It was learned from the State Food and Drug Administration that the State Food and Drug Administration will increase the overseas production inspection of imported drugs. The State Food and Drug Administration said that the on-site inspection of imported drugs has become another important measure to maintain the safety of public drugs.
According to CCTV News on July 12, the State Food and Drug Administration said that according to the drug review and approval requirements, according to the port quality inspection and adverse reaction monitoring risk signals, the State Food and Drug Administration will promote the on-site inspection of imported drugs on an orderly basis. The intensity will continue to increase and the inspection efficiency will continue to increase. The number of inspection tasks will increase year by year. The inspection products will cover chemicals (sterile drugs, solid preparations, APIs, etc.), botanicals, biological products (blood products, vaccines, other therapeutics). Biological products, etc.) This year will also launch an overseas inspection of China's newly approved imported cervical cancer vaccine manufacturers.
In view of the problems found in the inspection, based on the principle of risk control, considering the nature of the problem, the severity and the conclusion of the inspection, the State Food and Drug Administration will eventually suspend the varieties of the varieties that have problems, and the varieties will not be re-registered. Suspension of review and approval, rectification within a time limit, and after assessment, determine whether to continue importing and other measures.
