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广东省药品监督管理局关于药品质量抽查检验结果的通告(2025年第10期)
Xin Lang Cai Jing· 2026-01-05 08:24
为加强药品质量监管,保障公众用药安全,根据广东省药品抽检计划,广东省药品监督管理局组织对全省药品生产、经营、使用环节进行药品质量抽查检 验,现将药品质量抽查检验结果予以通告(见附件1)。 广东省药品监督管理局要求相关地市药品监督管理部门依据《中华人民共和国药品管理法》,组织对相关企业和单位存在的涉嫌违法行为立案调查,并按规 定公开查处结果。 对抽查检验不符合规定药品,药品监督管理部门已要求相关企业和单位采取暂停销售使用、召回等风险控制措施,对不符合规定原因开展调查并切实进行整 改。 ...
黄果在北京调研集采中选药品质量监管工作
Xin Lang Cai Jing· 2025-11-18 09:52
Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of ensuring the quality and safety of drugs selected through centralized procurement, highlighting the need for strict compliance and quality control by selected companies [1] Group 1: Regulatory Oversight - The NMPA will implement comprehensive production inspections and product sampling for selected drugs, ensuring full coverage in regulatory practices [1] - Regulatory bodies will optimize work mechanisms and explore risk monitoring to enhance oversight and prevent potential risks [1] Group 2: Company Responsibilities - Selected companies are required to strictly fulfill their primary responsibilities, focusing on quality control, drug vigilance, and information traceability [1] - Continuous compliance in production practices is mandated for companies involved in centralized procurement [1]
内蒙古各地有序开展药品经营环节“清源”行动
Nei Meng Gu Ri Bao· 2025-07-25 12:50
Core Viewpoint - Inner Mongolia has launched a comprehensive "Clearing Source" action to regulate drug distribution and enhance drug quality supervision, aiming to combat illegal activities in the pharmaceutical sector and ensure public safety in medication [1][2]. Group 1: Regulatory Actions - The Baotou Market Supervision Bureau has initiated the "Clearing Source" action from April to November, targeting illegal activities such as renting out licenses, manufacturing and selling counterfeit drugs, and selling prescription drugs without prescriptions [1]. - The Tongliao Market Supervision Bureau has implemented a "cloud supervision" system using facial recognition and GPS to monitor the on-duty status of licensed pharmacists in pharmacies, with 690 pharmacists already registered on the platform [1]. - The Xilin Gol League Market Supervision Bureau is focusing on retail drug enterprises and medical beauty clinics, inspecting for the sale of unapproved drugs and illegal procurement channels, having checked 123 retail drug enterprises and 13 other medical institutions [1]. Group 2: Focus Areas and Measures - The Ordos Market Supervision Bureau is conducting inspections on special drugs, centrally procured drugs, and Mongolian medicine formulations, particularly at major medical institutions [1]. - The Ulaanbaatar Market Supervision Bureau is focusing on potential risks in the drug distribution sector, including abnormal price fluctuations and procurement channels, while ensuring prescription drugs are sold strictly with prescriptions [2]. - The Alxa League regulatory departments are emphasizing inspections in rural areas and focusing on high-value drugs and special compound preparations, enhancing quality management in retail chain stores [2].
广州市监局部署开展药品经营环节“清源”行动
news flash· 2025-06-06 07:13
Core Viewpoint - The Guangzhou Market Supervision Administration has launched a "Clearing Source" action to regulate drug business practices and enhance drug quality supervision across the city [1] Group 1: Action Focus - The action targets issues such as the rental and lending of licenses, production and sale of counterfeit drugs, illegal drug purchases, and the sale of prescription drugs without prescriptions [1] - A leadership team has been established to oversee the "Clearing Source" action, with the Drug and Chemical Department leading the development of the action plan [1] Group 2: Responsibilities and Compliance - The action aims to reinforce the primary responsibility of drug operating enterprises and users, urging them to conduct self-inspections across all drug procurement, sales, storage, and usage stages [1] - Special attention will be given to wholesale enterprises, retail chain headquarters, and retail enterprises that engage in abnormally low-priced drug procurement [1] Group 3: Risk Management and Enforcement - The initiative will strengthen the approval and entry mechanisms, optimize the exit mechanisms, and enhance the management of retail chain enterprises [1] - Comprehensive checks will be conducted on enterprises with a history of complaints, multiple referrals, and inadequate rectifications, including online and offline inspections [1] - The action will involve collaboration with public security, health, and medical insurance departments to thoroughly investigate potential illegal activities and enforce strict penalties for violations [1]