EMA launches formal inquiry into Roche pharmacovigilance issues

The European Commission may impose fines or periodic penalty payments on Roche (SIX:ROG; OTCQX:RHHBY) if EMA finds that the pharma violated EU pharmacovigilance regulations by failing to report potential adverse events to health authorities. On Tuesday, EMA launched a formal investigation into June allegations by U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) that Roche did not evaluate about 80,000 U.S. safety reports collected for its drugs and did not report them to health authorities. EC requested the investigation (see BioCentury Extra, June 21). ...