State Food and Drug Administration: Increase the intensity of overseas inspection of imported pharmaceutical equipment

Medical Network July 13th According to the State Food and Drug Administration, 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 drug Review and approval requirements, based on port quality inspection and Adverse reactions Monitoring the risk signal, the State Food and Drug Administration will promote the on-site inspection of imported drugs overseas in an orderly manner. The inspection will continue to increase and the inspection efficiency will continue to increase. The number of inspection tasks will increase year by year. The inspection varieties will cover chemicals (sterile drugs, solids). Preparations, APIs, botanicals, biological products (blood products, vaccines, other therapeutic biological products, etc.) This year will also launch the newly approved imported cervical cancer vaccine production in China. enterprise Overseas inspection.

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.