Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of combining effective market mechanisms with proactive government support to enhance innovation in pharmaceuticals and medical devices, aiming to transform new medical technologies into productive forces [1][8]. Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, the drug regulation system has adhered to the "four strictest" requirements, leading to comprehensive reforms and a stable drug safety situation, thereby advancing the construction of a strong pharmaceutical nation [3]. - The NMPA has conducted over 200,000 drug inspections and 20,000 medical device inspections annually, improving the overall drug inspection pass rate from 97.8% during the 13th Five-Year Plan to 99.4% [3][4]. Group 2: Support for Innovation - The NMPA has approved 220 innovative drugs and 282 innovative medical devices since the 14th Five-Year Plan, which is 6.2 times and 3.1 times the number approved during the 13th Five-Year Plan, respectively [4]. - The NMPA aims to enhance the innovation capacity of the pharmaceutical industry by optimizing regulatory policies, focusing on original products and domestic alternatives to critical technologies [8][9]. Group 3: Future Measures for Drug Safety - The NMPA plans to shift drug safety management from a "passive defense" approach to "active prevention," enhancing risk management and collaboration across departments [6][7]. - The agency will implement a comprehensive drug safety responsibility system and improve the regulatory framework to ensure high-quality development in the pharmaceutical sector [6][10]. Group 4: Enhancing Public Welfare - The NMPA is committed to ensuring that regulatory reforms benefit the public, focusing on enhancing people's sense of gain, happiness, and safety [10][11]. - Efforts will be made to expedite the approval of urgently needed drugs, including those for rare diseases and pediatric use, while maintaining high standards and procedures [11][12].

Core Viewpoint - The article emphasizes the importance of drug safety and regulatory reforms in China, highlighting achievements during the 14th Five-Year Plan and outlining strategies for the 15th Five-Year Plan to enhance drug safety and support innovation in the pharmaceutical industry [1][2]. Achievements During the 14th Five-Year Plan - The national 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]. - 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 inspection pass rate increase from 97.8% to 99.4% [2][3]. Innovation and Development Support - A series of measures have been implemented to promote innovation in the pharmaceutical and medical device sectors, with 220 innovative drugs and 282 innovative medical devices approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3][4]. - The approval of 415 children's drugs and 155 rare disease drugs has further enhanced the vitality of innovation in the pharmaceutical industry [3]. Regulatory Capacity Enhancement - Revisions to key regulatory laws and the establishment of a comprehensive legal framework for drug regulation have been prioritized, alongside significant advancements in drug regulatory information technology [4]. - The establishment of specialized inspection centers and regional review centers has strengthened the capacity for drug regulation [4]. Transition to Proactive Drug Safety Management - The regulatory approach is shifting from "passive defense" to "active prevention," focusing on risk identification and responsibility enforcement to maintain drug safety [5][6]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [5]. Support for Innovative Drug and Medical Device Development - The regulatory body aims to enhance the clinical value and technological content of innovative drugs and medical devices, supporting enterprises in their research and development efforts [7]. - Policies will be optimized to facilitate faster market entry for innovative products, including the implementation of a national drug standard improvement plan [8]. Ensuring Public Benefit from Regulatory Reforms - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that the benefits of reforms reach all citizens [9]. - Efforts will be made to expedite the approval of urgently needed drugs and improve the quality and efficacy of generic drugs [9]. Strengthening Social Cooperation and Public Awareness - Increased efforts in policy interpretation and public education on drug safety and regulatory measures are planned to enhance societal understanding and support for innovation in the pharmaceutical sector [10].

随着互联网医疗、线上购药等新医疗模式不断普及，接下来还可能出现新的药品非法回流方式。比 如，药贩子利用线上平台的虚拟性，通过虚假账号、虚假订单等方式，骗取医保报销后将药品回流市 场。或者利用大数据分析，精准定位有药品出售需求的患者，实施更加精准的诱导和收购。随着医保跨 区域结算等政策的推进，药品的流通范围更广，不法分子还可能会利用区域间监管的差异和信息的不对 称，进行跨区域的药品非法回流活动。这些潜在的非法回流形式，对监管提出了更高要求。 "回流药"花样翻新，治理也要顺势应变。比如，针对日益增多的跨区域倒药行为，多地医保、公 安、市场监管等部门应建立信息共享、联合执法等机制，打破信息壁垒，实现从源头到终端的全链条监 管。针对利用互联网虚拟身份倒药行为，则要借助大数据、人工智能等技术，对医保报销数据、药品流 通数据等进行实时监测和分析，及时发现异常情况，提升精准度等。 近年来，一些人发现倒卖医保药品有利可图，以"医保取现""高价回收"等手段诱导参保人通过医保 报销渠道获取药品，再非法转手销售流入市场。这类医保"回流药"给用药人带来了直接的健康风险，并 严重侵害了国家医保基金的安全。媒体近日深入调查发现，医保"回 ...

Core Viewpoint - The rise of "internet celebrity drugs" has led to widespread concerns about their safety and efficacy, as many of these products lack proper regulation and can pose serious health risks to consumers [2][3][10]. Group 1: Overview of "Internet Celebrity Drugs" - Various "internet celebrity drugs" have gained popularity, including weight loss pills, whitening capsules, and vision-correcting eye drops, often promoted through social media and live-streaming platforms [1][3]. - Many of these drugs are marketed with exaggerated claims, leading to misuse and adverse health effects, such as malnutrition and hypoglycemia [3][4]. Group 2: Marketing Tactics - The marketing strategies for these drugs often include sensationalized advertising that preys on consumer anxieties, particularly among vulnerable populations [6][7]. - Some prescription medications are rebranded as "internet celebrity drugs," misleading consumers about their intended use and potential side effects [4][5]. Group 3: Regulatory Challenges - There are significant gaps in the regulation of online drug sales, allowing consumers to easily purchase prescription medications without proper oversight [5][10]. - Recent investigations have revealed numerous cases of illegal advertising and the sale of fake "miracle drugs," highlighting the need for stricter enforcement of existing laws [8][10]. Group 4: Recommendations for Improvement - Experts suggest enhancing the drug regulatory framework, improving medical education, and increasing the accountability of online platforms to prevent the spread of misleading health information [10][11]. - There is a call for better collaboration between regulatory bodies and healthcare professionals to ensure accurate medical guidance is available to the public [10][11].

无需节食运动的减肥药、一吃就白的美白丸、可矫正视力的眼药水……近年来，不少"网红药"风靡市场。直播间内的"限时抢购"、社交平台上 的"种草攻略"、朋友圈里的"熟人背书"，吸引网民跟风购买。 在网络购物平台上，各类"网红药"热销。（受访者供图） 这些"网红药"靠谱吗？热销背后有啥猫腻？记者进行了调查。 多种"神药"在网络泛滥 为了减到"完美体重"，成都市民游女士近期大量服用在社交平台上走红的某款减肥药，但却出现营养不良、低血糖等不良反应，晕倒过好几次。 近年来，类似"网红药"滥用引发不良后果的案例屡见不鲜。记者在社交平台、电商平台等搜索发现，从减肥药到鼻喷药，从眼药水到"治癌秘 方"，打着各种名头的"网红药"在网上热销。然而仔细观察配图中的药品包装，有的生产厂家、名称等信息不全，有的号称是"进口药"却没有药品 批准文号。 业内人士指出，这些"网红药"有的是有一定功效的保健品，但被炒作成治病"神药"；还有的是未经国内临床验证及批准进口的"海淘"药，安全性 存疑。这些药一旦被滥用，可能危害生命健康。 不仅如此，一些处方药经过营销包装后，也摇身一变成为"网红药"。 "考试前吃了一颗，感觉脑子也很清晰，就是事后有点嗜睡 ...

Core Viewpoint - During the "14th Five-Year Plan" period, China has approved 210 innovative drugs for market entry, with a focus on ensuring drug safety and efficacy through stringent regulations and quality management in drug development and production [1][2]. Group 1: Innovative Drug Approval and Market Entry - In the first eight months of this year, China approved 56 innovative drugs, surpassing the total of 48 from the previous year, indicating a rapid growth trend in innovative drug approvals [1][2]. - The National Medical Products Administration (NMPA) has established four expedited pathways for innovative drugs, including breakthrough therapy designation and conditional approval, to accelerate the drug approval process [2][7]. Group 2: Quality Management in Drug Development - The NMPA has implemented strict regulations for new drug development, requiring confirmation of chemical structures, animal testing, and rigorous clinical trials to ensure safety and efficacy before market approval [4][5]. - Companies like Shanghai Junshi Biosciences have successfully launched multiple innovative drugs, focusing on unmet clinical needs and maintaining a robust research and development team to ensure reliable drug development [5][6]. Group 3: Post-Market Surveillance and Risk Management - The NMPA emphasizes the importance of post-market surveillance to ensure drug quality and safety, requiring drug holders to establish comprehensive quality assurance systems and conduct thorough reviews of production processes before market release [8][9]. - A specialized mechanism for monitoring adverse drug reactions has been established to promptly identify and manage safety risks associated with newly launched innovative drugs [9].

据外媒报道，FDA美国食品药物管理局发言人向媒体证实，Richard Pazdur, M.D.在被任命为美国最高药品 监管机构负责人仅3周后，正着手辞去 FDA 药物评价与研究中心（CDER）主任一职。 Richard Pazdur自 2017 年 FDA 肿瘤卓越中心成立以来一直担任该中心主任，起初似乎并不愿意接任 CDER 主任一职。据多家媒体报道称，他最初曾拒绝了这一任命。但据《华盛顿邮报》消息，FDA 局长 Marty Makary, M.D.及其他高级官员坚持要求他接受该职位。 据外媒报道，FDA美国食品药物管理局发言人向媒体证实，Richard Pazdur, M.D.在被任命为美国最高药品 监管机构负责人仅3周后，正着手辞去 FDA 药物评价与研究中心（CDER）主任一职。 该发言人表示："我们尊重Richard Pazdur博士的退休决定，并向他在 FDA26 年的杰出服务致敬。作为肿 瘤卓越中心（Oncology Center of Excellence）的创始主任，他留下了跨中心监管创新的宝贵遗产，既强化 了机构职能，也为无数患者改善了医疗服务。他的领导力、远见卓识和奉献精神将在未来多年持 ...

Core Points - The article emphasizes the ongoing efforts of drug regulatory authorities in Gansu Province to enhance drug safety and combat illegal activities in the pharmaceutical sector [2] - It highlights the enforcement actions taken against several companies for violations of drug management laws [3][4][5][6] Summary by Category Regulatory Actions - Gansu Province's drug regulatory departments are implementing decisions from higher authorities to strengthen drug safety and regulation [2] - A series of typical cases of illegal activities in the pharmaceutical sector have been disclosed to the public [2] Case Summaries 1. **Tianshui Xinguang Pharmaceutical Co., Ltd.**: The company was penalized for selling drugs with false sales records, resulting in a confiscation of illegal gains amounting to 1,159.8 yuan and a fine of 110,000 yuan [3] 2. **Xianheimai**: This entity was found to be producing and selling drugs without the necessary licenses, leading to the confiscation of illegal gains of 11,850 yuan and a fine of 25,875 yuan [3] 3. **Jiuquan City Jiuyi Pharmacy**: The pharmacy submitted false materials to obtain a drug business license, resulting in the revocation of its license and a fine of 20,000 yuan [4] 4. **Zhangye Shanai Hospital**: The hospital was found using expired medical devices, leading to the confiscation of the devices and illegal gains of 49,554 yuan [5] 5. **Minle County Li Wenhui Cosmetics Store**: The store was penalized for selling expired cosmetics, resulting in the confiscation of the products and a fine of 2,000 yuan [6]

Core Insights - The National Medical Products Administration (NMPA) held a meeting to convey the spirit of the 20th Central Committee's Fourth Plenary Session, focusing on drug regulation reforms and safety measures [1] Group 1: Leadership and Governance - The meeting emphasized the importance of strengthening the leadership and construction of the Party, ensuring adherence to the "two establishments" and "two safeguards" [1] - It highlighted the need for consistent implementation of General Secretary Xi Jinping's directives on drug regulation and the Party's decision-making regarding drug supervision [1] Group 2: Drug Safety Regulation - There is a focus on enhancing the entire chain of drug safety regulation, improving the drug safety responsibility system, and establishing a risk consultation mechanism [1] - The NMPA aims to strengthen oversight in key areas and combat illegal activities to maintain drug safety and stability [1] Group 3: Regulatory Reforms - The NMPA plans to deepen drug regulation reforms by enhancing communication throughout the entire process of clinical trials, registration, inspection, and review [1] - Support for the development of innovative drugs and medical devices is a priority [1] Group 4: Collaborative Development - The meeting stressed the importance of promoting the coordinated development of the "three medicines" (medical insurance, medical services, and pharmaceuticals) [1] - Efforts will be made to optimize drug procurement and support the innovation and inheritance of traditional Chinese medicine [1]

Core Viewpoint - Hims&Hers Health's stock price declined over 7% to $49.99 following a formal warning from the FDA regarding the promotion of its compounded semaglutide product, which has not been approved by the agency [1] Regulatory Issues - The FDA emphasized that the compounded drug product is not equivalent to standard medications that have undergone clinical trials and approval [1] - Hims&Hers is required to submit corrective actions within 15 business days, or it may face legal sanctions including product seizures and injunctions [1]