07 Jan 2014, BioSpectrum Bureau , BioSpectrum
Singapore: The China Food and Drug Administration (CFDA) has suspended the import of a drug manufactured by the US drug maker Pfizer. The CFDA said that the company did not file documents in accordance with the Chinese law.
Chinese news reports said that the suspended drug is an anti-fungal Fluconazole injection. Meanwhile, reacting to the same, the company issued a statement on its official website clarifying its stance. The official statement said that during a regular examination of overseas drugs, the CFDA had found that one of Pfizer's French factories had failed to submit a supplementary document on time.
The company clarified that the suspension had not been caused by the drug's quality and safety. It said the France-based factory has now submitted the required document and is expected to be granted approval soon.
Pfizer added that only the import of the injection had been temporarily halted and not its sales. Sales of the drug in the Chinese market have remained unaffected, it said.
The CFDA, in its announcement said that it had begun examining other drugs imported to China. Earlier in December, the CFDA had said in a statement that 25 imported drugs from foreign drug makers, including Pfizer, GlaxoSmithKline and Roche would be examined by the regulator at their production sites, starting from 2014.