为进一步规范药品经营环节监管行为，有效应对新业态、新模式带来的监管挑战，近日，平川区市场监督管理局组织开展以"严守经营底线，筑牢用药安 全"为主题的业务知识培训，全局99名干部职工参训。 作 者：白爱琴 核 稿：何 丹 审 核：卢昌贵 来 源：平川区市场监督管理局 白银市市场监督管理局尊重作者权益，共同维护网络知识产权。 此次培训紧扣《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》《药品网络销售监督管理办法》等法律法规要求，聚焦药品经营全链 条监管重点，从药品购进宣传、验收储存、人员管理三大模块展开系统讲解。培训内容紧贴监管实际，围绕药品经营环节人员资质审核、培训考核制度、 处方药调配规范、人员职责划分等关键内容深入解读，清晰界定企业主体责任与监管人员监督责任的边界；详细阐释供货单位资质审核标准、购销凭证留 存要求及票账货一致性检查要点；针对电商平台、直播带货等药品经营新业态，重点明确虚假宣传、夸大疗效等违规行为的甄别方法与执法尺度；同时强 调近效期药品预警机制建立与落实的重要性，全方位覆盖监管工作的重难点。 此次培训通过细化监管要点、剖析典型案例，进一步规范梳理了药品经营监管流程，明确了执法工 ...

本报内蒙古讯 （记者常锐博） 近日，《内蒙古自治区药品监督管理行政许可裁量权基准》《内蒙古自 治区药品监督管理行政检查裁量权基准》《内蒙古自治区药品监督管理行政强制裁量权基准》《内蒙古 自治区药品监督管理行政奖励裁量权基准》4项行政裁量权基准印发，旨在统一行政裁量标准，进一步 规范"两品一械"监管行为。上述4项基准均于今年1月1日起实施。 （来源：中国医药报） 转自：中国医药报 《内蒙古自治区药品监督管理行政强制裁量权基准》对"两品一械"监管中涉及的12项行政强制措施作出 具体裁量规定，明确了每项行政强制措施的实施、延期与解除3种情形的实施依据、适用条件和适用程 序等。 《内蒙古自治区药品监督管理行政奖励裁量权基准》明确了行政奖励的设定依据、实施层级、奖励条件 等10项内容，为规范实施相关行政奖励提供了具体依据与操作标准。 其中，《内蒙古自治区药品监督管理行政许可裁量权基准》涵盖药品生产许可、医疗机构制剂配制许可 及化妆品生产许可等26类行政许可主要事项、66个子事项。针对每一子事项，该基准明确了设定依据、 许可条件、证书名称、申请材料、审批时限和办理流程，形成了规范、系统的行政许可操作标准。 《内蒙古自治区 ...

（文章来源：人民日报） 会议指出，供水事业是民生事业，关系千家万户。要坚持城乡统筹，促进城市供水和农村供水共同发 展，着力构建从水源到水龙头的全链条规范体系。要因地制宜实现多水源互补，加力支持供水管网更新 改造，做好调压调蓄等终端设施日常维护，确保水质安全。要督促供水单位严格落实法规制度，开展规 范化、专业化运营，加强供水安全风险管控，增强应急管理和处置能力，持续提升供水经营服务水平。 会议指出，根据形势变化及时修订药品管理监督法律法规，对于保障人民群众用药安全、促进医药产业 健康有序发展具有重要意义。要完善药品研制和注册制度，加快突破性治疗药物审评审批，不断激发产 业创新发展活力。要保持药品监管高压态势，加强全链条全流程质量监管，严厉打击药品领域违法违规 行为。 会议还研究了其他事项。 新华社北京12月31日电国务院总理李强12月31日主持召开国务院常务会议，听取国家水网建设情况汇 报，部署复制推广跨境贸易便利化专项行动政策措施，审议通过《供水条例（草案）》和《中华人民共 和国药品管理法实施条例（修订草案）》。 会议指出，近年来各地、各有关部门认真落实《国家水网建设规划纲要》，国家水网主骨架和大动脉逐 步完 ...

《意见》提出，要加强药品审评审批、检查稽查、检验检测、标准研制、监测评价等专业领域人才队伍 建设，探索建立审评员分级分类管理制度，建立覆盖研发、注册、生产、经营等全过程的职业化专业化 检查员队伍，培养创新领域检验检测人才，加强药物警戒机构人员力量配备，推动药品全生命周期的科 学监管。《意见》同时提出，要加强市县级药品监管人才队伍建设，明确了市县级从事药品监管工作人 员中具有医药相关专业背景人员的比例要求；要建设中国特色中药监管人才队伍，分层次、分专业、规 模化构建中药监管人才队伍；要构筑药品监管领军人才队伍，以国家级、省级技术支撑单位为主要载 体，分领域培养、选拔、引进一批领军人才；要培育优秀青年人才队伍，鼓励支持优秀青年人才到监管 工作一线锻炼，在重点工作、重大项目、重大案件中"挑大梁""当主角"，工作成效作为职称评审、职务 职级晋升等重要参考。 《意见》明确，要完善人才培养机制，分领域培养一批专业技术人才骨干、加快推进药品监管相关学科 专业体系建设、加强对全系统专业人才培训和实训。改革人才评价晋升机制，加快推进以创新价值、能 力、贡献为导向的人才评价体系建设，对工作中取得重大突破、做出突出贡献的专业人才和 ...

Group 1 - The Qinghai Provincial Drug Administration has strengthened collaboration with health, medical insurance, and other departments to promote the coordinated development and governance of the "three medicines" [1] - The province has completed the integration of various systems, including medical institution basic information, vaccine planning, adverse reaction monitoring, and drug smart supervision platforms [1] - A total of 150 types of Tibetan and Mongolian medicine pieces and 531 types of Tibetan and Mongolian medical institution preparations have been included in the medical insurance payment scope [1] Group 2 - Continuous reinforcement of drug quality supervision has been emphasized, focusing on key areas, links, and varieties through various special rectification actions [2] - The establishment of a problem ledger and implementation of a closure management system to strengthen corporate responsibility [2] - A comprehensive annual inspection plan for drugs, medical devices, and cosmetics has been developed to enhance the targeting and coverage of inspections [2]

长期以来，市市场监督管理局高度重视家庭过期药品处理难题，出台《镇江市家庭过期药品回收管 理工作指南》，推动家庭过期药品定点回收、集中销毁工作走向"常态化、制度化、规范化"。截至目 前，全市已设立890家定点回收点，全面覆盖各板块及镇（街道），实现"群众家门口就能回收"的便捷 服务，极大降低了市民参与过期药品回收的门槛。 熊青海介绍，市场监管部门将持续加大宣传力度，积极倡导"按需购药、安全用药、规范弃药"理 念，不断提升群众的药品安全意识与环保意识；同时，将动员更多药品零售企业加入回收体系，进一步 完善回收网络布局，打造更方便快捷、规范有序的家庭过期药品回收处置格局。（孙宁 记者 朱婕 见习 记者 丁星） 12月25日，市市场监督管理局联合各市、区市场监管部门，开展2025年度家庭过期药品集中销毁活 动，守护公众用药安全与生态环境安全。 活动现场，回收的2.2万余盒家庭过期药品整齐收纳于专用纸箱中，等待由生态环境部门授权的危 险废物专业处理机构进行规范化无害化处置。整个销毁过程严格遵循安全、规范、环保的原则，从源头 杜绝过期药品重新流入市场、危害公众健康的风险。 "我们已建立起定点回收、统一转运、专业销毁的全链 ...

Core Viewpoint - The Sichuan Provincial Drug Administration is actively enhancing drug regulation and quality control through a multi-faceted approach, focusing on safety, efficiency, and public welfare during the "14th Five-Year Plan" period [3][4][9]. Group 1: Regulatory Framework - The Sichuan Provincial Drug Administration is building a scientific and efficient drug regulatory system, emphasizing government leadership, departmental collaboration, and social governance [4]. - A clear responsibility system has been established to enhance regulatory effectiveness, with a three-tier and five-region regulatory framework [4]. - The administration has strengthened coordination with 26 departments to advance drug safety collectively [4]. Group 2: Digital Transformation - Digital transformation initiatives have made drug regulation smarter, with online processing for all regulatory procedures and an electronic traceability system for drugs [5]. - The implementation of a unique identification system for medical devices has resulted in over 22,600 data uploads, ranking eighth nationally [5]. - The establishment of seven key laboratories has positioned Sichuan as a leader in the western region for drug monitoring and safety [5]. Group 3: Talent Development - The administration has developed a professional title evaluation system for pharmaceutical engineering and non-clinical pharmacy, assessing 199 individuals to support high-quality industry development [6]. - Continuous training programs have been conducted, with over 10,000 participants, to enhance the professional skills of regulatory personnel [6]. - Competitions and events have been organized to showcase the capabilities of the drug inspection industry in Sichuan [6]. Group 4: Comprehensive Safety Control - A systematic approach has been adopted to ensure safety throughout the entire drug lifecycle, from research and development to usage [7]. - The administration has conducted over 60,000 inspections in the past five years, achieving a compliance rate of 99.6% for drugs and 98.2% for medical devices [8]. - Collaborative efforts with Chongqing have been initiated to create an integrated drug regulatory model, enhancing regional cooperation [8]. Group 5: Industry Support and Innovation - The Sichuan Provincial Drug Administration is addressing barriers to innovation in the pharmaceutical industry by launching a user community platform for medical devices [9]. - A proactive service model has been implemented to support enterprises, reducing the average review time for innovative products by 86% [10]. - The administration has streamlined approval processes, significantly improving efficiency in drug and medical device registrations [11].

人民网北京12月10日电 （记者孙红丽）据国家药监局网站消息，12月9日，国家药监局党组书记、 局长李利主持召开党组会议，研究部署药品监管人才工作，审议《关于加强新时代药品监管人才工作的 实施意见》。 会议指出，人才是全面加强药品监管能力建设，实现药品监管现代化的基础性、战略性支撑。加强 药品监管人才工作，是贯彻落实党的二十大和二十届历次全会精神以及中央人才工作会议精神的重要举 措，是推动全系统人才工作高质量发展的必然要求，对于保障药品安全、促进医药产业发展具有重要意 义。 会议强调，要以深化人才发展体制机制改革为牵引，围绕药品审评审批、检查稽查、检验检测、标 准研制、监测评价等核心专业队伍建设，持续完善人才培养机制，改革人才评价机制，健全人才激励机 制，创新人才流动机制，着力打造一支政治过硬、业务精湛、规模适当、结构合理的高素质药品监管人 才队伍，为推动药品监管现代化提供有力支撑。 会议要求，要加强对全系统人才工作的统筹和指导，落实各级药品监管部门党管人才政治责任，及 时解决人才工作中的堵点难点问题，确保人才工作各项任务落地落实，着力推动药品监管人才工作再上 新台阶。 ...

Core Points - The article emphasizes the importance of promoting constitutional awareness and legal education within the pharmaceutical regulatory system in Shanghai, aligning with the broader goals of national modernization and high-quality economic development [1][4][8] Group 1: Activity Goals - The activities aim to strengthen constitutional education and promote the rule of law, ensuring the effective implementation of the Constitution to support the development of the biopharmaceutical industry [1][4] Group 2: Activity Schedule - The activities will take place from December 1 to December 7, 2025, with flexibility for units to extend the duration based on their circumstances [2] Group 3: Activity Theme - The central theme is to learn, promote, and implement Xi Jinping's thoughts on the rule of law, ensuring the Constitution becomes deeply ingrained in society [3] Group 4: Promotion Focus - Key areas of focus include: - Promoting the spirit of the 20th Central Committee's Fourth Plenary Session [4] - Emphasizing Xi Jinping's thoughts on the rule of law [4] - Highlighting the achievements of constitutional education over the past 40 years [4] - Advocating for a law-based business environment to support modernization and high-quality development [4] - Promoting specific pharmaceutical regulations and laws [4] Group 5: Key Content - The activities will include: - Learning and promoting the spirit of the 20th Central Committee's Fourth Plenary Session and Xi Jinping's thoughts on the rule of law [5] - Organizing educational activities for staff on the Constitution and relevant laws [5][6] - Ensuring that leaders and enforcement personnel are well-versed in key laws related to drug regulation [6][7] - Encouraging the sharing of best practices in legal education among regulatory units [7] Group 6: Work Requirements - Emphasis on political awareness and leadership in organizing constitutional promotion activities [8] - Innovation in legal education methods to enhance public understanding of drug safety [8] - Utilizing various media platforms to increase the effectiveness of constitutional promotion [8]

Core Viewpoint - The "14th Five-Year Plan" period marks a critical phase for the pharmaceutical regulatory sector in Shaanxi Province, emphasizing the importance of political leadership, regulatory rigor, and innovation to ensure drug safety and promote the development of the pharmaceutical industry [1] Group 1: Leadership and Governance - The Shaanxi Provincial Drug Administration has integrated the leadership of the Communist Party into all aspects of drug regulation, aiming to build a trustworthy regulatory team [2] - The agency has implemented a standardized construction of party branches and created 35 party brand initiatives to enhance regulatory effectiveness [3] Group 2: Regulatory Framework and Risk Management - The agency has established a comprehensive drug safety protection system, focusing on risk prevention and control, and has developed a risk assessment mechanism to proactively manage potential issues [6][7] - A total of 4,839 inspections of drug production and 442,303 inspections of drug distribution and use have been conducted, leading to the identification and rectification of numerous violations [8] Group 3: Technological Innovation and Digital Transformation - The Shaanxi Provincial Drug Administration is advancing a smart regulatory system, including the establishment of a drug safety regulatory platform and a drug regulatory big data center, which has processed over 21.7 million applications [10][11] - The drug safety risk management system has identified 23,614 safety risk signals, providing a robust technical foundation for high-quality regulatory oversight [12] Group 4: Industry Support and Development - The agency has optimized the review and approval processes for innovative drugs, significantly reducing approval times and supporting the development of 77 innovative drug specifications [14][15] - Policies have been implemented to encourage the quality and efficacy consistency of generic drugs, with a total of 52.7 million yuan in rewards distributed to relevant enterprises [16] Group 5: Cultural and Educational Initiatives - The agency has focused on enhancing the cultural atmosphere of integrity within the pharmaceutical sector, addressing 288 issues and implementing 397 corrective measures over five years [5] - Educational programs and training sessions have been conducted to improve the capabilities of regulatory personnel, including 230 participants in emergency management training [7]