【省药监局】陕西实现药品、疫苗、医疗器械、化妆品监管全覆盖

Core Viewpoint - Since the beginning of the 14th Five-Year Plan, Shaanxi's drug regulatory system has effectively implemented reforms in drug safety risk prevention and control, aiming for comprehensive regulation of drugs, vaccines, medical devices, and cosmetics by the end of 2025 [1][2] Group 1: Regulatory Reforms - The Shaanxi drug regulatory system has established an integrated operational mechanism to enhance regulatory capabilities, ensuring clear functions and smooth operations of regulatory agencies [1] - The implementation of party and government responsibilities in drug regulation has been effectively carried out, with a well-established food and drug safety committee mechanism at provincial, municipal, and county levels [1] Group 2: Support for Industry Development - Continuous reforms in the review and approval system have supported the high-quality development of the "two products and one device" (drugs, cosmetics, medical devices) industry [1] - The approval of the first Class I innovative drug, Mesylate Prefofovir Tablets, marks a breakthrough for Shaanxi in Class I innovative drugs [1] - Five Class III innovative medical devices have been approved for market entry, and two new cosmetic raw materials have been filed with the National Medical Products Administration [1] - A total of 196 drug varieties have passed or been deemed to have passed the consistency evaluation of generic drugs [1] Group 3: Smart Regulation Initiatives - Shaanxi has established a comprehensive drug regulatory business system and a vaccine (drug) traceability regulatory system, achieving a "one network" operation for drug and device regulation across provincial, municipal, and county levels [2] - Key drugs such as vaccines, special drugs, blood products, and selected products from centralized procurement have achieved full-chain traceability [2] - The integration and sharing of various regulatory information have enabled closed-loop management for risk identification, warning, and response [2]