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甘肃省药品监督管理局公布5起药品领域违法案件典型案例
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]
额敏县市场监督管理局: 规范药品经营使用,守护群众用药安全
Zhong Guo Shi Pin Wang· 2025-10-23 09:03
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]
柳林召开药品经营企业警示教育会
Sou Hu Cai Jing· 2025-09-25 01:31
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]
海南省药品监督管理局关于依法注销海南天诺药业有限公司等3家企业 《药品经营许可证》的公告(2025年第5号)
Core Points - The Hainan Provincial Drug Administration has legally revoked the drug business licenses of three companies: Hainan Tiannuo Pharmaceutical Co., Ltd., Hainan Yangpu Junhe Pharmaceutical Co., Ltd., and China National Pharmaceutical Group Professional Pharmacy Chain (Hainan) Co., Ltd. [2][4] - The revocation requires these companies to immediately cease drug business activities and invites public supervision [2][4]. Company Summaries - **Hainan Tiannuo Pharmaceutical Co., Ltd.** - Location: 2nd Floor, No. 22B1 and 22B2, Shimao Yayu, Shimao East Road, Haikou City, Hainan Province - Warehouse Address: No. 10, Jianzheng Road, National Pharmaceutical Holdings Hainan Co., Ltd. [3] - Business Scope: Traditional Chinese medicine, chemical drugs (including raw materials), biological products (excluding refrigerated and frozen drugs) [3]. - License Number: AA898000025 [3]. - **Hainan Yangpu Junhe Pharmaceutical Co., Ltd.** - Location: H206, H Building, Hainan Yangpu Economic Development Zone [3]. - Warehouse Address: No. 10, Jianzheng Road, National Pharmaceutical Holdings Hainan Co., Ltd. [3]. - Business Scope: Chinese herbal pieces, traditional Chinese medicine, chemical drugs (including raw materials), biological products, protein anabolic agents, and peptide hormones (including refrigerated and frozen drugs) [3]. - License Number: AA898000235 [3]. - **China National Pharmaceutical Group Professional Pharmacy Chain (Hainan) Co., Ltd.** - Location: No. 10, Jianzheng Road, Longhua District, Haikou City, Hainan Province [3]. - Warehouse Address: No. 10, Jianzheng Road, National Pharmaceutical Holdings Hainan Co., Ltd. [3]. - Business Scope: Chinese herbal pieces, traditional Chinese medicine, chemical drugs, biological products (excluding cell therapy biological products), blood products, protein anabolic agents, and peptide hormones (limited to insulin, including refrigerated and frozen drugs) [3]. - License Number: BA898000053 [3].
新疆乌苏市市场监管局把好国庆节前“安全关”
Zhong Guo Shi Pin Wang· 2025-09-23 03:53
Core Viewpoint - The Xinjiang Uygur Autonomous Region's Urumqi City Market Supervision Administration is actively conducting safety inspections in preparation for the upcoming National Day holiday to ensure public safety and prevent accidents [1][3]. Group 1: Food Safety - Focus on inspecting holiday-related food items such as grains, oils, vegetables, and fruits, with special checks on the sourcing, product certification, shelf life, and inventory records of food sold in markets and supermarkets [3]. - Inspections will also target hot pot restaurants and large-scale dining establishments, with a commitment to follow up on any identified issues to ensure compliance with food safety responsibilities [3]. Group 2: Drug Safety - Random checks will be conducted on standalone pharmacies, medical institutions, chain stores, and cosmetic businesses to ensure compliance with safety regulations, with a focus on rectifying any discovered issues [3]. Group 3: Special Equipment Safety - Comprehensive safety inspections will be carried out on special equipment such as pressure vessels, boilers, elevators, and forklifts, ensuring that safety management protocols are effectively implemented [3]. - Immediate corrective actions will be mandated for any identified problems, and safety regulations will be communicated to equipment operators to enhance overall safety awareness [3]. Group 4: Future Actions - The administration plans to intensify safety supervision during the holiday period, streamline complaint channels, and strictly enforce laws to protect the rights of consumers and operators, ensuring a joyful holiday for the public [4].
新田召开药品经营环节“清源”行动隐患排查暨培训会
Sou Hu Cai Jing· 2025-09-16 02:27
Core Points - The New Tian County Market Supervision Bureau organized a training meeting for the "Qingyuan" action in the pharmaceutical business sector to enhance risk management and compliance [2] - The meeting emphasized the importance of companies fulfilling their primary responsibilities and conducting thorough risk assessments [2] Group 1: Action Plan and Requirements - The "Qingyuan" action work plan was announced, detailing the requirements for deepening the initiative in the pharmaceutical sector [2] - Pharmaceutical companies are urged to learn from past cases and actively engage in self-inspection and correction of risks [2] Group 2: Key Focus Areas - Companies must ensure that drug procurement and acceptance processes are conducted through legitimate channels with complete qualifications [2] - Accurate and timely collection of traceability information for drug storage and handling is essential [2] - Strict adherence to prescription requirements for the sale of prescription drugs, including verification by licensed pharmacists, is mandated [2] Group 3: Training and Awareness - The training improved the legal awareness, responsibility consciousness, and quality awareness of quality managers and key personnel [2] - Companies are required to establish detailed problem lists and rectification accounts, ensuring compliance within specified deadlines [2] - The meeting highlighted the need for companies to adhere to the "three rights": legitimate procurement channels, corrected pharmaceutical practices, and ethical sales practices [2]
山西省天镇县市场监管局开展药品经营环节“清源”行动教育警示会
Core Points - The meeting organized by the Shanxi Province Tianzhen County Market Supervision Bureau aimed to regulate the pharmaceutical market and combat illegal activities in drug circulation [1] - The meeting conveyed the requirements for the "Qingyuan" action and discussed typical cases of drug management violations [1] - Emphasis was placed on the legal responsibilities and severe consequences of non-compliance with drug management laws [1] Summary by Sections Regulatory Actions - The Tianzhen County Market Supervision Bureau will enhance enforcement checks under the "Qingyuan" action to maintain a high-pressure stance against illegal activities in drug management [2] - The meeting highlighted the need for pharmaceutical companies to conduct self-inspections and address potential risks in their operations [1] Compliance and Responsibilities - Pharmaceutical enterprises are urged to learn from case studies and fulfill their primary responsibilities, focusing on key areas such as procurement, storage, and prescription sales [1] - Companies must establish detailed problem lists and rectification accounts to ensure compliance within specified deadlines [1]
镇原县“五步法”筑牢食药安全防线 企业自查自改见实效
Zhong Guo Shi Pin Wang· 2025-09-08 02:28
Group 1 - The core viewpoint of the article emphasizes the proactive measures taken by the Zhenyuan County Market Supervision Bureau to enhance food and drug safety through a structured self-inspection and rectification process for enterprises [1][2][3] Group 2 - The implementation of a five-step work method, including selecting models, itemized inspections, establishing ledgers, comprehensive reviews, and supervision acceptance, has led to significant progress in self-regulation among food and drug production and operation units [1] - Enterprises are encouraged to conduct thorough inspections across all processes, including raw material procurement, production, storage, transportation, sales management, labeling, and personnel health, ensuring no hidden risks remain [1][2] - Each enterprise is required to maintain a detailed self-inspection and rectification ledger, documenting issues found, corrective measures, responsible personnel, and completion deadlines, with a zero-tolerance approach to identified risks [2] - A strict review process is in place to ensure accountability, with the county divided into four areas for comprehensive verification of self-inspections, rewarding thorough self-checks while penalizing inadequate ones [2] - A special inspection team has been established to conduct random checks on the effectiveness of self-inspections and rectifications, ensuring that the work is genuinely implemented and not merely formalistic [2] - As of now, 102 drug operating enterprises have completed risk inspections, rectifying 17 issues, while 395 food production and operation enterprises have conducted self-inspections, identifying and rectifying 68 issues [2] - The Zhenyuan County Market Supervision Bureau plans to continue strengthening daily supervision and establishing long-term mechanisms to maintain and improve food and drug safety [3]
国药一致:公司下半年没有大规模关店的计划
Core Viewpoint - The company announced that it does not plan to close a large number of stores in the second half of the year, despite the impact of online business on offline operations [1] Group 1: Company Strategy - The company is actively embracing online business while also adjusting its product categories to enhance competitiveness in attracting customer traffic [1] - The company acknowledges that the pharmaceutical business is unique, and online sales will not completely replace offline sales [1]
【浙江省】2025年药品经营企业常规(飞行)检查公告 (第一期)
Core Viewpoint - The article provides an overview of the first batch of GSP (Good Supply Practice) inspections for pharmaceutical companies in Zhejiang Province for the year 2025, highlighting compliance status and the types of products handled by various companies [2][3]. Group 1: Compliance Status - Several companies, including 澎尚医药有限公司 and 浙江湖州联康医药有限公司, have been reported as compliant with GSP requirements [2]. - Companies such as 温州长生堂药房连锁有限公司 and 浙江昊辰医药有限公司 also meet the necessary compliance standards [2][3]. - A few companies, including 阿童木云端医药(杭州)有限公司 and 浙江朗昇医药有限公司, were noted as not meeting the compliance requirements [3]. Group 2: Product Range - The inspected companies handle a variety of pharmaceutical products, including 中成药 (traditional Chinese medicine), 化学药 (chemical drugs), and 生物制品 (biological products) [2][3]. - Specific companies, like 浙江同益医药有限公司, deal with cold chain products, including those requiring refrigeration or freezing [2]. - The product offerings also include prescription and non-prescription drugs, with some companies focusing on 中药饮片 (Chinese herbal pieces) and 抗生素制剂 (antibiotic preparations) [3].