibility for monitoring the data in EudraVigilance for new safety issues, following a simplification of the reporting of adverse reaction reports.
Some key changes:
- Addition of the Uppsala Monitoring Centre (UMC) of the World Health Organization (WHO) as a new stakeholder group who will be provided with individual case safety reports (ICSRs) originating from within the EEA in electronic format on a weekly basis;
- Enhanced access of marketing-authorization holders to reports related to their medicines in support of their signal detection and other pharmacovigilance obligations;
- Access to more detailed ICSR data for researchers in response to justified research requests;
- Addition of international medicines regulatory authorities as a new stakeholder group, which can obtain data on an ad-hoc basis;
- Increased emphasis on confidentiality of personal data to protect the identity of patients and reporters of ADRs, in accordance with EU data protection law.
Interested parties have until September 15, 2014 to send their comments on the draft policy to the agency.