State Food and Drug Administration: Increase overseas inspections of imported drugs and devices
Release time：
2019-01-19
The reporter learned from the State Food and Drug Administration that the State Food and Drug Administration will increase the inspection of overseas production of imported drugs.
The State Food and Drug Administration stated that in accordance with the requirements of drug review and approval, and based on port quality inspection and adverse reaction monitoring risk signals, the State Food and Drug Administration will orderly promote the on-site inspection of imported drugs overseas production, and the inspection will continue to increase and the inspection efficiency will continue to improve . The number of inspection tasks will increase year by year, and the types of inspection will cover chemical drugs (sterile drugs, solid preparations, raw materials, etc.), herbal drugs, and biological products (blood products, vaccines, and other therapeutic biological products, etc.). This year will also launch overseas inspections of my country's newly approved manufacturers of imported cervical cancer vaccines.
For the problems found in the inspection, based on the principle of risk control, comprehensively considering the nature, severity and inspection conclusions of the problems, the State Food and Drug Administration will eventually suspend the import of the varieties with problems, refuse to re-register the varieties, and stop the varieties under review. Measures such as suspending review and approval, rectifying within a time limit, and determining whether to continue importing after evaluation.
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Jiangxi Hengkang Pharmaceutical Co., Ltd
TEL：18370075205
Address: No.1 Fenghuang West Avenue, Economic Development Zone, Shangrao City, Jiangxi Province
