新华社北京12月10日电 题：以高效严格监管促进创新药和医疗器械发展——访国家药品监督管理局党 组书记、局长李利 新华社记者赵文君、戴小河 药品是治病救人的特殊商品，保障药品安全有效是严肃的政治问题、基本的民生问题、重大的经济问 题、严谨的技术问题。党的二十届四中全会审议通过的《中共中央关于制定国民经济和社会发展第十五 个五年规划的建议》（以下简称《建议》）对加强药品安全工作，支持创新药和医疗器械发展等提出明 确要求。 "十四五"以来，我国药品监管事业取得了哪些成效？"十五五"时期，如何切实维护药品安全？如何鼓励 支持医药企业研发创新，推动实现药品高水平安全和医药产业高质量发展良性互动？新华社记者采访了 国家药品监督管理局党组书记、局长李利。 推动制药强国建设迈出坚实步伐 问："十四五"以来，我国药品监管事业取得哪些成效？ ——持续深化改革，促进产业创新发展。制定出台全面深化药品医疗器械监管改革的系列措施，制定 《国家药监局关于深化化妆品监管改革促进产业高质量发展的意见》，支持化妆品原料技术创新。"十 四五"以来，批准上市创新药220个、创新医疗器械282个，分别达到"十三五"期间的6.2倍、3.1倍。批准 ...

"十四五"时期，是陕西省药品监管事业在新时代新征程上迈出坚实步伐的关键五年。五年来，省药 品监督管理局深入贯彻落实党中央决策部署和习近平总书记历次来陕考察重要讲话重要指示，坚持党的 全面领导，以深化开展"三个年"活动为工作抓手，以"四个最严"要求为根本遵循，紧紧围绕"讲政治、 强监管、保安全、促发展、惠民生"工作思路，以党建领航定向，以监管筑牢防线，以创新驱动发展， 以服务赋能产业，交出了一份药品安全形势稳定向好、医药产业活力迸发的亮眼答卷，为筑牢三秦百姓 健康屏障、服务全省经济社会高质量发展作出了积极贡献。 党建引领 锻造忠诚干净担当药监铁军 全面建设社会主义现代化国家，全面推进中华民族伟大复兴，关键在党，关键在人。"十四五"以 来，省药监局始终将坚持和加强党的全面领导贯穿于药品监管工作全过程、各方面，着力锻造一支让党 放心、让人民满意的药品安全监管铁军，以更高标准、更严要求、更实作风为药品监管现代化保驾护 航。 强化理论武装，筑牢思想根基。坚持把理论学习作为党员干部"必修课"，严格落实"第一议题"制 度，制定党组理论学习中心组年度学习计划，按季度组织集中学习和专题研讨，充分发挥领导班子"头 雁效应"。深入 ...

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]

Core Viewpoint - The Heze Luxi New Area has made significant progress in drug safety regulation and industry development, addressing public concerns and enhancing safety awareness through various initiatives [1][5]. Group 1: Drug Safety Regulation - The Luxi New Area has implemented a dual approach of "promotion + training" to enhance public and industry personnel's safety awareness, conducting multiple public outreach events and training sessions [2]. - A comprehensive regulatory system has been established, focusing on risk management and local oversight, with over 1,600 law enforcement personnel deployed to inspect 463 drug operating units this year [3]. - The "Code for Assurance" platform has achieved a 100% registration rate for drug operating units, ensuring traceability and quality control of drugs [3]. Group 2: Industry Development - The biopharmaceutical industry is a key sector in the Luxi New Area, with several major projects completed and new investments signed, totaling 7.51 billion yuan this year [4]. - The area has facilitated the growth of retail pharmacy chains, with 282 drug retail enterprises and a chain rate of 86%, promoting scale and efficiency in the industry [5]. Group 3: Public Engagement and Compliance - The Luxi New Area has strengthened online drug sales regulation, achieving a 100% inspection coverage of 149 online sales enterprises, while advising consumers to purchase from legitimate platforms [5]. - Future efforts will focus on enhancing regulatory services and encouraging public participation in drug safety governance, fostering a collaborative environment for high-quality industry development [5].

Core Viewpoint - The Ordos Market Supervision Administration is implementing multiple measures to strengthen the supervision and management of narcotic and psychotropic drugs, ensuring public safety and health [1][2] Group 1: Regulatory Actions - The "Qingyuan 2025" special action plan has been developed to clarify the focus and division of tasks for the supervision of narcotic and psychotropic drugs [1] - There is an emphasis on enhancing supervision of special drug raw materials and outpatient treatment for drug addiction, preventing illegal circulation of these drugs [1] - Comprehensive inspections of drug operating and using units are being conducted, focusing on the qualifications, sales channels, storage conditions, and usage records of narcotic drugs [1] Group 2: Risk Management - A risk consultation meeting has been organized to identify risk points in the circulation and use of narcotic drugs, leading to the formulation of targeted control measures [1] - Ongoing monitoring and special rectification efforts are being strengthened, particularly in medical institutions regarding the management of narcotic drugs and monitoring of drug abuse [1] - As of now, 327 medical institutions have been inspected, with 825 law enforcement personnel deployed to address issues related to expired narcotic drugs [1] Group 3: Online and Offline Monitoring - There is a continuous effort to monitor and combat the illegal online sale of narcotic drugs, with both online inspections and third-party monitoring being conducted [2] - No illegal sales of narcotic drugs through the internet have been found in the Ordos area to date [2] - Future actions will include enhancing follow-up inspections of medical institutions, improving risk prevention mechanisms, and strengthening online regulatory measures [2]

Core Viewpoint - The article emphasizes the importance of drug safety in rural areas and outlines measures taken by the Shawan City Market Supervision Administration to enhance drug safety and protect public health [1][2]. Group 1: Regulatory Measures - The Shawan City Market Supervision Administration has implemented a three-pronged regulatory model of "daily supervision + special rectification + smart regulation" to increase inspection frequency and intensity for rural drug businesses [1]. - Key areas of focus include the inspection of expired drugs and counterfeit products, with a full-chain supervision approach covering procurement, storage, and sales [1]. - The administration aims to create a high-pressure environment for illegal activities by ensuring that every violation is discovered and dealt with promptly [1]. Group 2: Service Improvement - Efforts are being made to enhance drug accessibility by guiding chain pharmacies to expand supply channels in rural areas, allowing residents to purchase safe and affordable medications locally [2]. - Training programs for drug businesses are being conducted to improve the standardization of drug storage and sales practices, as well as to enhance the professional skills of staff [2]. Group 3: Community Engagement - The article highlights the importance of public participation in drug safety, with regular outreach activities to educate the community about drug safety laws and regulations [2]. - A collaborative governance model is being promoted, involving regulatory authorities, business self-discipline, and public participation to eliminate counterfeit drugs in rural areas [2]. Group 4: Future Directions - The Shawan City Market Supervision Administration plans to continue focusing on weak links in rural drug safety, improving regulation, enhancing services, and strengthening public awareness [2]. - The goal is to ensure that rural residents feel a greater sense of security, happiness, and satisfaction regarding drug safety [2].

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]

Group 1 - The core theme of the article is "Drug Safety and Regulation for the People," focusing on integrating drug safety knowledge dissemination with drug safety rectification efforts [1] - The initiative includes outreach to schools, communities, and enterprises to enhance public awareness of drug safety [1] - The approach involves interactive methods such as storytelling and Q&A sessions in schools, practical examples in communities, and integrating safety education into regulatory inspections in enterprises [1] Group 2 - The next steps involve deepening the integration of drug safety promotion with daily regulatory practices, ensuring that supervision and public education are synchronized [1] - The goal is to extend the reach of drug safety education to all areas where regulation occurs, reinforcing the message that "where regulation extends, promotion will cover" [1] - This strategy aims to strengthen drug safety measures and create a solid foundation for maintaining a good drug safety environment [1]

Core Viewpoint - The article highlights the efforts of the Yuhang District Market Supervision Administration to enhance drug safety regulation in small pharmacies, clinics, and beauty shops, focusing on protecting public health through targeted governance measures [1][2]. Group 1: Regulatory Measures - The Yuhang District Market Supervision Administration has initiated a special governance campaign targeting "three smalls" (small pharmacies, small clinics, small beauty shops) to address drug safety concerns [1]. - A dynamic electronic file system has been established for 1,155 "three smalls" units, including 313 small pharmacies, 182 small clinics, and 660 small beauty shops, integrating various regulatory data for precise monitoring [2]. - The administration has identified 79 key regulatory targets, increasing the frequency and rigor of inspections for these entities [2]. Group 2: Compliance and Rectification - A closed-loop mechanism has been created, consisting of a subject information list, problem list, and rectification list, ensuring that all issues are tracked and resolved online [4]. - The administration has conducted eight inspection campaigns, resulting in legal penalties for 30 entities, including 14 beauty shops, 9 clinics, and 7 pharmacies, to enforce accountability [4]. - A total of 132 identified issues have been fully rectified, demonstrating the commitment to drug safety [4]. Group 3: Support for Operators - The Yuhang District has organized training and collective discussions for over 400 operators of "three smalls," clarifying key regulations such as the Drug Administration Law and negative lists [4]. - The administration has implemented measures to strengthen social supervision, including signing responsibility agreements and providing public reporting channels [4]. - The approach combines digital governance with human-centered guidance to foster trust in drug safety [4].

Core Viewpoint - The National Medical Products Administration (NMPA) announced the "National Drug Safety Publicity Week" for 2025, scheduled from September 1 to 7, with the theme "Drug Safety Regulation for the People" [1] Group 1 - The 2025 event marks the end of the 14th Five-Year Plan and signifies a new phase in deepening drug regulatory reforms [1] - The focus will be on showcasing the achievements of drug regulation since the establishment of the NMPA, particularly during the 14th Five-Year Plan period [1] - The initiative aims to enhance public trust and support for drug regulation efforts, emphasizing high-level safety and the promotion of high-quality development in the pharmaceutical industry [1] Group 2 - The campaign will include extensive public education on the safety of "two drugs and one device" (referring to drugs and medical devices), utilizing various formats to disseminate related scientific knowledge [1] - The goal is to improve public scientific literacy and foster a collaborative atmosphere for shared governance in drug safety [1]