European Commission drops infringement procedure against Roche

The European Commission says that it has closed the infringement procedure taken against Swiss pharma giant Roche (ROG: SIX) for failure to meet certain pharmacovigilance obligations.

The Commission explained that after considering all the available evidence and being satisfied with the company's remedial actions, it has decided to close the case. Further information is provided in the Commission’s statement. The Commission has now closed the case.

In a written statement submitted to the Commission, 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."