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暖新更“暖心”新疆沙湾市市监局前置监管为新开办口腔诊所筑牢药械安全防线
Zhong Guo Shi Pin Wang· 2025-12-18 03:52
(通讯员 韩剑报道)为从源头拧紧口腔诊所药械质量安全阀,新疆沙湾市市监局主动靠前发力,精准 聚焦仅取得营业执照、尚未完成医疗机构备案、且未购进药品医疗器械的新开办口腔诊所,把监管服务 送到"起跑线"上,从起步阶段帮诊所夯实药械质量安全管理基础。执法人员将服务关口前移,围绕口腔 诊所常用的定制式义齿、牙科种植体、正畸材料、消毒器械等核心器械,逐项讲解药械采购验收、储存 养护、台账记录等关键环节,现场演示核验供货商资质、产品注册证等材料的核验流程,确保药械来源 可溯,去向可追。同时,执法人员送上"普法大礼包",结合典型案例解读违规使用药械的法律后果,以 案说法敲警钟,提醒诊所树立"合规先行"的经营理念,守牢药械使用安全底线。 此次前置监管,新疆沙湾市市监局变"事后处罚"为"事前帮扶",即为新开办口腔诊所筑牢药械使用安全 防线,也让市场主体感受到了监管的"力度"与"温度"。下一步,新疆沙湾市市监局将持续深化"放管 服",把前置指导服务延伸到更多医疗相关邻域,用精准监管和暖心服务,守牢群众就医用药用械质量 安全。 ...
李家超:于2026年内成立“香港药物及医疗器械监督管理中心”
Core Points - The Hong Kong government plans to establish the "Hong Kong Drug and Medical Device Regulatory Center" by 2026 to become an internationally recognized authority in drug and medical device regulation [1] - The government will accelerate the "1+" new drug approval mechanism, prioritizing the approval of innovative drugs that can treat serious or rare diseases as recommended by the Hospital Authority [1] - Hong Kong aims to standardize clinical data within the Greater Bay Area and build a real-world data platform to facilitate faster market access for innovative drugs to mainland China and international markets [1]
组织市民走进药企考察,北京“药品安全宣传周”系列宣传活动启动
Xin Jing Bao· 2025-09-02 06:09
Group 1 - The "National Drug Safety Publicity Week" will be held from September 1 to 7, 2025, with a series of themed promotional activities organized by the Beijing Drug Administration [1] - Activities will include laboratory open days, public open days, and services delivered to parks and enterprises, aimed at showcasing drug regulation achievements and promoting safety knowledge of drugs, cosmetics, and medical devices [1] - The initiative will involve cross-regional collaboration in the Beijing-Tianjin-Hebei biopharmaceutical sector, exploring innovative regulatory models and hosting national laboratory open day events [1] Group 2 - The "Pharmacist Walks with You" initiative will conduct public lectures in commercial areas and communities, addressing medication safety and management [2] - Over the past five years, Beijing has conducted an average of 13,000 batch inspections annually for drugs, medical devices, and cosmetics, maintaining a drug inspection pass rate of over 99.8% [2] - The "Risk + Credit" classification and grading regulatory system has been upgraded, evaluating 47,000 regulatory entities and identifying over 300 potential risk points [2] Group 3 - Pilot policies for innovative drug clinical review and approval, as well as segmented production of biological products, have been implemented in Beijing [3] - In the innovative drug clinical review pilot, 12 projects have been approved for clinical trials, with the fastest approval taking 18 working days [3] - A green channel for urgently needed imported drugs and devices has been established, benefiting approximately 4,900 patients through the approval of 25 temporary import drug specifications [3]