EMA reforms EudraVigilance database access

Pharma companies have until 15 September to submit comments on the proposed changes

The European Medicines Agency (EMA) is consulting on proposed changes to rules governing access to its EudraVigilance database of suspected reported adverse reactions to authorised medicines. It receives more than one million adverse drug reaction (ADR) reports annually.

EMA wants to boost access to take account of recent EU pharmacovigilance reforms that increase transparency, the introduction of direct patient reporting, and the pharmaceutical industry's revised responsibility for monitoring EudraVigilance data for new safety issues, following a simplification of EU adverse reaction reporting rules.

An agency note highlighted some key planned changes:

  • Adding the World Health Organisation’s (WHO) Uppsala Monitoring Centre (UMC) as a group provided with weekly individual case safety reports;
  • Enhanced access of marketing-authorisation holders to reports related to their medicines;
  • Access to more detailed individual case safety data for researchers making justified research requests;
  • Allowing international medicines regulatory authorities to obtain data on an ad-hoc basis; and
  • Clarified guidance on the confidentiality of personal data to protect the identity of patients and adverse drug reaction reporters, following EU data protection laws.

The first EudraVigilance access policy came into force in 2011, with separate rules for regulators, healthcare professionals, consumers, patients, marketing authorisation holders and research organisations. The database is accessed online through this website.

A detailed EMA guidance paper commented: 'The aim is to provide the access necessary for those with legal obligations in pharmacovigilance and the highest possible degree of transparency while minimising the necessity to engage in ad-hoc reactive disclosure of information based on individual requests.'

Pharma companies have until 15 September to submit comments to evaccess@ema.europa.eu – see http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/08/WC500170699.pdf