The State Food and Drug Administration (SFDA) said Thursday that it has debriefed a manager supervising product security at Roche China, following an investigation into possible adverse reactions of some Roche products.
The SFDA said in a statement that it has closely followed the development of a European Medicines Agency investigation that revealed that the Swiss pharmaceutical company failed to report adverse reactions to some of its drugs. About 15,000 patient deaths might be linked to the reactions.
The SFDA has asked the company to issue a report on safety evaluations for the medications, the statement said.
The SFDA has contacted the World Health Organization and the U.S. Food and Drug Administration for further information about the evaluations, the statement said.
Roche China confirmed Thursday that six of the eight medications, which are used to treat cancers and a liver disease, involved in the investigation are sold in China, instead of five, as the SFDA said in a statement Tuesday.
The company said there has been no impact on the safety of its products based on current assessments.
On Tuesday, the SFDA said it would increase monitoring of the drugs, adding that its network has not yet reported any abnormal cases related to their use.
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