EMA finds problems in Roche's safety reporting system

EMA said it is working with national medicines agencies to investigate pharmacovigilance deficiencies at Roche (SIX:ROG; OTCQX:RHHBY). The agency said an inspection by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) found that Roche did not evaluate about 80,000 U.S. safety reports collected for its drugs and did not report them to health authorities. EMA is requiring Roche to submit a revised comprehensive action plan by June 27 to evaluate and report all outstanding cases. EMA said there is no evidence of a negative impact for patients while the investigation is ongoing. FDA said in a statement that it is working with EMA to assess the overall public health impact of these findings. ...