药品监管

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【省药监局】陕西加强药品经营使用监督管理
Shan Xi Ri Bao· 2025-07-06 23:31
Core Viewpoint - The Shaanxi Provincial Drug Administration has released a plan for drug supervision and management for 2025, emphasizing the need to strengthen regulation in key varieties, links, enterprises, and regions to ensure drug quality and safety [1][2] Group 1: Regulatory Actions - Shaanxi will implement the "Qingyuan" action, focusing on drug wholesale and retail enterprises, as well as online sales, to combat illegal drug purchasing and selling channels [1] - The province aims to enhance the traceability system for drug operations, ensuring comprehensive coverage of five categories of drugs through QR code tracking [1] Group 2: Quality Supervision - Increased regulatory efforts will be directed towards vaccines, blood products, and commonly used high-value drugs, with special inspections for traditional Chinese medicine (TCM) products [1] - There will be a focus on prescription drugs and chronic disease medications, particularly in monitoring procurement channels, storage management, and information traceability [1] Group 3: Targeted Inspections - The Shaanxi Provincial Drug Administration will strengthen oversight of illegal sales of TCM formula granules and prescription drugs without proper prescriptions, as well as the absence of licensed pharmacists [2] - Special attention will be given to rural areas and small pharmacies, ensuring they have established quality management systems for drug procurement, acceptance, and storage [2] - Investigations will target issues such as substandard storage conditions and the illegal sale of TCM products, including the sale of inferior or counterfeit goods [2]
国家药监局:强化肉毒素监管 严防流入非法渠道
news flash· 2025-07-03 09:36
Core Viewpoint - The National Medical Products Administration (NMPA) is enhancing the regulation of botulinum toxin to prevent its illegal distribution, responding to recent media exposure of issues related to unregulated medical beauty training and injection practices [1] Regulatory Actions - The NMPA has established a national drug traceability supervision system to monitor the distribution of botulinum toxin products and promptly alert risks [1] - The regulatory body emphasizes the importance of public medication safety and is committed to strengthening the oversight of drug quality and safety [1] Enforcement Measures - The NMPA plans to continue its efforts in addressing illegal activities related to drug use and will collaborate with law enforcement agencies to combat crime [1] - The focus is on ensuring the safety and health of the public regarding medication use [1]
美国白宫:美国总统特朗普已下令美国食品药品监督管理局(FDA)加强对外国药品生产商主动药用原料来源报告的执法力度,并考虑公开展示不合规药厂的名单。
news flash· 2025-05-05 20:54
Core Viewpoint - The U.S. government, under President Trump, has directed the FDA to enhance enforcement regarding the reporting of active pharmaceutical ingredient sources by foreign drug manufacturers and is considering publicly listing non-compliant drug manufacturers [1] Group 1 - The FDA will increase its enforcement actions against foreign pharmaceutical manufacturers [1] - There is a potential plan to publicly disclose a list of non-compliant drug manufacturers [1]
涉嫌使用“回流药”,武汉5家涉案医疗机构和人员已被立案调查 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-03-30 23:37
Group 1 - Five medical institutions and personnel in Wuhan have been investigated for allegedly using "reflow drugs," with the local medical insurance bureau suspending their insurance settlements and service agreements [1] - The Wuhan market supervision department will conduct a special rectification of pharmacies across the city, while the police have detained several drug dealers involved in the case [1] Group 2 - Eli Lilly's innovative drug for Alzheimer's disease, "Jinengda" (donanemab injection), has officially launched in China, targeting early-stage Alzheimer's and significantly slowing disease progression [2] - "Jinengda" was approved by the National Medical Products Administration on December 17, 2024, as a breakthrough therapy for treating mild cognitive impairment and mild dementia due to Alzheimer's disease [2] Group 3 - Heng Rui Medicine reported a 2024 net profit of 6.337 billion yuan, a year-on-year increase of 47.28%, with total revenue reaching 27.985 billion yuan, up 22.63% [3] - The company plans to distribute a cash dividend of 2 yuan per 10 shares (including tax), driven by significant growth in innovative drug revenue and successful overseas licensing [3] Group 4 - Hua Lan Biology disclosed a 2024 net profit of 1.088 billion yuan, down 26.57% year-on-year, with total revenue of 4.379 billion yuan, a decrease of 18.02% [4] - The company continues to upgrade production processes for existing blood products and increase investment in vaccine, innovative drug, and biosimilar development [4]