药品质量监管
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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
11月18日,国家药监局党组成员、副局长黄果在北京市调研集采中选药品质量监管工作,实地走访华润 双鹤药业股份有限公司,调研企业质量管理及地方药品监管部门监管情况。黄果强调,要充分认识保障 集采中选药品质量安全的重要性,中选企业要严格落实主体责任,加强质量控制、药物警戒和信息化追 溯等工作,持续合规生产;监管部门将继续实行中选药品生产检查和产品抽检两个"全覆盖",并不断优 化工作机制,探索开展风险监测等工作,前移监管触角,防范化解风险,坚决查处违法违规生产经营行 为。 ...
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]