EMA investigating deficiencies in Roche's drug safety reporting
The European Medicines Agency revealed yesterday that it is working with national medicines agencies to investigate deficiencies in the medicine safety reporting system of Swiss drug major Roche (ROG: SIX), the world’s biggest producer of cancer drugs.
The EMA says this includes looking at whether the deficiencies have an impact on the overall benefit-risk profile for any of the products involved. However, it points out that 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 health care professionals to take any action.
The deficiencies were identified in a May 2012 report from the UK Medicines and Healthcare products Regulatory Agency (MHRA) following an inspection at Roche. This was part of a coordinated European program of routine inspection of safety reporting systems.
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