Infringement Procedure Against Roche Closed by EU

On Dec. 15, 2017, the European Commission (EC) announced it has closed its infringement case against Roche after the company successfully completed remedial actions to address pharmacovigilance concerns. The infringement procedure began in October 2012 by the European Medicines Agency (EMA) to investigate allegations that Roche had failed to comply with pharmacovigilance regulations. These allegations came after a 2012 inspection by the UK Medicines and Healthcare products Regulatory Agency found process deficiencies at Roche.

EMA’s investigation was completed in April 2014. The EC continued the infringement procedure, and in July 2015, the EC asked EMA to do additional examination. EMA’s final report was presented to the EC in July 2016.

In a written statement to the EC, Roche said, “Roche accepted all the inspection findings. It took them extremely seriously and fully understands the EMA’s and Commission’s concerns. It has worked diligently to remediate the deficiencies as quickly as possible and also to enhance the company’s medical compliance and PV systems to prevent any recurrence. While it has come a long way, the company knows that its efforts to enhance its systems and to maintain the trust of all stakeholders must continue. It is committed to working with the authorities to ensure it becomes, and then remains, a leader in the field."

Source: EMA