LONDON: The European Medicines Agency has started an infringement procedure against pharmaceutical giant Roche for allegedly failing to properly report side effects in patients in the U.S.
European authorities identified the problem in May after noticing "serious shortcomings" in how Roche AG reported potential side effects. Regulators said about 80,000 reports by consumers of possible adverse effects to drugs sold in the U.S. had not been properly analyzed. They said there was no evidence patients were at risk.
In a statement on Tuesday, the European Medicines Agency says it will further investigate the allegations against Roche. Their report will be passed to the European Commission, which may impose penalty fines if Roche is found to have committed an infringement of its obligations to report side effects.