李强签署国务院令 公布修订后的《中华人民共和国药品管理法实施条例》 国务院总理李强日前签署国务院令，公布修订后的《中华人民共和国药品管理法实施条例》（以下简称《条 例》），自2026年5月15日起施行。《条例》共9章89条，修订后的主要内容如下。 一是完善药品研制和注册制度。支持以临床价值为导向的药品研制和创新，鼓励研究和创制新药，支持新药临 床推广和使用。明确药物非临床安全性评价研究机构资格认定程序，细化药物临床试验管理要求。设立药品上 市注册加快程序，明确药品再注册程序，规定处方药、非处方药转换机制。对符合条件的儿童用药品、罕见病 治疗用药品给予市场独占期，对含有新型化学成份的药品等进行数据保护。细化药品上市许可持有人的责任。 国家药监局政策法规司司长张琪介绍，《药品管理法实施条例》是《药品管理法》的重要配套行政法规。现行 条例是2002年公布施行，曾有3次对个别条款进行修改，这次修订是条例施行23年来的首次全面修订。 据介绍，与23年前相比，我国药品研制、生产、流通、使用各环节都发生巨大变化，法律法规制度也需要顺应 变化，修订完善。 据了解，现行条例于2002年公布施行，包括药品生产企业管理、药品经营企 ...

国务院总理李强日前签署国务院令，公布修订后的《中华人民共和国药品管理法实施条例》（以下简称 《条例》），自2026年5月15日起施行。《条例》共9章89条，修订后的主要内容如下。 一是完善药品研制和注册制度。支持以临床价值为导向的药品研制和创新，鼓励研究和创制新药，支持 新药临床推广和使用。明确药物非临床安全性评价研究机构资格认定程序，细化药物临床试验管理要 求。设立药品上市注册加快程序，明确药品再注册程序，规定处方药、非处方药转换机制。对符合条件 的儿童用药品、罕见病治疗用药品给予市场独占期，对含有新型化学成份的药品等进行数据保护。细化 药品上市许可持有人的责任。 二是加强药品生产管理。严格药品委托生产管理，压实委托生产时药品上市许可持有人的责任，明确可 以委托分段生产药品的情形。明确中药饮片、中药配方颗粒生产、销售的管理要求。 三是规范药品经营和使用。完善药品网络销售管理制度，压实药品网络交易第三方平台提供者责任。加 强医疗机构药事管理，保障使用环节药品质量。明确医疗机构配制制剂审批流程，规定医疗机构制剂调 剂使用条件和程序，支持配制儿童用医疗机构制剂，满足儿童患者用药需求。 四是严格药品安全监管。明确药 ...

Core Viewpoint - The provincial drug regulatory work meeting highlighted the achievements in drug regulation during 2025 and outlined key tasks for 2026, emphasizing the importance of advancing drug safety and promoting high-quality development in the pharmaceutical industry as part of China's modernization efforts [1][2]. Summary by Sections Achievements in 2025 - The provincial drug regulatory work achieved significant results, ensuring overall drug safety stability and promoting high-quality innovation in the pharmaceutical industry, with the province receiving an A rating in national drug safety assessments [2]. - Strong policy support was provided, including the approval of a comprehensive plan for the open innovation development of the biopharmaceutical industry chain by the State Council and the introduction of 83 reform measures by the provincial government [2]. - Continuous deepening of reforms was noted, with the province leading in the number of newly approved drugs and innovative medical devices, and the establishment of a full-process service mechanism [2]. - Regulatory effectiveness improved, with a drug inspection pass rate maintained at over 99.5% and the establishment of a mechanism for corporate responsibility [2]. - Workforce development was emphasized, with a focus on enhancing the quality of drug regulation personnel and fulfilling central directives [2]. Key Tasks for 2026 - The drug regulatory departments are tasked with implementing the spirit of the 20th National Congress and the 14th Provincial Congress, focusing on high-quality development and efficient governance [3]. - There is a call to strengthen integrated services to optimize the innovation environment for the pharmaceutical industry, enhancing support for drug and medical device development [3]. - Full-chain governance will be reinforced to ensure safety throughout the drug lifecycle, extending governance to more areas including cosmetics [3]. - Modernization of drug regulation will be prioritized, with innovations in regulatory methods and tools to enhance predictability and effectiveness [3]. - Strengthening party leadership and building a high-quality cadre team is essential for guiding the development of drug regulation [3]. Future Focus Areas - The focus will be on deepening reforms, enhancing drug safety, and promoting the pharmaceutical industry's innovation and development [5][6]. - Key areas include advancing comprehensive party governance, deepening drug regulatory reforms, and improving the drug safety regulatory system [5][6]. - The establishment of a risk warning and prevention system is crucial to address potential risks at an early stage [6]. - Continuous enhancement of professional capabilities in drug regulation and the modernization of governance practices will be pursued [6].

Core Viewpoint - The article reports on the seizure of 2,682 pieces of "three-no" (unregistered, untested, and unapproved) weight loss pills and capsules by the Yantai Customs, highlighting the risks associated with unregulated substances and the enforcement of drug import regulations in China [1]. Group 1: Incident Details - Yantai Customs discovered suspicious items in the luggage of a traveler using the "no declaration channel" upon arrival [1]. - The traveler claimed the items were for someone else and intended for weight loss purposes [1]. - The seized products tested positive for methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA), both of which are classified as controlled substances with addictive properties [1]. Group 2: Regulatory Context - The import and export of narcotic and psychotropic drugs in China require permits issued by the National Medical Products Administration [1]. - The seized weight loss products were temporarily detained by customs in accordance with the relevant laws and regulations [1].

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） ...

Core Viewpoint - The State Council's meeting on December 31 approved the revised draft of the Drug Administration Law Implementation Regulations, emphasizing the importance of timely updates to drug management laws for ensuring public safety and promoting the healthy development of the pharmaceutical industry [1] Group 1: Drug Safety and Regulation - The revised regulations stress comprehensive supervision throughout the entire drug lifecycle, from research and development to usage, directly safeguarding public medication safety [1] - The meeting highlighted the need for stringent quality supervision across the entire drug supply chain and a strong crackdown on illegal activities in the pharmaceutical sector [1] Group 2: Industry Development - The regulations aim to enhance the drug research and registration system, accelerating the review and approval of breakthrough therapies, which can invigorate innovation within the industry [1] - By improving the review system and expediting the approval of innovative drugs, the regulations encourage pharmaceutical companies to invest in research and development, facilitating a shift from generic to innovative drug production [1] Group 3: Legal Framework - The revisions are intended to solidify the legal foundation for drug regulation, ensuring that stringent regulatory requirements are codified into law, thus providing a clear legal basis for enforcement [1]

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。 ...

Core Viewpoint - The article highlights the illegal sale of prescription drugs by several retail pharmacies in Shizhu County, which involved renting pharmacist qualifications and resulted in a significant public health risk [1][2][3] Group 1: Illegal Activities - Multiple retail pharmacies in Shizhu County were found to be selling prescription drugs without verifying valid prescriptions, leading to potential medication errors and health risks for consumers [1] - Pharmacies engaged in practices such as retroactively entering false electronic prescriptions to evade regulatory scrutiny and allowed unqualified personnel to sign prescriptions [1] - The illegal activities not only jeopardized public health but also disrupted the regulatory order of drug sales, undermining the prescription drug management system [1] Group 2: Regulatory Response - The Shizhu County Procuratorate initiated an investigation and issued recommendations for immediate corrective actions to the local market supervision bureau, which showed some improvement in compliance [2] - Despite initial improvements, ongoing reports indicated that nine pharmacies continued to engage in illegal sales, prompting the Procuratorate to file an administrative public interest lawsuit against the market supervision bureau [2] - The court found that the market supervision bureau had not effectively monitored compliance after issuing correction orders, leading to a ruling that confirmed the bureau's failure to fulfill its legal responsibilities [3] Group 3: Implications for Public Health - The case underscores the importance of regulatory bodies in ensuring the safe sale of prescription drugs and highlights the need for effective oversight to protect public health [3] - The involvement of the judiciary in addressing regulatory failures serves as a precedent for promoting lawful administration and safeguarding the health of the populace [3]

Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of enhancing drug regulation in 2024, focusing on creating a transparent and predictable regulatory environment to support pharmaceutical innovation and contribute to national economic development [1] Group 1: Drug Safety and Regulation - The NMPA aims to improve drug safety assurance levels and establish a robust drug safety responsibility system, including a regular risk consultation mechanism to address risks at an early stage [1] - There is a commitment to strengthen the regulation of key drugs, especially in light of the increased incidence of respiratory diseases during winter [1] Group 2: Support for Pharmaceutical Industry - The NMPA plans to enhance the quality and efficiency of drug review and approval processes, implementing tailored strategies for key products and supporting the development of innovative drugs and medical devices [1] - The agency will promote the coordinated development of the "three medical" sectors (medical insurance, medical care, and pharmaceuticals) and ensure the quality and efficacy consistency of generic drugs according to international standards [1] Group 3: Regulatory System and Capacity Building - There is a focus on strengthening the regulatory system and capacity, improving the legal and standard framework, and advancing smart regulation and regulatory science to modernize drug regulation [1] - The NMPA is tasked with planning key work for the upcoming year to ensure the successful completion of the 14th Five-Year Plan and a strong start to the 15th Five-Year Plan [1]