来源：新华社 中国政府网 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》 新华社北京1月27日电 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 ...

下一步，我县将持续加强节日期间药品安全巡查与应急值守，畅通投诉举报渠道，确保人民群众度过一 个平安祥和的春节。 为保障春节期间群众用药安全，规范药品市场秩序，近日，额敏县市场监督管理局联合公安局、卫健 委，对辖区内药品零售企业、医疗机构等经营使用单位开展了春节前专项监督检查。 （供稿：宋世淇 ） 一是聚焦关键环节，排查风险隐患。此次检查深入药店、卫生院等场所，重点排查药品购进渠道合法 性、储运条件合规性、处方药销售管理规范性等关键风险点，严厉打击非法渠道购销、储运不当、违规 销售处方药等行为。二是突出检查重点，确保用药安全。检查中，执法人员着重查看感冒发热、消化道 疾病等节期高发疾病常用药品，以及慢性病用药、特殊管理药品的质量安全状况，并仔细核对供货方资 质、随货同行票据、验收记录，核查药品储存温湿度检测仪是否定期校准，督促各单位严格落实主体责 任，严防假冒伪劣、过期失效药品流入市场。三是强化执法协作，督促立行立改。此次行动充分发挥部 门联动优势，形成监管合力。对检查中发现的个别单位温控设备未及时校准、药品分类管理不到位等问 题，现场提出整改意见并责令立即改正。同时，向从业人员宣贯药品安全法律法规，提升其守法 ...

针对流感季节重点品种药品的检查，重点查看药店治疗感冒、消炎类药品是否出现短缺情况，是否能够 全力满足消费者购药用药需求。提示药店积极应对，根据药店自身经营模式，及时补充库存，重点补充 冬季呼吸道疾病的相关药物。严格执行凭处方药销售、执业药师在岗等要求，确保药品市场稳定有序。 下一步，平谷区市场监管局将持续加大药品安全监管力度，落实监管责任，督促药店落实主体责任，加 强安全风险管控，确保人民群众用药安全。（来源：平谷市场监管） 针对医保药店的检查，执法人员重点通过三个关键环节展开：一是药品购进渠道、资质、票据情况，包 括对企业购进药品渠道、上游企业的资质核验，采购及销售票据是否齐全，票、账、货、款是否一致 等；二是落实凭处方销售处方药要求情况，包括检查企业是否伪造处方，是否不凭处方销售处方药，是 否不审核处方销售处方药等；三是网络销售情况，包括核验是否符合"线上线下一致"原则，是否按要求 审核处方，发货地址与经营地址是否一致，是否按要求配送药品等。 中国质量新闻网讯 为进一步从严从实从细做好药品安全的监管工作，营造良好经营环境，北京市平谷 区市场监管局药品和化妆品监管科对辖区内的药品经营企业进行检查。本次检查重 ...

积极拓展宣传渠道，丰富宣传内容，着力提升公众"两品一械"安全意识，推动形成社会共治良好氛围。 一是开展集中宣传活动。以"安全用药月""化妆品安全科普宣传周"等活动为契机，通过设置咨询台、发 放科普手册、开展专家义诊等形式，深入社区、乡村、学校开展宣传活动8场，覆盖群众2万余人次，发 放宣传资料4万余份。二是加强线上宣传普及。利用官方网站、微信公众号等平台，发布法律法规解 读、安全使用常识、风险警示信息等60余条，阅读量达1.5万余次，及时回应社会关切。三是强化企业 主体责任教育。组织开展企业负责人和质量管理人员专题培训，通过"以案说法"的方式讲解典型违法案 例，强化企业合规经营意识，全年培训企业人员120余人次，推动企业落实质量安全主体责任。（供 稿：青海省市场监管局） 始终将基础建设作为提升监管效能的关键抓手，不断完善监管体系、强化队伍能力。一是提升队伍专业 素养。围绕《中华人民共和国药品管理法》《医疗器械监督管理条例》及《化妆品监督管理条例》等法 律法规和标准规范，组织开展专题培训4场，内容涵盖现场检查技巧、案件查办要点、电子化追溯系统 实操等核心内容，参训人员达150余人次。通过"理论+实操"的培训模式 ...

Core Viewpoint - The national drug supervision work conference emphasized key tasks for 2026 to ensure a good start for the "14th Five-Year Plan," focusing on drug safety, industry development, legal standards, and modernization of drug regulation [1] Group 1: Drug Safety - The conference highlighted the need to ensure high-level drug safety by improving the drug safety responsibility system and enhancing clinical trial supervision [1] - There will be increased inspection and sampling efforts on key varieties, especially those selected in centralized procurement [1] - The initiative includes a "clean source" action in drug distribution and strengthened regulation of online sales to maintain drug safety standards [1] Group 2: Industry Development - The conference aims to support the pharmaceutical industry in improving quality and efficiency through comprehensive reform of drug regulation [1] - It emphasizes early intervention and tailored strategies for key products, promoting innovation in drug research and development [1] - The focus also includes supporting the self-reliance of high-level medical devices and fostering the growth of the beautiful economy [1] Group 3: Legal Framework - Continuous improvement of the drug regulation legal framework is a priority, including enhancing the authority and credibility of administrative law enforcement [1] - There will be increased legal education efforts directed at enterprises and grassroots levels to solidify the legal foundation of drug regulation [1] Group 4: Modernization of Drug Regulation - The conference calls for high-quality development of the "14th Five-Year" drug planning and the promotion of integrated national drug regulation [1] - Strengthening the regulatory talent pool and technical support capabilities is essential, along with advancing regulatory information technology and scientific research applications [1] - The initiative aims to enhance China's international influence in drug regulation and participate actively in global drug safety governance [1]

下一步，乌苏市市场监管局将严格落实"四个最严"要求，坚持专项整治与日常监管相结合，持续加大药 品监管力度，深入排查风险隐患，对违法违规行为保持"零容忍"态势，全力保障节日期间药品质量安 全，守护人民群众用药安全。（杜志锋、王林、江恩里） 岁末年初，新疆维吾尔自治区乌苏市市场监管局强化党建引领，积极践行"实干争先"理念，分管领导带 队对部分重点区域的药品零售企业、连锁门店开展节前药品安全检查，全面筑牢节日用药安全防线。 此次检查，该局执法人员通过塔通办·扫码检查方式，严格对标药品经营质量管理规范（GSP），对药 店的药品购进渠道、储存条件、处方药销售管理、执业药师在岗履职、药品价格公示及近效期药品处理 等关键环节进行细致入微的实地查验和现场问询。与企业负责人、执业药师及一线员工进行深入交流， 仔细了解企业经营状况、药品采购渠道、质量管控流程、人员培训以及当前面临的困难与诉求，并认真 听取了加强监管指导的意见建议。同时指出，药品安全是重大民生问题，关乎人民群众生命健康和社会 和谐稳定。药品经营企业作为药品流通环节的关键主体，必须时刻绷紧安全这根弦，坚守法律底线和道 德红线。截至目前，该局检查药店7家，发现安全问题 ...

Core Viewpoint - The Xinjiang Production and Construction Corps (XPCC) has launched a "Clean Source Action" to address prominent issues in the pharmaceutical distribution sector, focusing on comprehensive inspections and strict regulatory measures to enhance drug safety and compliance [1] Group 1: Regulatory Actions - The "Clean Source Action" involves a thorough inspection of pharmaceutical business practices, with a focus on risk assessment and enforcement of regulations [1] - Regulatory authorities have inspected 2,453 pharmaceutical enterprises at both the XPCC and division levels, mandating timely rectification of identified violations [1] Group 2: Focus Areas of Inspection - Inspections target key issues such as unauthorized business operations, procurement from illegal sources, tampering with computer system data, and failure to upload or verify drug traceability codes [1] - Multiple regulatory measures have been implemented to address industry irregularities, aiming to purify the pharmaceutical market environment and strengthen drug safety defenses [1]

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] Group 1: Achievements During the 14th Five-Year Plan - The drug regulatory system in China has adhered to the "four strictest" requirements, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2] - Continuous strengthening of regulation has ensured drug quality and safety, with over 200,000 batches of drugs and 20,000 batches of medical devices tested annually, resulting in an overall drug sampling pass rate increase from 97.8% to 99.4% [2] Group 2: Industry Innovation and Development - A series of measures have been implemented to deepen the reform of drug and medical device regulation, resulting in the approval of 220 innovative drugs and 282 innovative medical devices, which are 6.2 times and 3.1 times higher than during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs has further enhanced the vitality of innovation in the pharmaceutical industry [3] Group 3: Regulatory Capacity Enhancement - The establishment of a relatively complete legal system for drug regulation has been achieved, with the issuance of the 2025 edition of the Pharmacopoeia of the People's Republic of China and numerous standards for traditional Chinese medicine and medical devices [4] - Significant progress has been made in the informatization of drug regulation, with the establishment of key laboratories and the implementation of 59 major projects in regulatory science [4] Group 4: Future Measures for Drug Safety - The NMPA plans to enhance drug safety management by shifting from "passive defense" to "active prevention," improving the risk prevention and control capabilities [5] - A dynamic safety supervision mechanism covering the entire lifecycle of drugs will be established, focusing on clinical trials, commissioned production, and online sales [6] Group 5: Support for Innovative Drug and Medical Device Development - The NMPA will support enterprises in strengthening the research and development of innovative drugs and medical devices, emphasizing policy guidance and resource allocation for original products and domestic alternatives [7] - Efforts will be made to accelerate the listing of innovative drugs and medical devices by optimizing registration processes and enhancing intellectual property protection [8] Group 6: Ensuring Public Benefit from Regulatory Reforms - The NMPA aims to ensure that regulatory reforms benefit the public by enhancing access to essential drugs and maintaining high standards for generic drugs [9] - Collaboration with health and insurance departments will be strengthened to improve drug traceability and ensure the safety and effectiveness of medications [10]

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]

Core Insights - The article emphasizes the continuous improvement of drug safety regulation and the support for the biopharmaceutical industry in the Luwest New Area [1] Group 1: Regulatory Enhancements - The Luwest New Area's Comprehensive Administrative Law Enforcement Bureau has focused on problem-oriented and result-oriented approaches to strengthen drug regulation capabilities [1] - A "Clear Source Action" was conducted to identify over 10 types of illegal activities, involving 1,600 law enforcement personnel and inspecting 463 businesses [4] - The "Code for Reassurance" platform achieved a 100% entry rate, with 77 adverse reaction reports completed, ensuring traceability of drug sources and destinations [4] Group 2: Industry Support - Key projects such as the expansion of Buchang Weixin and Danhong series are being completed, with 11 new pharmaceutical projects signed, totaling an investment of 7.51 billion [6] - The drug retail chain rate reached 86%, and 100% coverage of inspections for 149 online pharmaceutical companies was achieved [9] Group 3: Future Directions - The next steps include strengthening regulatory compliance, enhancing regulatory service capabilities, engaging the public in social governance, and continuously supporting high-quality development of the pharmaceutical industry [10]