【省药监局】陕西强化“两品一械”监管

Core Insights - In 2025, Shaanxi aims to enhance law enforcement collaboration across provincial and municipal levels, targeting 2,678 cases related to "two products and one device" (drugs, cosmetics, and medical devices) and transferring 56 cases to judicial authorities [1] Group 1: Regulatory Focus - Shaanxi's regulatory efforts have concentrated on high-risk enterprises, high-risk products, and critical production processes, ensuring compliance with drug quality management standards [1] - The province has implemented a "rectification follow-up" mechanism to track the compliance of enterprises with corrective actions [1] Group 2: Online Sales Regulation - To address challenges posed by online drug sales, Shaanxi has strengthened integrated supervision of online and offline sales, emphasizing corporate responsibility [1] - The province is focusing on cracking down on illegal online drug sales, including unqualified sales and prescription drugs sold without prescriptions [1] Group 3: Regulatory Efficiency - Shaanxi is promoting service-oriented law enforcement in drug regulation, allowing for leniency in minor violations through a "first violation not penalized" list [1] - The province is also piloting reforms to optimize the review and approval process for supplementary drug applications [1] Group 4: Future Initiatives - Shaanxi plans to enhance high-level regulation throughout the drug lifecycle, continuing initiatives such as the "clean source" action in drug operations and a three-year improvement plan for cosmetic production quality management systems [2]