European Commission closes Roche investigation
The European Commission has closed an investigation into Roche which centred on the company’s pharmacovigilance duties.
“Pharmacovigilance activities are a core part of the activities of a marketing authorisation holder to monitor the continuous safety of medicinal products that have been placed on the market,” said the Commission.
On Friday, December 15, the Commission explained that after considering all the available evidence and being satisfied with Roche’s remedial actions, it decided to close the case.
The procedure began in October 2012, after an inspection carried out by the UK Medicines and Healthcare Products Regulatory Agency identified “serious shortcomings” in Roche’s pharmacovigilance processes.
The Commission then requested that the European Medicines Agency (EMA) investigate allegations that Roche had failed to meet its pharmacovigilance obligations for 19 of its authorised medicines.
In 2014, the initial EMA investigation report was finalised and forwarded to Roche and the Commission.
The following year, the Commission returned the file to the EMA for an additional enquiry and for further examination of certain facts.
In July last year, the EMA concluded its second enquiry in its case against Roche.
The EMA’s final report was sent to the Commission, which has now closed the infringement procedure taken against Roche.
According to the Commission’s statement, the measures that Roche has implemented provide sufficient assurances that the findings should not occur again in the future.
Roche said that it had taken all of the findings very seriously and fully understood the EMA’s and Commission’s concerns.
The pharmaceutical company said it has worked “diligently to remediate the deficiencies as quickly as possible and also to enhance the company’s medical compliance and pharmacovigilance systems to prevent any recurrence”.
Roche added that its efforts to improve its systems and to maintain the trust of all stakeholders must continue.
Roche said it was committed to working with the authorities to ensure it “becomes, and then remains, a leader in the field”.
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