EMA to investigate Roche's alleged non-compliance with pharmacovigilance

23 October 2012

The European Medicines Agency has started an infringement procedure against Swiss drug major Roche (ROG; SIX), following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

The initiation of the infringement procedure follows a pharmacovigilance inspection carried out in 2012 by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which identified serious shortcomings of Roche’s pharmacovigilance processes (The Pharma Letter June 22).

The start of this procedure means that the EMA will further investigate the allegations against Roche within the legal framework of Regulation (EC) No 658/2007. It does not prejudge the outcome of the investigation.

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