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全力守护节日市场平安稳定
Xin Lang Cai Jing· 2026-02-23 20:40
在食品安全监管方面,以散装直接入口食品、酒水、粮油等应节热销食品为重点品种,对临时摊点、农 贸市场、商场超市、农村牧区为重点场所开展专项检查。检查食品经营单位160余家次、大中型商超12 家次,发布消费提示1条,发放宣传资料400余份,现场督促整改问题9个。 据介绍,黄南州持续加大市场巡查力度,紧盯重点领域、重点场所开展"回头看"检查,严格落实节日期 间24小时值班和领导带班制度,畅通12315投诉举报渠道,严守安全底线,全力保障春节期间市场秩序 稳定、群众安心过节。 药品安全监管领域,聚焦基层药品、医疗器械、化妆品经营使用单位,重点加强高风险药品、第三类医 疗器械、特殊化妆品监督检查,严格核查购进验收、储存销售等环节,督促执业药师在岗履职,全力保 障节日药械化市场供应安全。 本报黄南讯 (记者 芈峤) 2月23日,记者从黄南藏族自治州市场监督管理局获悉,春节期间黄南州聚 焦食品药品、重点产品质量、特种设备等关键领域,从严从细落实监管举措,全力保障节日市场秩序稳 定、消费环境安全,切实做好市场监管领域安全防范工作。 此外,加强计量衡器监管,以农贸市场、商场超市、加油站等为重点,严查未经检定、超期未检、计量 作 ...
省药品监管局开展节前药品安全检查
Xin Lang Cai Jing· 2026-02-13 18:33
省药品监管局将以此次节前检查为契机,聚焦危化品管理、消防安全、特种设备运行等重点领域,深入 开展风险隐患大排查大整治,对排查出的问题隐患建立台账、限期整改、闭环管理。督促企业健全日常 安全管理制度,加强员工安全培训和应急演练,持续提升企业本质安全水平。密切关注节日期间药品市 场供应和紧急突发事件处置保障工作,确保常用药、急救药供应不断档、价格不上涨,全力保障群众节 日用药安全。 检查组深入易燃易爆危化品储存区,仔细核查易制毒化学品管理台账与安全防控措施落实情况;在酒精 储罐区,重点检查防泄漏报警装置运行状态及应急处置准备工作;在化妆品门店,详细查看产品注册备 案手续、进货渠道资质及批发销售记录。针对检查中发现的安全隐患,现场提出明确整改要求,督促立 即整改到位。 本报讯 (记者 郭靓) 2月12日,青海省药品监督管理局深入国药普兰特(青海)药业有限公司、天域 (青海)科技创新有限公司、泰阳国际批发市场等企业,直插生产仓储、批发零售一线,督导检查"两 品一械"安全生产工作,筑牢节日用药安全防线。 ...
吉林市丰满区开展节前药品安全检查
Xin Lang Cai Jing· 2026-02-10 00:32
Core Viewpoint - The Jilin City Market Supervision Administration's Fulfilling Branch is conducting a comprehensive drug safety inspection ahead of the Spring Festival to ensure public safety in medication use during the holiday season [1][2]. Group 1: Inspection Focus - The inspection targets key areas such as large medical institution pharmacies, retail pharmacies, clinics, and township health centers in densely populated regions, particularly around tourist attractions [1]. - Seasonal hot-selling drugs like antipyretics, cough suppressants, gastrointestinal regulators, as well as prescription and chronic disease medications are the main focus of the inspection [1]. Group 2: Regulatory Measures - Regulatory personnel are verifying drug procurement channels, supplier qualifications, purchase invoices, and acceptance records to ensure traceability and quality assurance of drugs [1]. - The inspection includes checking the operation of refrigeration cabinets and temperature and humidity monitoring equipment, correcting improper drug storage practices to prevent deterioration [1]. Group 3: Compliance and Education - The inspection also addresses illegal practices such as "hanging licenses" for pharmacists and the sale of prescription drugs without prescriptions, ensuring compliance with prescription review protocols [1]. - Regulatory personnel are actively educating both industry professionals and consumers about relevant laws and regulations regarding drugs and medical devices, particularly focusing on vulnerable groups [1].
河北省阳原县市场监管局开展节前药品检查
Xin Lang Cai Jing· 2026-02-09 08:56
Core Viewpoint - The article highlights the proactive measures taken by the Yangyuan County Market Supervision Administration in Hebei Province to ensure drug safety during the upcoming Spring Festival by conducting a special inspection of the pharmaceutical market [1] Group 1: Inspection Focus - The inspection primarily targets retail pharmacies, focusing on commonly used medications during the festival, such as cold and fever remedies, health supplements, and emergency drugs [1] - Key areas of scrutiny include drug procurement channels, storage conditions, and expiration date management [1] Group 2: Compliance and Enforcement - The inspection emphasizes the enforcement of regulations regarding prescription drug sales and the presence of licensed pharmacists on duty [1] - Issues identified during the inspection, such as non-compliant record-keeping and untimely temperature and humidity documentation, were addressed on-site with immediate rectification orders [1] Group 3: Safety Measures and Future Actions - The inspection has contributed to the regulation of the local pharmaceutical market and the identification of potential drug safety hazards [1] - The Yangyuan County Market Supervision Administration plans to increase inspection efforts leading up to the festival, ensure follow-up on problem rectifications, and maintain open channels for complaints and reports [1]
让中成药安全的“标尺”更清晰
Xin Lang Cai Jing· 2026-01-30 17:41
Core Viewpoint - Recent regulatory requirements for traditional Chinese medicine (TCM) aim to enhance the safety and clarity of drug information, addressing consumer concerns about the potential elimination of many TCM products [1][2] Group 1: Regulatory Changes - Starting from July 1, 2026, TCM products with unclear contraindications, adverse reactions, and precautions will not be approved for re-registration, raising the standards for TCM safety [1] - The new regulations will end the previous system where TCM approvals were only additive, promoting a competitive environment that prioritizes quality over quantity [2] Group 2: Industry Impact - The requirement for clearer labeling will provide scientific guidance for doctors and improve public awareness of medication risks, thereby enhancing the overall safety of TCM usage [1] - The regulatory changes are expected to drive a systemic transformation across the entire TCM industry, from drug labeling to pricing and production standards, fostering a shift towards evidence-based practices [2] Group 3: Corporate Responsibility - Companies are now compelled to take greater responsibility for drug safety and efficacy, necessitating the improvement of safety data and the revision of product information [1] - The emphasis on quality and safety will encourage TCM enterprises to strengthen post-market research and ensure compliance with updated standards [1][2]
“大批中成药将退出市场”是真的吗?
Sou Hu Cai Jing· 2026-01-30 13:02
Core Viewpoint - The recent implementation of the "Regulations on the Registration Management of Traditional Chinese Medicine" by the National Medical Products Administration is expected to significantly impact the market for traditional Chinese medicine, with a potential exit of many products by 2031 due to stricter requirements for drug registration and safety information [1][2][5]. Group 1: Policy Implementation and Timeline - The new regulations took effect on July 1, 2023, providing a transition period of three years, with an actual deadline for compliance extending to 2031 due to the five-year drug re-registration cycle [1][5]. - Many companies, including leading firms like Yunnan Baiyao and Tongrentang, are already preparing to meet the new requirements by enhancing their product safety information [1][5]. Group 2: Rationale Behind the Policy - The policy aims to improve drug safety by mandating that traditional Chinese medicine products clearly state contraindications, adverse reactions, and precautions, addressing public concerns about medication safety [2][4]. Group 3: Market Impact and Industry Dynamics - The regulations are not expected to lead to a mass exit of traditional Chinese medicine products; instead, they may encourage companies to focus on their core strengths and improve product quality [4][5]. - The Chinese traditional medicine market is characterized by excessive competition, with over 4,500 production companies and approximately 2,400 traditional Chinese medicine enterprises, leading to a potential consolidation as weaker companies may exit the market [5][6]. - The policy could facilitate a shift from a fragmented market to a more robust and high-quality development phase, aligning better with consumer needs [6].
年销10亿元的“儿童止咳药”,新增风险提示意味着什么?
Xin Jing Bao· 2026-01-22 04:30
Core Viewpoint - The recent announcement by the National Medical Products Administration (NMPA) regarding the pediatric medication Montelukast has raised significant concerns about its safety, particularly regarding neuropsychiatric side effects, prompting a reevaluation of its use in children [2][5][16]. Group 1: Drug Safety Concerns - Montelukast, a commonly used pediatric medication with annual sales exceeding 1 billion yuan, has been linked to neuropsychiatric adverse reactions, including depression and suicidal tendencies, as well as stuttering [2][16]. - The FDA had previously issued a black box warning in 2020, indicating serious mental health risks associated with Montelukast, which had not been adequately addressed in China until now [3][17]. - The recent NMPA announcement has led to widespread discussions among parents and healthcare professionals about the safety of this long-used pediatric drug [3][5]. Group 2: Clinical Usage and Misuse - Montelukast is often prescribed for common respiratory symptoms in children, leading to its perception as a "common medication" for cough and nasal congestion, despite not being a first-line treatment for these conditions [10][12]. - Studies indicate that a significant percentage of prescriptions for Montelukast are inappropriate, with 96.26% of cases showing unsuitable indications or dosages [13]. - The drug's misuse is attributed to various factors, including parental reluctance to use inhaled corticosteroids and the convenience of oral medication [14][25]. Group 3: Regulatory and Clinical Response - The delay in updating Montelukast's safety information in China reflects broader issues in drug safety management, including slow responses to international warnings and the need for better communication of risks to healthcare providers [24][25]. - Experts emphasize the importance of balancing treatment benefits against potential side effects, advocating for more timely risk communication to clinicians and patients [5][20]. - The ongoing debate surrounding Montelukast highlights the necessity for continuous monitoring and evaluation of drug safety, as well as the need for regulatory bodies to act swiftly on emerging safety signals [28].
“春雷行动2026”专项执法行动启动
Xin Lang Cai Jing· 2026-01-11 22:26
Core Viewpoint - The Sichuan Provincial Market Supervision Administration has launched a special enforcement action named "Spring Thunder Action 2026" focusing on six key areas: food safety, drug safety, quality of life, special equipment safety, intellectual property, and market order [1] Group 1: Food Safety - The enforcement will closely monitor seasonal foods and key products for New Year's Eve dinners, as well as focus on tourist attractions and schools [1] - There will be strict investigations into illegal activities such as "two exceedances and one non-compliance" and adulteration [1] Group 2: Drug Safety - The focus will be on medical beauty institutions and online pharmaceutical sales companies [1] - There will be a severe crackdown on the sale of counterfeit and inferior drugs, as well as illegal purchasing channels [1] Group 3: Quality of Life - The action will target quality hazards in winter hot-selling products and important industrial goods [1] - There will be a strong crackdown on illegal modifications of electric bicycles [1] Group 4: Special Equipment Safety - A "zero tolerance" approach will be adopted to address inspection and testing irregularities and false maintenance issues [1] Group 5: Intellectual Property - The enforcement will focus on key categories such as alcoholic beverages and agricultural products, with strict actions against infringement, counterfeiting, and malicious registration [1] Group 6: Market Order - The action will address issues such as false advertising, price fraud, and "big data killing familiarity" [1]
云南省药品监督管理局公布五起典型案例
Core Viewpoint - The Yunnan Provincial Drug Administration has published five typical cases to strengthen the supervision of drug safety and combat illegal activities related to drugs, cosmetics, and medical devices, ensuring public health and safety. Group 1: Case Summaries - Case 1: A pharmacy in Changning purchased drugs from unqualified individuals, leading to the confiscation of illegal drugs and a fine totaling 250,000.00 yuan for the illegal purchase of drugs valued at 33,252.00 yuan [2][3] - Case 2: A gang led by Jiang Mouyan was involved in the production and sale of counterfeit drugs, resulting in the seizure of over 1.1 million suspected counterfeit drugs and a total case value exceeding 50 million yuan. The main offenders received prison sentences ranging from 1 year to 11 years and fines totaling 233,000 yuan [4][5] - Case 3: A traditional Chinese medicine clinic in Gejiu used expired drugs, leading to a fine of 20,000.00 yuan and the confiscation of expired drugs valued at 942.85 yuan [6][7][8] - Case 4: A hospital in Wenshan prepared traditional Chinese medicine without the necessary license, resulting in the confiscation of 381 bags of unlicensed medicine and a fine based on illegal gains of 28,600.00 yuan [9][10] - Case 5: A hair product store in Shangri-La sold unregistered cosmetics and failed to maintain proper purchase records, leading to a total fine of 5,105.00 yuan and the confiscation of 13 bottles of cosmetics [11][12]
贯彻落实党的二十届四中全会精神权威访谈丨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
Xin Hua Wang· 2025-12-11 00:43
Core Viewpoint - The article emphasizes the importance of strict and efficient regulation in promoting 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 NMPA has implemented comprehensive reforms in drug regulation, ensuring overall stability in drug safety and advancing the construction of a strong pharmaceutical nation [2]. - Continuous strengthening of supervision has led to a significant increase in the overall pass rate of drug safety inspections from 97.8% during the 13th Five-Year Plan to 99.4% [2]. - A total of 220 innovative drugs and 282 innovative medical devices have been approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3]. Group 2: Future Measures for Drug Safety Regulation - The NMPA plans to enhance the drug safety responsibility system and transition from a "passive defense" to a "proactive prevention" approach [5]. - A focus on dynamic safety regulation across the entire supply chain will be implemented, addressing new challenges posed by product and technological innovations [6]. - Strict enforcement against illegal activities will be prioritized, with improved mechanisms for cross-regional and cross-level case handling [6]. Group 3: Support for Innovative Drug and Medical Device Development - The NMPA will support enterprises in enhancing their research and development capabilities for innovative drugs and medical devices, emphasizing the importance of effective market and proactive government roles [7]. - Policies will be optimized to accelerate the approval process for innovative products, particularly those that are globally novel or critical for domestic substitution [8]. - The NMPA aims to improve the regulatory framework for traditional Chinese medicine, ensuring quality management and modernization of production processes [8]. Group 4: Enhancing Public Benefit from Regulatory Reforms - The NMPA will prioritize enhancing public access to innovative treatments and ensuring that regulatory reforms benefit the general population [9]. - Efforts will be made to streamline the approval process for urgently needed drugs, including those for rare diseases and pediatric use [9]. - Collaboration with health and insurance departments will be strengthened to ensure comprehensive drug safety and accessibility [10].