SFDA Steps Up New Drug Approval For H1N1 Flu
This article was originally published in PharmAsia News
Executive SummaryChina's State FDA has identified concrete measures against the influenza A (H1N1) virus. The agency will: (1) set up an expert panel in charge of H1N1 flu drug evaluation and approval to gear up for early R&D involvement and rapid approval of resultant drugs; (2) coordinate departments on new drug acceptance, examination and testing to prepare for special procedures of H1N1 flu drug approval; (3) pay close attention to R&D of Class-I new drugs of neuraminidase inhibitors; (4) survey the nation's flu drugs and medical devices by conducting on-site inspections of relevant pharmaceutical companies' production plans and capacities; and (5) demand drug administration departments enhance supervision of drug and medical device quality for H1N1 flu. (Click here for more - Chinese language
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