Pfizer injection for pneumonia is suspended

2014-01-02 source: due to the lack of application procedures, a fungal infection treatment injection of Pfizer, the world's largest pharmaceutical company, was urgently stopped The State Food and Drug Administration yesterday morning decided to suspend the import of fluconazole injection produced by Pfizer Pharmaceutical Co., Ltd until the company's rectification in place Fluconazole Injection, which began to enter the Chinese market in 2007, is suitable for the treatment of pneumonia, fungal infection and other diseases, with a large amount of clinical use "We have taken timely rectification measures and will continue to cooperate with the work of China food and drug administration The relevant issues do not involve the quality and safety of drugs and will not affect the drug safety of patients Relevant products in the Chinese market have been tested by relevant drug regulatory authorities and meet the standards of drug safety, efficacy and quality in China and internationally, "Pfizer China said in response to the incident on its website today According to the public information, the State Food and Drug Administration recently found in the overseas inspection of Pfizer drugs that Pfizer's Amboise factory in France failed to make relevant supplementary application in accordance with the requirements of Chinese laws and regulations during the production of Fluconazole Injection exported to China, which violated the relevant laws and regulations of China's drug regulation According to the relevant provisions of the State Food and drug administration, imported drug manufacturers must strictly implement the drug management laws and regulations of our country, strictly comply with the requirements of the overseas inspection and the Chinese Pharmacopoeia, especially the same technical requirements in different countries and regions shall not be different in implementation In case of non-compliance with Chinese laws and regulations, a series of strict regulatory measures shall be taken, including issuing warning information, stopping sales and import