Regulators Probe Roche's Drug-Safety Reporting

Severin Schwan, Roche CEO 

The European Medicines Agency (EMA), which is Europe's drug regulatory authority has stated that it will investigate Roche Holding AG after it found that Roche had failed to properly evaluate approximately 80,000 cases.  Patient deaths were reported in  15,161 of these cases.

Roche has indicated that it did not comply with regulations for the reporting of safety events.  Roche stated that "the company is working closely with health authorities, including the European Medicines Agency, to implement these measures in due time."