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国家药监局:开展药品经营环节“清源”巩固提升行动 持续健全药品监管法律法规体系
Di Yi Cai Jing· 2026-01-07 10:38
1月6日至7日,全国药品监督管理工作会议在北京召开。会议强调,2026年要围绕实现"十五五"良好开 局,抓住关键,纲举目张,做好以下重点工作。一是全力保障药品高水平安全。完善药品安全责任体 系,提升临床试验监管水平,加强高风险品种生产监管,聚焦集采中选等重点品种加大检查和抽检力 度,开展药品经营环节"清源"巩固提升行动,强化网络销售监管,切实守牢药品安全底线。二是积极支 持医药产业发展提质增效。全面深化药品监管改革,落实对重点品种实行"提前介入、一企一策、全程 指导、研审联动"的要求,支持医药研发创新,推动中药守正创新发展,支持医疗器械高水平自立自 强,促进美丽经济发展壮大。三是不断提升药品监管法治化水平。持续健全药品监管法律法规体系,完 善药品标准体系,提高行政执法权威性和公信力,加大面向企业和基层的普法宣传力度,进一步夯实药 品监管的法治基础。四是扎实推进药品监管现代化建设。高质量编制"十五五"药品规划,扎实推进全国 药品监管一体化,加强监管人才队伍和技术支撑能力建设,深化监管信息化建设和药品监管科学研究应 用,深度参与全球药品安全治理,推动中国药品监管国际影响力再上新台阶。 (文章来源:第一财经) ...
额敏县市场监督管理局:药品“清源”行动,双机制筑牢安全防线
Zhong Guo Shi Pin Wang· 2025-12-29 10:57
下一步,额敏县市场监督管理局将持续强化日常监管与专项整治相结合的工作机制,保持监管高压态 势,严厉打击各类药品经营违法违规行为。同时,加大宣传教育力度,积极引导公众参与药品安全社会 监督,努力营造全社会共同关心、支持和参与药品安全治理的良好氛围。(宋世淇 ) 一是构建"排查-整改-验收"机制,闭环保障安全。行动中坚持以问题为导向,以严厉打击销售假劣药、 非法渠道购进"回流" 药品、执业药师挂证及处方药管理等为重点,建立了"排查-整改-验收"闭环管理机 制,确保问题隐患动态清零,持续筑牢药品安全防线。截至目前,全覆盖检查药品经营企业77家,下达 责令改正通知书26份,查办违规违法案件13起。二是构建"线索共享-联合执法-行刑衔接"机制,提升查 办效能。与卫健、医保、公安等部门协作,建立了"线索共享-联合执法-行刑衔接"机制,积极解决跨部 门线索移送、监管协作、联合执法中遇到的难点焦点等问题,确保违法违规问题一查到底,提升案件查 办效率。截止目前,共开展检查行动8次,向卫健、医保、公安等部门互通案件处理情况5次,移交案件 线索5条。 今年以来,额敏县市场监督管理局为进一步规范药品经营行为、强化药品质量监管深入开展 ...
广东省药品监督管理局关于药品经营监督检查评定结果的通告(2025年第109号)
41 广东愉康大药房有限公司 粤BA756000672 符合要求 珠海市 特此通告。 根据广东省药品监督管理局《2025年药品经营使用单位监督检查计划》安排,省药品监管局组织对以下41家药品经营企业进行监督检查,现将综合评定结论 通告如下: | 序号 | 企业名称 | 药品经营许可证号 | 综合评定结论 | 所在地市 | | --- | --- | --- | --- | --- | | 1 | 陆丰市新特药公司 | 粤AA660000846 | 符合要求 | 汕尾市 | | 2 | 广东新发医药有限公司 | 粤BA768000444 | 符合要求 | 潮州市 | | 3 | 广东修芝药业有限公司 | 粤BA769000515 | 符合要求 | 东莞市 | | 4 | 东莞市丰源医药连锁有限公司 | 粤BA769000523 | 符合要求 | 东莞市 | | 5 | 佛山市南海康生世家医药连锁有限公司 | 粤BA757000445 | 符合要求 | 佛山市 | | 6 | 国药控股广州有限公司 | 粤AA020001000 | 符合要求 | 广州市 | | 7 | 国药控股广州有限公司 | 粤BA020000 ...
兵团持续筑牢药品安全防线
Xin Lang Cai Jing· 2025-12-19 18:23
据介绍,"清源行动"同步排查经营行为风险,同步组织区域联动执法检查,同步推进重点任务落实,充 分发挥"三医"协同发展和治理机制作用,依法依规打击药品经营环节违法违规行为。截至目前,兵、师 两级监管部门检查药品经营企业2453家次,对发现的涉嫌违规单位均已要求其按时完成整改。 在"清源行动"中,兵团药监局坚持部署联动执法,直击药品经营过程中的难点痛点,针对药品批发企业 和零售连锁总部重点检查是否存在超范围经营、从非法渠道进货、篡改企业计算机系统数据、未按规定 上传药品追溯码信息或提供的药品追溯码信息无法校验等问题,采取多项监管举措整治行业乱象,有效 净化药品市场环境,进一步筑牢药品安全防线。 本报乌鲁木齐讯(全媒体记者 谌慧) 记者从兵团药品监管局获悉,今年以来,兵团聚焦药品经营领域 突出问题,深入开展药品经营环节"清源行动",强化全域排查、精准监管、严惩重处,取得阶段性成 效。 ...
山东11.5万家药品经营企业、医疗机构入驻追溯平台
Da Zhong Ri Bao· 2025-12-09 01:02
我省药品全品种追溯体系建设成效凸显。目前,全省11.5万家药品经营企业、医疗机构已入驻追溯 平台,入驻单位数量及入驻率均居全国首位。(记者 刘英 通讯员 赵洪涛) 此次"清源行动"精准聚焦药品经营领域五大核心痛点,破解行业乱象。针对非法渠道购销药品问 题,严厉打击假劣药品、医保回流药品流通乱象,减少质量安全风险隐患;整治处方药销售不规范问 题,遏制不凭处方、不审核处方销售处方药等行为;规范互联网药品销售秩序,通过全网域监测排查, 从严处置线上违法违规销售行为;压实企业主体责任,通过普法宣贯、警示教育,推动企业强化自律、 合规经营。 记者近日从省药监局获悉,自药品经营环节"清源行动"开展以来,山东聚焦药品经营领域突出问 题,强化全域排查、精准监管、严惩重处,取得阶段性成效,有效净化药品市场环境,筑牢公众用药安 全防线。 行动中,全省药监系统坚持"全域覆盖、全网排查、全链打击",多项监管举措落地见效。实施药品 追溯"触发式"监管,为3000余名监管人员开通专用App,制定处置流程和明白纸,组织开展培训,推广 模块应用,实现线上线下精准监管;开展全域药品网络违法监测,对药品网络销售企业实施全时段监 测,及时处置涉嫌 ...
甘肃省药品监督管理局公布5起药品领域违法案件典型案例
Core Points - The article emphasizes the ongoing efforts of drug regulatory authorities in Gansu Province to enhance drug safety and combat illegal activities in the pharmaceutical sector [2] - It highlights the enforcement actions taken against several companies for violations of drug management laws [3][4][5][6] Summary by Category Regulatory Actions - Gansu Province's drug regulatory departments are implementing decisions from higher authorities to strengthen drug safety and regulation [2] - A series of typical cases of illegal activities in the pharmaceutical sector have been disclosed to the public [2] Case Summaries 1. **Tianshui Xinguang Pharmaceutical Co., Ltd.**: The company was penalized for selling drugs with false sales records, resulting in a confiscation of illegal gains amounting to 1,159.8 yuan and a fine of 110,000 yuan [3] 2. **Xianheimai**: This entity was found to be producing and selling drugs without the necessary licenses, leading to the confiscation of illegal gains of 11,850 yuan and a fine of 25,875 yuan [3] 3. **Jiuquan City Jiuyi Pharmacy**: The pharmacy submitted false materials to obtain a drug business license, resulting in the revocation of its license and a fine of 20,000 yuan [4] 4. **Zhangye Shanai Hospital**: The hospital was found using expired medical devices, leading to the confiscation of the devices and illegal gains of 49,554 yuan [5] 5. **Minle County Li Wenhui Cosmetics Store**: The store was penalized for selling expired cosmetics, resulting in the confiscation of the products and a fine of 2,000 yuan [6]
额敏县市场监督管理局: 规范药品经营使用,守护群众用药安全
Zhong Guo Shi Pin Wang· 2025-10-23 09:03
Core Viewpoint - The E'min County Market Supervision Administration is committed to maintaining drug market order and ensuring drug safety through regular and detailed inspections of pharmacies and medical institutions [1][2] Group 1: Regulatory Focus - The administration emphasizes three core areas during inspections of retail pharmacies: compliance with qualifications, operational standards, and quality control [1] - Inspections include verifying the validity of drug operation licenses and ensuring that pharmacists are present and following proper prescription protocols [1] - The storage conditions of drugs are also scrutinized, ensuring that cold storage temperatures meet standards and that drugs are stored according to regulations to prevent quality issues [1] Group 2: Medical Institutions Oversight - The administration focuses on traceability of sources, quality control, and compliance in the procurement and use of drugs and medical devices in medical institutions [1] - Key checks include ensuring that medical institutions purchase drugs and devices from legal channels and do not use expired or unqualified products [1] Group 3: Approach to Regulation - The administration adopts a dual approach of service and regulation, combining education with enforcement, addressing minor issues with on-the-spot guidance and taking legal action against violations [2] - Future plans include maintaining a high-pressure regulatory stance through regular inspections and follow-up checks to reinforce regulatory effectiveness [2]
柳林召开药品经营企业警示教育会
Sou Hu Cai Jing· 2025-09-25 01:31
Core Points - The meeting organized by the Liu Lin County Market Supervision Administration focused on advancing the "Clearing Source" action in the pharmaceutical sector and educating pharmaceutical enterprises on warnings [1][3] - Liu Lin County has made progress in drug safety this year, but there are still shortcomings that need to be addressed, such as the inadequate implementation of corporate responsibilities and a weak awareness of the "first responsible person" [1][3] - The director emphasized the importance of drug safety for public health and social stability, urging for stronger measures and practical approaches to ensure the safety and effectiveness of medications for the public [3] Summary by Sections Meeting Overview - The meeting was chaired by Gao Xuemei, a level-three chief staff member, and included specific work arrangements [1] - Niu Fuying, a section chief, reported on warning cases during the meeting [1] Current Status and Challenges - Liu Lin County has achieved certain results in drug safety, but there are still issues such as insufficient corporate responsibility and a need for enhanced grassroots regulatory capabilities [1][3] Future Actions - The director called for a resolute commitment to drug safety, emphasizing the need for effective measures and a practical approach to strengthen drug safety efforts in Liu Lin County [3]
海南省药品监督管理局关于依法注销海南天诺药业有限公司等3家企业 《药品经营许可证》的公告(2025年第5号)
Core Points - The Hainan Provincial Drug Administration has legally revoked the drug business licenses of three companies: Hainan Tiannuo Pharmaceutical Co., Ltd., Hainan Yangpu Junhe Pharmaceutical Co., Ltd., and China National Pharmaceutical Group Professional Pharmacy Chain (Hainan) Co., Ltd. [2][4] - The revocation requires these companies to immediately cease drug business activities and invites public supervision [2][4]. Company Summaries - **Hainan Tiannuo Pharmaceutical Co., Ltd.** - Location: 2nd Floor, No. 22B1 and 22B2, Shimao Yayu, Shimao East Road, Haikou City, Hainan Province - Warehouse Address: No. 10, Jianzheng Road, National Pharmaceutical Holdings Hainan Co., Ltd. [3] - Business Scope: Traditional Chinese medicine, chemical drugs (including raw materials), biological products (excluding refrigerated and frozen drugs) [3]. - License Number: AA898000025 [3]. - **Hainan Yangpu Junhe Pharmaceutical Co., Ltd.** - Location: H206, H Building, Hainan Yangpu Economic Development Zone [3]. - Warehouse Address: No. 10, Jianzheng Road, National Pharmaceutical Holdings Hainan Co., Ltd. [3]. - Business Scope: Chinese herbal pieces, traditional Chinese medicine, chemical drugs (including raw materials), biological products, protein anabolic agents, and peptide hormones (including refrigerated and frozen drugs) [3]. - License Number: AA898000235 [3]. - **China National Pharmaceutical Group Professional Pharmacy Chain (Hainan) Co., Ltd.** - Location: No. 10, Jianzheng Road, Longhua District, Haikou City, Hainan Province [3]. - Warehouse Address: No. 10, Jianzheng Road, National Pharmaceutical Holdings Hainan Co., Ltd. [3]. - Business Scope: Chinese herbal pieces, traditional Chinese medicine, chemical drugs, biological products (excluding cell therapy biological products), blood products, protein anabolic agents, and peptide hormones (limited to insulin, including refrigerated and frozen drugs) [3]. - License Number: BA898000053 [3].
新疆乌苏市市场监管局把好国庆节前“安全关”
Zhong Guo Shi Pin Wang· 2025-09-23 03:53
Core Viewpoint - The Xinjiang Uygur Autonomous Region's Urumqi City Market Supervision Administration is actively conducting safety inspections in preparation for the upcoming National Day holiday to ensure public safety and prevent accidents [1][3]. Group 1: Food Safety - Focus on inspecting holiday-related food items such as grains, oils, vegetables, and fruits, with special checks on the sourcing, product certification, shelf life, and inventory records of food sold in markets and supermarkets [3]. - Inspections will also target hot pot restaurants and large-scale dining establishments, with a commitment to follow up on any identified issues to ensure compliance with food safety responsibilities [3]. Group 2: Drug Safety - Random checks will be conducted on standalone pharmacies, medical institutions, chain stores, and cosmetic businesses to ensure compliance with safety regulations, with a focus on rectifying any discovered issues [3]. Group 3: Special Equipment Safety - Comprehensive safety inspections will be carried out on special equipment such as pressure vessels, boilers, elevators, and forklifts, ensuring that safety management protocols are effectively implemented [3]. - Immediate corrective actions will be mandated for any identified problems, and safety regulations will be communicated to equipment operators to enhance overall safety awareness [3]. Group 4: Future Actions - The administration plans to intensify safety supervision during the holiday period, streamline complaint channels, and strictly enforce laws to protect the rights of consumers and operators, ensuring a joyful holiday for the public [4].