The European Medicines Agency (EMA) is investigating Roche’s drug safety reporting system after an inspection by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) found deficiencies in the Swiss drugmaker’s reporting process.
At the time of the MHRA inspection, Roche identified about 80,000 reports for medicines marketed by the company in the U.S. that had been collected through a Roche-sponsored patient support program. However, these reports had not been evaluated to determine if they should be reported as suspected adverse reactions to the European Union authorities, according to an EMA press release. These included 15,161 reports of patient deaths, but it is not known whether the deaths were due to the drugs involved or the natural progression of a disease.
Other deficiencies identified by the MHRA related to the evaluation and reporting by Roche to national regulators of suspected adverse reactions from their reporting systems - around 23,000 - and clinical trials - around 600.
The EMA stated that it continues to work closely with the national medicines agencies and the U.S. Food and Drug Administration, as well as other international partners, to assess the overall public health impact of the findings, including any consequences for the overall benefit-risk balance of the drugs.
"Patients should continue to take their medicines because our investigation into Roche has currently found no evidence of a safety risk to patients,” said the MHRA in a statement.
Roche say the non-reporting was not intentional and that it is committed to taking corrective action to address the issue, according to Reuters.
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