药品监管
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国家药监局:加强药品监管人才工作
Ren Min Wang· 2025-12-10 02:31
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。 ...
上海市药品监督管理局关于组织开展第十二个国家宪法日暨上海市第三十七届宪法宣传周活动的通知
Di Yi Cai Jing· 2025-12-04 06:52
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]
【省药监局】监管砺剑护民生 创新赋能筑高地
Shan Xi Ri Bao· 2025-12-02 22:34
"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 ...
国家药监局局长李利会见印尼食品药品管理局局长塔鲁那·伊克拉尔
Zheng Quan Shi Bao Wang· 2025-11-11 15:07
Core Points - The meeting between the head of China's National Medical Products Administration and the head of Indonesia's Food and Drug Authority focused on enhancing cooperation in drug regulation and clinical trials [1] - Both parties agreed to deepen regulatory exchanges and collaboration to promote the launch of high-quality pharmaceutical products benefiting the citizens of both countries [1] Group 1 - The discussion included topics such as multi-center clinical trials, production facility supervision, information technology development, and smart regulation [1] - The meeting signifies a commitment to improving drug regulatory frameworks and ensuring the safety and efficacy of medical products [1]
内蒙古鄂尔多斯市市场监管局强化麻精药品监管 筑牢药品安全防线
Zhong Guo Zhi Liang Xin Wen Wang· 2025-11-06 03:46
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]
聚焦“药品安全 监管为民”,多维度筑牢用药安全防线
Zhong Guo Shi Pin Wang· 2025-09-25 04:44
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]
【省药监局】陕西药品领域行政审批实现服务对象办事“零跑腿”
Shan Xi Ri Bao· 2025-09-17 00:30
Group 1 - The core viewpoint of the articles highlights the efforts of Shaanxi Province in streamlining drug regulatory processes, achieving "zero-run" services for clients through full online administrative approval and issuance of electronic licenses [1][2] - Since the beginning of the 14th Five-Year Plan, Shaanxi has reduced seven administrative service process nodes and optimized the handling processes for 12 items, leading to a 40% reduction in application materials and over 50% reduction in processing time [1] - The provincial drug regulatory authority has introduced a list of minor violations that will not incur administrative penalties, promoting a more inclusive and prudent regulatory approach [1] Group 2 - The provincial drug regulatory authority has actively engaged with 17 enterprises for on-site registration guidance, shifting from passive acceptance to proactive service, and has conducted administrative inspections at 1,060 enterprises [2] - Point-to-point assistance has been provided to over 20 enterprises, contributing to a continuously improving industrial development environment [2]
轮台县市场监管局开展校园“药品安全小课堂”
Zhong Guo Shi Pin Wang· 2025-09-12 04:23
Core Viewpoint - The article highlights the importance of drug safety education for young people, emphasizing the need for awareness regarding the risks associated with certain medications and the proper use of drugs in a school setting [1] Group 1: Event Overview - The event titled "Safe Medication in Schools" was organized by the Market Supervision Administration of Luntai County at the Sixth Primary School [1] - The activity aimed to strengthen the drug safety defense for teenagers by providing practical lessons on medication safety [1] Group 2: Educational Content - Law enforcement personnel acted as "safety mentors," using engaging formats like cartoons and short dramas to explain the potential risks of "internet-famous drugs" and "overseas purchased drugs" [1] - Students received a "Drug Safety Handbook" that outlined the principles of "following medical advice, reading instructions, and avoiding misuse" [1] Group 3: Interactive Engagement - The interactive area featured a "medication scenario simulation" that sparked lively discussions among students about topics such as "how to organize a family medicine cabinet" and "the difference between prescription and over-the-counter drugs" [1] - Real-life cases were used to illustrate the dangers of repeated medication use, and students were taught how to verify the authenticity of drugs using traceability codes [1] Group 4: Future Initiatives - The Market Supervision Administration of Luntai County plans to continue the "Drug Safety in Schools" initiative, aiming to involve families and the broader community in building a comprehensive drug safety network [1]
国家药监局局长李利会见新加坡卫生科学局局长蔡瑞文
Zheng Quan Shi Bao Wang· 2025-09-10 11:28
Core Points - The meeting between the heads of the National Medical Products Administration of China and the Health Sciences Authority of Singapore focused on enhancing mutual trust in drug and medical device regulation [1] - Both parties agreed to deepen practical cooperation in the field of drug regulation to improve the quality and efficiency of drug oversight [1] - The collaboration aims to better promote the health and well-being of the people in both countries [1]
国家药监局:科学制定“十五五”药品规划 全面深化药品审评审批制度改革
Zhong Zheng Wang· 2025-08-29 03:24
Core Viewpoint - The National Medical Products Administration emphasizes the importance of formulating the "14th Five-Year" drug planning to enhance drug regulation capabilities and promote high-quality development of the pharmaceutical industry, aiming to transition China from a major pharmaceutical country to a strong pharmaceutical nation [1] Group 1: Drug Regulation Development - The meeting highlighted the need to develop an overall strategy for drug regulation during the "14th Five-Year" period [1] - It aims to address deep-seated contradictions and issues in drug regulation, enhancing governance capabilities [1] - The focus is on creating a comprehensive drug safety responsibility system and a full-chain regulatory mechanism [1] Group 2: Reform and Innovation - There is a call for comprehensive deepening of drug review and approval system reforms [1] - The meeting encourages the innovation and development of traditional Chinese medicine and high-end medical devices [1] - It also emphasizes the need to reform the review and approval mechanisms for cosmetics to promote high-quality development [1] Group 3: Regulatory Capacity Building - The meeting stresses the importance of improving the regulatory standards and legal framework [1] - It highlights the need for strengthening technical support capabilities and leading with information technology [1] - The goal is to build a high-quality team of drug regulatory professionals to enhance overall regulatory capabilities [1]