Updated on 22 June 2012
Singapore: The European Medicines Agency is working with national medicines agencies to investigate deficiencies in the medicine-safety reporting system of Roche. This includes looking at whether the deficiencies have an impact on the overall benefit-risk profile for any of the products involved.
There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action.
The deficiencies are identified in a May 2012 report from the UK medicines regulatory agency (MHRA) following an inspection at Roche. This was part of a coordinated European programme of routine inspection of safety reporting systems.
At the time of the inspection the company identified some 80,000 reports for medicines marketed by Roche in the USA that had been collected through a Roche-sponsored patient support programme, but which had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities. These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine. More recent information from the company indicates a smaller number of reports, but this information needs to be verified by the authorities.
It remains unclear whether any of the reports have already been submitted to the EU authorities through other channels, for example by the treating healthcare professionals. Other deficiencies identified related to the evaluation and reporting to national medicines agencies of suspected adverse reactions from their reporting systems (around 23,000) and clinical trials (around 600).