EMA Finishes Second Inquiry on Roche’s Pharmacovigilance

The European Medicines Agency has finished its second inquiry into Roche’s alleged non-compliance with pharmacovigilance obligations, identifying no new safety concerns in its latest review.

The infringement procedure was launched in October over accusations that the Swiss drug giant failed to comply with pharmacovigilance obligations related to 19 of its EU-approved products. This followed an investigation by the UK’s Medicines and Healthcare products Regulatory Agency, which identified serious shortcomings in Roche’s pharmacovigilance processes.

The European Commission ultimately will make a final determination on whether to pursue the matter further and impose financial penalties.