LONDON, April 14 The European Medicines Agency
(EMA) said on Monday it had concluded an inquiry into lax
drug-safety reporting at Roche and sent its report to
the European Commission for the next steps.
The European Commission will decide whether the matter
should be pursued and financial penalties should be imposed.
The process could potentially lead to hefty fines for the
Swiss drugmaker for breaching EU rules but the agency gave no
further details on its conclusions because the procedure is
The EMA previously said in November it had not uncovered any
new safety issues connected with Roche's drugs as a result of
the shortcomings in reporting adverse events.
EMA launched its probe into Roche in 2012 after a routine
inspection found the firm had failed to properly assess tens of
thousands of cases of possible adverse drug reactions, involving
19 drugs, several of which were for cancer.
Drugmakers are required to evaluate problems reported by
doctors and patients after taking their drugs and then pass on
any serious cases to regulators. The inspection found many of
these reports had not been properly assessed by the company.
Roche could face fines for failing to comply with so-called
"pharmacovigilance" obligations under EU rules of up to 5
percent of its annual EU turnover, which totalled 12.8 billion
Swiss francs ($14.6 billion) in 2011.
($1=0.8791 Swiss francs)
(Reporting by Ben Hirschler; Editing by Greg Mahlich)