EMA giving increased access to reports on suspected adverse reactions on medicines authorised in EU
The EMA will give increased access to reports on suspected adverse reactions to medicines authorised in the European Union, while guaranteeing that personal data will be fully protected.
This results from a revision of Eudra Vigilance Access policy adopted by EMA’s Management Board in Dec. 2015 meeting. This followed on from a broad public consultation which had nearly 400 comments that were taken into account in the final policy.
EudraVigilance is a European database for all suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA). Managed by 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 backbone for the continuous safety monitoring of medicines in the EU. …. More