EMA reports

The European Medicines Agency (EMA) has revised the EudraVigilance Access policy, which provides increased public access to reports on potential adverse reactions to medicines sanctioned in the European Union (EU).

The declaration came after an extensive public consultation, which resulted in more than 400 comments considered for the modifications in the final policy.

EudraVigilance Access policy is an European database of all the potential adverse reactions reported with medicines sanctioned to be available in the European Economic Area (EEA).

The revised policy considers the modifications made to the system of safety monitoring of medicines introduced by the pharmacovigilance legislation, which include new transparency requirements, introduction of direct patient reporting across all EU Member States, and simplifying the coverage of adverse reaction reports for pharmaceutical companies.

The major changes in the policy include more public access to information, such as listings of the side effect reports and summary presentations for individual adverse reaction reports received in EudraVigilance. The access, though transparent for medicine users, preserves the non-disclosure of the identity of the patients and of those who sent in the reports.

With the increased access, academicians will be able to gain support for their research requirements. A new stakeholder group, the Uppsala Monitoring Centre (UMC) of the World Health Organization (WHO) will be added. The UMC will be provided with individual case safety reports (ICSRs) that arise from within the EEA.

In countries out of the EEA bounds, medicines regulatory authorities will receive increased access to reports associated with their medicines in accordance with their signal detection and other pharmacovigilance compulsions.

The modifications are expected to take effect from the third quarter of 2017 when EMA plans to make a series of technical enhancements to the EudraVigilance system.

Image: EMA’s revised policy to make reports access more transparent. Photo: courtesy of Naypong/FreeDigitalPhotos.net.