EMA concludes drug monitoring probe against Roche

The European Medicines Agency (EMA) announced yesterday that it has concluded its second inquiry in its case against pharmaceutical company Roche centring on the company’s pharmacovigilance duties.

The procedure is investigating allegations that Roche “failed to comply with its pharmacovigilance obligations” in relation to 19 of its authorised products.

Pharmacovigilance is the practice of monitoring the effects of drugs after they have been licensed for use in case previously unreported adverse reactions are discovered.

The EMA’s filing followed an inspection carried out by the UK Medicines and Healthcare Products Regulatory Agency in 2012 that identified shortcomings in Roche’s pharmacovigilance processes.

An inquiry was finalised by the EMA in April 2014 and sent to the European Commission.

In July last year the commission returned the file to EMA for a new period of inquiry and for further examination of certain points.

The EMA  sent its second inquiry on July 1.

A spokesman for Roche said it had received the final updated report and that the commission was currently reviewing it.