转自：云南省药品监督管理局网站 查办结果：蒋某艳等人生产、销售假药的行为违反了《中华人民共和国药品管理法》第九十八条第一款规定，触犯了《中华人民共和国刑法》第一百四十一 条第一款规定，构成生产、销售假药罪。2025年4月，经楚雄州武定县人民法院审理，对5名主犯判决如下：（一）以生产、销售假药罪判处蒋某艳有期徒刑 11年6个月、罚金233万元、附带民事公益诉讼惩罚性赔偿金33.6万元，判处蒋某德有期徒刑10年4个月、罚金135万元、附带民事公益诉讼惩罚性赔偿金18.6 万，判处黄某仙有期徒刑3年缓期5年执行、罚金11万元，判处蒋某刚有期徒刑1年、罚金10万元；（二）以销售假药罪判处范某海有期徒刑4年6个月、罚金 53万元、附带民事公益诉讼惩罚性赔偿金7.77万。 三、个旧市某中医诊所使用劣药案 案情概述：2025年5月14日，个旧市市场监督管理局（以下简称个旧局）根据举报线索，对个旧市某中医诊所（以下简称当事人）药品使用情况进行现场检 查。现场检查发现药品"龟甲胶"19片（批号：2103011，包装规格：14片/板×3板/盒，有效期至：2024-02-29），个旧局现场对上述药品采取了扣押的行政强 制措施，并于 ...

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].

Core Viewpoint - The article emphasizes the importance of strict regulation in promoting the development of innovative drugs and medical devices, highlighting the balance between ensuring drug safety and fostering industry innovation [1] Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, China's 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] - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2] Group 2: Promoting Industry Innovation - A total of 220 innovative drugs and 282 innovative medical devices were approved since the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines, indicates a growing vitality in pharmaceutical innovation [3] Group 3: Future Measures for Drug Safety - The regulatory focus will shift from "passive defense" to "active prevention," enhancing the drug safety responsibility system and improving risk management capabilities [4] - A comprehensive dynamic safety supervision system will be established, covering the entire lifecycle of drugs, from research and development to production and use [5] Group 4: Supporting Innovation in Pharmaceuticals - The regulatory body will support enterprises in enhancing their innovative drug and medical device research and development, emphasizing policy guidance and resource allocation for original products [6] - Efforts will be made to accelerate the market entry of innovative drugs and medical devices by optimizing registration processes and reducing costs [7] Group 5: Enhancing Public Welfare - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that regulatory reforms benefit all citizens and meet their health needs [8] - Measures will be taken to expedite the approval of urgently needed drugs, including those for rare diseases and children, while maintaining high standards [9] Group 6: Interdepartmental Collaboration - Strengthening coordination with health and insurance departments will be crucial for improving clinical trial oversight and drug traceability systems [10] - Public awareness campaigns will be conducted to enhance understanding of drug regulations and promote a supportive environment for innovative drug and device development [11]

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 Points - The Supreme People's Procuratorate reported that in the first three quarters of this year, a total of 7,316 individuals were prosecuted for food safety crimes, highlighting a significant enforcement effort against food and drug safety violations [1][2][3] Group 1: Prosecution Data - In the first nine months of 2025, 1,025 cases involving food safety crimes led to the arrest of 1,693 individuals, with 3,762 cases resulting in prosecutions of 7,316 individuals [1] - For drug safety crimes, 279 cases resulted in the arrest of 443 individuals, with 1,354 cases leading to prosecutions of 2,668 individuals [1] Group 2: Characteristics of Cases - The prosecution efforts exhibit three distinct characteristics: comprehensive chain attacks, integrated prosecutorial functions, and adherence to a balanced criminal policy [2][3] - The comprehensive chain attacks involve targeting all links in the crime chain, from production to retail, as demonstrated in a case involving the sale of counterfeit health products [2] - Integrated prosecutorial functions include collaboration between criminal prosecution and public interest litigation to address consumer rights violations and social welfare damage [2] Group 3: Ongoing Efforts and Future Directions - The Supreme People's Procuratorate plans to continue intensifying efforts against food and drug safety crimes, focusing on dismantling criminal networks and improving the connection between law enforcement and regulatory mechanisms [3] - The establishment of a comprehensive supervision model for food safety is being pursued, which includes recommendations for administrative enforcement against violators [2][3] Group 4: Case Examples - A notable case involved the production and sale of counterfeit health products, where over 120,000 bottles were sold, generating illegal profits exceeding 8 million yuan [5][6] - Another case highlighted the illegal sale of meat from sick cattle, with over 200 heads involved and illegal profits amounting to over 510,000 yuan [11][12] - A case involving the production of toxic and harmful foods included the sale of products containing unapproved substances, with significant health risks identified [18][19] Group 5: Legal and Regulatory Implications - The prosecution of food safety crimes emphasizes the need for strict adherence to legal standards and the importance of consumer protection [24][25] - The establishment of a legal supervision model aims to enhance accountability within the food industry and ensure compliance with safety regulations [28][29]

Core Points - The World Health Organization (WHO) issued a global alert regarding three cough syrups produced in India, warning of serious health risks associated with these products [1] - The syrups in question are "Coldrif" from Sresan Pharmaceuticals, "Respifresh TR" from Rednex Pharmaceuticals, and "ReLife" from Shape Pharma, which may lead to severe illness or death [1] - Testing revealed that the content of diethylene glycol (DEG) in these syrups exceeded the permissible limit by nearly 500 times, posing a significant health threat [1] Summary by Sections Health Risks - The WHO has raised concerns about the health risks posed by the contaminated cough syrups, which have been linked to the deaths of at least 20 children in India [1][2] - Symptoms observed in affected children included fever, vomiting, and difficulty urinating, leading to fatalities [1] Regulatory Actions - Indian authorities have arrested the head of Sresan Pharmaceuticals, and the company's production license will be permanently revoked [2] - Several local governments have banned the use of the implicated cough syrups, with new regulations prohibiting the use of any cough or cold syrups for children under two years old [2] Export and Distribution Concerns - The Indian drug regulatory agency reported that the contaminated syrups have not been exported, and no evidence of illegal exports has been found [1] - The WHO expressed concern that such problematic products could enter other countries through informal channels [1]

Core Points - The World Health Organization (WHO) has requested clarification from the Indian government regarding the export of contaminated cough syrups, which may lead to a global medical product alert [1][2] - At least 17 children under the age of 5 have died in India after consuming cough syrups containing toxic substances, with 11 more children in critical condition [1] - The Indian drug regulatory authority has confirmed serious violations at multiple pharmaceutical factories, although specific companies involved have not been disclosed [1] - The contaminated syrups contained dangerously high levels of diethylene glycol and propylene glycol, with diethylene glycol levels approaching 500 times the permissible limit [1] - The WHO will decide on issuing a global medical alert after receiving official confirmation from Indian authorities, which could trigger global recalls and stricter monitoring of Indian drug exports [2] - The contaminated cough syrups are linked to the deaths of over 140 children in countries such as Gambia, Uzbekistan, and Cameroon during 2022-2023 [2]

Core Points - Indian drug regulatory authorities conducted inspections revealing serious violations in several pharmaceutical companies, particularly regarding the testing of drug raw materials for each batch [1][2] - At least 17 children under the age of five have died after consuming cough syrups containing toxic substances, with the levels of diethylene glycol reaching nearly 500 times the permissible limit [2] Group 1: Regulatory Actions - The inspections were prompted by previous findings of "substandard drugs" from the companies involved [1] - The Gujarat state government has ordered an immediate halt to all production and sales activities of the two inspected companies [2] - The company "Sresan Pharmaceuticals" has had its offices and factories shut down, and police are investigating the firm for "murder" charges [2] Group 2: Export Concerns - The cough syrups in question were reportedly sold only within India, but the World Health Organization is seeking clarification on whether these products were exported to other countries [2] - Indian pharmaceuticals are widely exported to developing countries, and there are concerns about the association of toxic cough syrups with the deaths of over 140 children in countries like Gambia, Uzbekistan, and Cameroon [2]

Group 1: Safety Development in Hubei - Hubei province has achieved significant progress in safety development during the "14th Five-Year Plan" period, with a focus on risk prevention, safety assurance, and stability maintenance [1] - The province has been recognized for its safety production performance, ranking 5th nationally in 2023 and 4th in 2024, with a continuous decline in major safety incidents over the past 51 months [1] - Natural disaster response has improved, with a 57.3% reduction in affected population, a 69.9% decrease in deaths and disappearances, and a 68.4% drop in direct economic losses compared to the "13th Five-Year Plan" period [1] Group 2: Emergency Management System - Hubei has established a comprehensive emergency management system characterized by unified command, rapid response, and collaborative efforts across various levels [2] - The province has made significant investments in disaster relief resources, ensuring that supplies can meet the basic needs of 500,000 disaster-affected individuals for three days [2] - Over the past five years, Hubei has addressed over 2.59 million safety hazards, focusing on major disaster factors such as fire and explosion risks [2] Group 3: Natural Disaster Prevention - Hubei has enhanced its natural disaster prevention capabilities by building a unified early warning platform and conducting comprehensive risk assessments for 21 types of disasters [3] - Key infrastructure improvements include the reinforcement of 120 large and medium-sized reservoirs and the construction of 4,409 kilometers of forest fire emergency roads [3] - The province has provided assistance to 9.644 million disaster-affected individuals and repaired over 16,000 damaged homes in the past five years [3] Group 4: Pharmaceutical Industry Growth - The number of pharmaceutical companies in Hubei has increased by 42% during the "14th Five-Year Plan" period, reflecting a robust growth in the sector [4] - Hubei's drug safety measures have led to the investigation of 24,700 cases of violations, with a 99% pass rate in drug quality inspections [4] - Public satisfaction regarding drug safety has reached 89.4%, indicating improved public confidence in medication safety [4] Group 5: Support for Pharmaceutical Development - Hubei has approved 13 Class I innovative drugs, ranking 6th nationally and 1st in Central China, with a total of 445 pharmaceutical production enterprises established [5] - The province has also seen a 58% increase in Class II and III medical device manufacturers, contributing to a thriving market for safe and effective medical products [5] - The number of retail pharmacies has grown by 37%, enhancing access to quality pharmaceutical products for the public [5]

Core Points - The meeting organized by the Liu Lin County Market Supervision Administration focused on advancing the "Clearing Source" action in the pharmaceutical sector and educating pharmaceutical enterprises on warnings [1][3] - Liu Lin County has made progress in drug safety this year, but there are still shortcomings that need to be addressed, such as the inadequate implementation of corporate responsibilities and a weak awareness of the "first responsible person" [1][3] - The director emphasized the importance of drug safety for public health and social stability, urging for stronger measures and practical approaches to ensure the safety and effectiveness of medications for the public [3] Summary by Sections Meeting Overview - The meeting was chaired by Gao Xuemei, a level-three chief staff member, and included specific work arrangements [1] - Niu Fuying, a section chief, reported on warning cases during the meeting [1] Current Status and Challenges - Liu Lin County has achieved certain results in drug safety, but there are still issues such as insufficient corporate responsibility and a need for enhanced grassroots regulatory capabilities [1][3] Future Actions - The director called for a resolute commitment to drug safety, emphasizing the need for effective measures and a practical approach to strengthen drug safety efforts in Liu Lin County [3]