Europe Revises EudraVigilance Access Policy

The European Medicines Agency (EMA) has pledged to give increased access to reports on suspected adverse reactions to medicines authorized in the European Union (EU), while guaranteeing that personal data will be fully protected.

This initiative was adopted by EMA Management Board at its December 2015 meeting. The adoption followed a broad public consultation generating close to 400 comments, which have been taken into account in the final policy, according to EMA.

EudraVigilance is the European database of all suspected adverse reactions reported with medicines authorized 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 reports per year. The large datasets included in the database provide the backbone for the continuous safety monitoring of medicines in the EU.

The key changes include:

• The public will have access to more information, including line listings of the side effect reports and summary presentations for individual adverse reaction reports received in EudraVigilance. While ensuring that patients and those who have sent in reports of suspected side effects are not identifiable, this access represents a significant increase in transparency for the users of medicines, EMA claims.

• Academia will get extended access to datasets upon request in support of their research activities.

• The Uppsala Monitoring Centre (UMC) of the World Health Organization (WHO) will become a new stakeholder group, and will be provided with individual case safety reports originating from within the EEA.

• Regulatory authorities in countries outside the EEA will be provided with data, in line with the WHO dataset, upon request.

• Marketing authorization holders of medicines authorized in the EU will be given enhanced access to reports related to their medicines in support of their signal detection and other pharmacovigilance obligations.

These changes are due to come into effect in the third quarter of 2017 in parallel with the EMA implementing a series of technical improvements to the EudraVigilance system.

The data will be transferred electronically to WHO’s UMC on a daily basis, and the start of this data transfer in 2017 will follow the introduction of the new reporting rules within the EEA which take effect after a successful audit of the improved EudraVigilance system. The transferred reports on suspected adverse reactions occurring in the EEA will contribute to VigiBase, the WHO Global Individual Case Safety Report database, on behalf of the WHO Program on International Drug Monitoring.

Read the full release.