State Food and Drug Administration: The quality and safety of selected drugs and medical devices in national centralized procurement is generally good

Xu Jinghe, deputy director of the State Food and Drug Administration, pointed out at the press conference on the series of "Authoritative Departments Talking about the Beginning" series of press conferences held by the State Council Information Office this morning. The special supervision of drugs and medical devices has realized the "three full coverage" of enterprise supervision and inspection, sampling inspection of products in production, and monitoring of adverse drug reactions (medical device adverse events) for the drugs and medical devices selected by the national centralized procurement. The inspections involved nearly 600 drug manufacturers and nearly 170 medical device manufacturers; product sampling involved 333 drug varieties and 15 medical device varieties, effectively guaranteeing the quality and safety of selected drugs and medical devices in centralized procurement. Comprehensively strengthen the implementation of the main responsibility of enterprises and the implementation of local regulatory responsibilities. From the perspective of supervision and inspection, supervision and random inspection, and adverse reaction (adverse event) monitoring, the quality and safety of selected drugs and medical devices in the national centralized procurement are in good condition.

In the next step, the State Food and Drug Administration will continue to increase the supervision of selected products in national centralized procurement, strengthen risk prevention and control, and comprehensively use supervision and inspection, sampling inspection, adverse reaction (adverse event) monitoring and other means to strengthen early warning of hidden risks, Early investigation and early treatment. In terms of drugs, provincial drug regulatory departments will be required to implement "one enterprise, one policy, one product, one file" for drug holders and manufacturers selected in centralized procurement, and further strengthen targeted supervision; in terms of medical devices, vascular stents, artificial joints and List management will be implemented for orthopedic and spine products and other nationally selected varieties in centralized procurement, and medical devices selected in national centralized procurement will be included in the national sampling inspection.