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MHRA statement on investigation into Roche


21 June 2012

The MHRA have issued the following statement in response the European Medicines Agency’s update on Roche’s medicine-safety reporting system.

Prof Sir Kent Woods, Chief Executive of the MHRA, said:

"Patients should continue to take their medicines because our investigation into Roche has currently found no evidence of a safety risk to patients.

“Roche’s actions are unacceptable and our investigation has identified that Roche’s reporting systems are inadequate. We are taking urgent action to ensure that these are rectified by Roche as a matter of priority.

“We, alongside the European Medicines Agency and other regulators, will take action to ensure that patients are protected now and in the future.”


Page last modified: 21 June 2012