药品监管

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轮台县市场监管局开展校园“药品安全小课堂”
Zhong Guo Shi Pin Wang· 2025-09-12 04:23
"家庭小药箱整理技巧是什么?""处方药与非处方药的区别?"互动区的"用药情景模拟"引发热烈讨论。 执法人员结合真实案例,讲解重复用药的危害,还教大家用手机扫描药品追溯码查询真伪。学生们纷纷 掏出笔记本,记下"用药前看生产日期、用法用量要遵说明"等要点。 近日,轮台县市场监督管理局为筑牢青少年药品安全防线,走进第六小学开展"安全用药进校园"主题宣 传活动,为师生送上生动实用的"药品安全课"。 活动中,执法人员化身"安全导师",通过卡通动画、情景短剧等青少年喜闻乐见的形式,解析"网红 药""海淘药"的潜在风险,演示如何识别过期药品和虚假药械广告。针对学生群体常见的感冒、过敏等 用药场景,现场发放《药品安全宣传册》,用案例讲解 "遵医嘱、看说明、拒滥用" 的用药原则,引导 大家建立科学用药意识。 下一步,轮台县市场监管局将持续推进"药品安全进校园"常态化,通过"小手拉大手"带动家庭、辐射社 会,共同构筑药品安全"防护网"。(通讯员:陈婧,审稿人:冉兵) ...
国家药监局局长李利会见新加坡卫生科学局局长蔡瑞文
Zheng Quan Shi Bao Wang· 2025-09-10 11:28
人民财讯9月10日电,9月10日,国家药监局局长李利在京会见了来访的新加坡卫生科学局局长蔡瑞文一 行。双方围绕推动中新两国药品和医疗器械监管互信、中药监管等内容进行交流。双方同意,进一步深 化药品监管领域务实合作,共同提升药品监管质效,更好增进两国人民健康福祉。 ...
国家药监局:科学制定“十五五”药品规划 全面深化药品审评审批制度改革
Zhong Zheng Wang· 2025-08-29 03:24
Core Viewpoint - The National Medical Products Administration emphasizes the importance of formulating the "14th Five-Year" drug planning to enhance drug regulation capabilities and promote high-quality development of the pharmaceutical industry, aiming to transition China from a major pharmaceutical country to a strong pharmaceutical nation [1] Group 1: Drug Regulation Development - The meeting highlighted the need to develop an overall strategy for drug regulation during the "14th Five-Year" period [1] - It aims to address deep-seated contradictions and issues in drug regulation, enhancing governance capabilities [1] - The focus is on creating a comprehensive drug safety responsibility system and a full-chain regulatory mechanism [1] Group 2: Reform and Innovation - There is a call for comprehensive deepening of drug review and approval system reforms [1] - The meeting encourages the innovation and development of traditional Chinese medicine and high-end medical devices [1] - It also emphasizes the need to reform the review and approval mechanisms for cosmetics to promote high-quality development [1] Group 3: Regulatory Capacity Building - The meeting stresses the importance of improving the regulatory standards and legal framework [1] - It highlights the need for strengthening technical support capabilities and leading with information technology [1] - The goal is to build a high-quality team of drug regulatory professionals to enhance overall regulatory capabilities [1]
美国食品药品监督管理局(FDA)拟任命生物技术高管马卡里担任首席药品监管官。
news flash· 2025-07-21 10:13
Core Viewpoint - The FDA is planning to appoint biotechnology executive Macari as the Chief Drug Regulator [1] Group 1 - The appointment of Macari is expected to influence drug regulation policies and practices within the FDA [1] - Macari's background in biotechnology may bring a new perspective to the FDA's approach to drug approvals and oversight [1] - This move reflects the FDA's ongoing efforts to enhance its regulatory framework in response to the evolving pharmaceutical landscape [1]
速递|打击中国减肥药?FDA将对所有进口商品进行筛查
GLP1减重宝典· 2025-07-18 04:15
Core Viewpoint - The FDA has announced a new regulation that requires all imported products to undergo review, regardless of their value or size, following the cancellation of the small package exemption policy [2][3][4]. Group 1: Regulatory Changes - The previous exemption for products valued under $800 has been eliminated, meaning all products will now be subject to full review [3]. - This policy took effect on July 9 and aims to enhance the FDA's oversight of the U.S. supply chain and improve the identification of repeat violators [4]. - The new regulation applies to all product categories regulated by the FDA, including drugs, food, beverages, dietary supplements, cosmetics, medical devices, and biological samples [6]. Group 2: Impact on Imports - The FDA can now review all imported products declared through electronic systems, including those purchased online and transported across borders [5]. - Even small packages must adhere to the same regulatory standards as larger shipments, which may affect the circulation of weight-loss drugs in the "gray market" [8]. - A study indicated that in January, shipments of active ingredients from unregistered Chinese suppliers increased by 44% compared to the previous month [8]. Group 3: Implications of the Policy - The data does not account for packages that previously entered the U.S. under the exemption policy, suggesting that the actual import volume may be significantly higher than current statistics indicate [9]. - This policy adjustment is part of the FDA's efforts to close regulatory loopholes and strengthen comprehensive import reviews [10].
据华尔街日报:美国食品药品监督管理局(FDA)重新调整药品审批流程,包括加快部分药物的审批速度以及增加人工智能的应用。
news flash· 2025-06-17 09:04
Core Insights - The FDA is revising its drug approval process to accelerate the approval speed of certain medications and increase the application of artificial intelligence [1] Group 1 - The FDA's adjustments aim to enhance the efficiency of drug approvals [1] - The incorporation of artificial intelligence is expected to streamline the evaluation process for new drugs [1]