转自：北京日报客户端 1月6日至7日，全国药品监督管理工作会议在北京召开。会议以习近平新时代中国特色社会主义思想为 指导，全面贯彻落实党的二十大和二十届历次全会精神，认真落实中央经济工作会议部署，总结2025年 和"十四五"药品监管工作，分析当前面临形势，部署2026年重点任务。市场监管总局党组书记、局长罗 文出席会议并讲话。市场监管总局党组成员，国家药监局党组书记、局长李利作工作报告。国家药监局 党组成员、副局长徐景和、黄果、雷平、杨胜，中央纪委国家监委驻市场监管总局纪检监察组负责同志 出席会议。 会议指出，2025年，全国药监系统认真落实习近平总书记"四个最严"要求，全面加强党的领导和党的建 设，全过程深化药品监管改革，全方位筑牢药品安全底线，全链条支持医药产业高质量发展，新批准创 新药和医疗器械数量创历史新高，全国药品安全形势保持总体稳定，人民群众对药品监管的获得感进一 步充实，为"十四五"时期药品监管改革发展画上圆满句号。五年来，药品监管部门服务国家区域发展战 略取得新进展，药品安全保障水平得到新提升，医药产业创新发展实现新跨越，药品监管国际话语权达 到新高度，监管现代化水平迈上新台阶，《"十四五"国 ...

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） ...

新华社北京12月31日电（记者 戴小河）12月31日召开的国务院常务会议，审议通过《中华人民共 和国药品管理法实施条例（修订草案）》。 中央党校（国家行政学院）经济学教研部教授蔡之兵表示，审议通过药品管理法实施条例修订草案 对百姓用药安全及产业发展具有重要意义。首先，条例强调全链条全流程监管，从研发到使用严管药品 质量，直接保障百姓用药安全。其次，激活产业发展动能，完善研审制度和突破性治疗药物加快审评审 批，可以加快创新药上市，既鼓励药企敢投敢研，也能让创新药更快落地，促进医药产业从"仿 制"向"创新"升级，做强国产医药产业。再次，夯实法治根基，紧随形势修订法规，把药品监管的"严要 求"固化成"硬制度"，让监管有法可依、执法更硬。 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。 新华社北京12月31日电（记者 戴小河）12月31日召开的国务院常务会议，审议通过《中华人民共 和国药品管理法实施条例(修订草案)》。 中央党校（国家行政学院）经济学教研部教授蔡之兵表示，审议通过药品管理法实施条例修订草案 对百姓用药安全及产业发展具有重要意义。首先，条例强调全链条全流程监管，从研发到使用严管药品 质量，直接保障百姓用药安全。其次，激活产业发展动能，完善研审制度和突破性治疗药物加快审评审 批，可以加快创新药上市，既鼓励药企敢投敢研，也能让创新药更快落地，促进医药产业从"仿 制"向"创新"升级，做强国产医药产业。再次，夯实法治根基，紧随形势修订法规，把药品监管的"严要 求"固化成"硬制度"，让监管有法可依、执法更硬。 ...

南都讯 记者刘嫚 发自北京 重庆市石柱县多家零售药店违规销售处方药，租借执业药师资格证件，形成 执业药师"挂名"在岗现象，检察机关向市场监管局制发检察建议，督促纠正违规销售处方药现象。12月 22日，最高人民法院、最高人民检察院召开发布会，联合发布"行政公益诉讼典型案例（第三批）"，上 述案例入选。 典型案例显示，石柱土家族自治县人民检察院（以下简称石柱县检察院）经调查发现石柱县多家零售药 店未严格落实处方药销售管理相关法律规定，在未审核真实有效处方的情况下，直接向消费者销售处方 药；随意补录电子处方，在销售处方药后违规补登虚假电子处方以应付监督检查；租借执业药师资格证 件，形成执业药师"挂名"在岗现象；安排不具备执业药师资质的人员冒名签署处方，规避处方药审核相 关要求。上述违法行为，不仅容易导致消费者错误用药，引发药源性疾病，严重威胁人民群众用药安 全，而且扰乱药品经营监管秩序，削弱了处方药管理制度对公共健康的保障作用，损害社会公共利益。 2021年5月28日，石柱县检察院对石柱县市场监督管理局（以下简称石柱县市监局）立案，并于2021年6 月24日向该局制发检察建议，建议其立即进行整改并建立长效监管机制。 ...

人民财讯12月13日电，12月12日，国家药监局召开党组扩大会议，会议强调，做好明年药品监管工作， 要坚持稳中求进、提质增效，着力营造公开、透明、可预期的药品监管环境，稳定药品安全形势大局， 促进医药研发创新提质增效，努力为全国经济发展大局贡献更多药监力量。一要进一步提升药品安全保 障水平，持续完善药品安全责任体系，健全常态化的药品安全风险会商机制，把风险化解在萌芽状态。 二要进一步支持医药产业高质量发展，提高审评审批质效，对重点品种实行"提前介入、一企一策、全 程指导、研审联动"，支持创新药和医疗器械发展。三要进一步促进"三医"协同发展和治理，严格按照 国际公认标准开展仿制药质量和疗效一致性评价，强化集采中选产品质量监管，支持中药传承创新发 展。四要进一步加强监管体系和能力建设，完善法规标准体系，大力发展智慧监管和监管科学，提升药 品监管现代化水平。 会议要求，要切实做好岁末年初药品监管工作，针对冬季呼吸道疾病多发态势，加强有关重点药品的监 管力度，保障节假日期间药品安全形势稳定。要有力有序抓好各项工作落实，科学谋划明年重点工作， 确保"十四五"各项工作圆满收官，实现"十五五"良好开局。 ...

齐鲁晚报·齐鲁壹点 张唯 "安全"是药品监管的首要任务。12月11日下午，在山东省政府新闻办举行的"'十四五'时期山东扎实推进 市场监管现代化建设情况"新闻发布会上，围绕"十四五"期间山东在药品监管方面采取了哪些管用新办 法守牢用药安全底线等问题，山东省药品监督管理局党组书记、局长李涛作出回应。 李涛介绍，"十四五"以来，山东省药监局深入贯彻落实"四个最严"要求，持续深化"安全提升""鲁药振 兴""铁军锻造"三大工程，铁腕守护安全底线，用心筑牢民生防线。 在责任落实方面，山东持续构建"三位一体"的责任落实体系。不断完善地方属地、部门管理、企业主 体"三位一体"责任落实体系，在全国率先以党内文件出台药品安全党政同责规定，压实地方属地和部门 管理责任。出台《药品经营监督管理办法》《药品使用质量管理规范》等，制定加强委托生产监管"一 细则、两清单、三指南"（药品持有人落实主体责任实施细则，化妆品注册人备案人主体责任清单、负 面清单，对受托生产企业遴选指南、对受托生产企业审核指南、医疗器械注册人委托生产现场检查指 南），有效督促企业主体责任落实。指导企业坚持"质量为本，以质取胜"，新华制药（000756）通过德 国默 ...

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation in promoting the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1]. Group 1: Achievements During the 14th Five-Year Plan - The NMPA has implemented comprehensive reforms in drug regulation, ensuring overall stability in drug safety and advancing the construction of a strong pharmaceutical nation [2]. - Continuous strengthening of supervision has led to a significant increase in the overall pass rate of drug safety inspections from 97.8% during the 13th Five-Year Plan to 99.4% [2]. - A total of 220 innovative drugs and 282 innovative medical devices have been approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3]. Group 2: Future Measures for Drug Safety Regulation - The NMPA plans to enhance the drug safety responsibility system and transition from a "passive defense" to a "proactive prevention" approach [5]. - A focus on dynamic safety regulation across the entire supply chain will be implemented, addressing new challenges posed by product and technological innovations [6]. - Strict enforcement against illegal activities will be prioritized, with improved mechanisms for cross-regional and cross-level case handling [6]. Group 3: Support for Innovative Drug and Medical Device Development - The NMPA will support enterprises in enhancing their research and development capabilities for innovative drugs and medical devices, emphasizing the importance of effective market and proactive government roles [7]. - Policies will be optimized to accelerate the approval process for innovative products, particularly those that are globally novel or critical for domestic substitution [8]. - The NMPA aims to improve the regulatory framework for traditional Chinese medicine, ensuring quality management and modernization of production processes [8]. Group 4: Enhancing Public Benefit from Regulatory Reforms - The NMPA will prioritize enhancing public access to innovative treatments and ensuring that regulatory reforms benefit the general population [9]. - Efforts will be made to streamline the approval process for urgently needed drugs, including those for rare diseases and pediatric use [9]. - Collaboration with health and insurance departments will be strengthened to ensure comprehensive drug safety and accessibility [10].

Core Viewpoint - The article emphasizes the importance of strict regulation in promoting the development of innovative drugs and medical devices, highlighting the balance between ensuring drug safety and fostering industry innovation [1] Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, China's drug regulatory system has adhered to the "four strictest" requirements, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2] - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2] Group 2: Promoting Industry Innovation - A total of 220 innovative drugs and 282 innovative medical devices were approved since the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines, indicates a growing vitality in pharmaceutical innovation [3] Group 3: Future Measures for Drug Safety - The regulatory focus will shift from "passive defense" to "active prevention," enhancing the drug safety responsibility system and improving risk management capabilities [4] - A comprehensive dynamic safety supervision system will be established, covering the entire lifecycle of drugs, from research and development to production and use [5] Group 4: Supporting Innovation in Pharmaceuticals - The regulatory body will support enterprises in enhancing their innovative drug and medical device research and development, emphasizing policy guidance and resource allocation for original products [6] - Efforts will be made to accelerate the market entry of innovative drugs and medical devices by optimizing registration processes and reducing costs [7] Group 5: Enhancing Public Welfare - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that regulatory reforms benefit all citizens and meet their health needs [8] - Measures will be taken to expedite the approval of urgently needed drugs, including those for rare diseases and children, while maintaining high standards [9] Group 6: Interdepartmental Collaboration - Strengthening coordination with health and insurance departments will be crucial for improving clinical trial oversight and drug traceability systems [10] - Public awareness campaigns will be conducted to enhance understanding of drug regulations and promote a supportive environment for innovative drug and device development [11]

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation to promote the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1][2]. Regulatory Achievements During the 14th Five-Year Plan - The NMPA has implemented comprehensive reforms in drug regulation, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2]. - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2]. Industry Innovation and Development - A total of 220 innovative drugs and 282 innovative medical devices were approved during the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3]. - The NMPA has also approved 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines [3]. Strengthening Regulatory Capacity - The NMPA has revised key regulatory laws and established a more comprehensive legal framework for drug regulation, enhancing the consistency of Chinese standards with international standards [4]. - The establishment of new inspection centers and regional review centers has improved the regulatory capacity of the NMPA [4]. Transition to Proactive Drug Safety Management - The NMPA aims to shift drug safety management from a "passive defense" approach to a "proactive prevention" model, enhancing risk identification and responsibility accountability [5]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [6]. Support for Innovative Drug and Medical Device Development - The NMPA plans to enhance support for the research and development of innovative drugs and medical devices, focusing on policy guidance and resource allocation for original products [7]. - Efforts will be made to streamline the approval process for innovative products and improve the protection of intellectual property rights related to drug research [8]. Ensuring Public Benefit from Regulatory Reforms - The NMPA is committed to ensuring that regulatory reforms benefit the public, focusing on enhancing people's sense of gain, happiness, and safety [9]. - The agency will expedite the approval of urgently needed drugs and maintain high standards for generic drug quality to ensure affordable access to effective medications [9]. Collaborative Governance in Healthcare - Strengthening collaboration with health and insurance departments is essential for improving clinical trial oversight and drug traceability [10]. - The NMPA will enhance public awareness of drug safety and regulatory policies through education and outreach initiatives [10].