BEIJING — China has banned the import of three medicines from two British companies, according to a statement on the website of the China Food and Drug Administration (CFDA).
The CFDA found Calcium Sulphate and Synthetic Resorbable Bone Graft were registered independently in China, but the two medicines were sold in a collective package with unregistered injector and water for injection, which violated the registration regulation of medical instruments in China.
Both medicines were produced by Biocomposites Ltd and used in orthopedic surgery.
The CFDA also found Leica Biosystems Newcastle Ltd changed the major raw material suppliers for its HER-2 reagent, but the company did not report the change, which violated in vitro reagent management in China.
The HER-2 reagent was used to identify breast cancer.