药品经营
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山东省药品监督管理局关于药品经营企业长期停业的公告(2026年第2期)
Xin Lang Cai Jing· 2026-02-11 03:19
Core Viewpoint - The announcement by the Shandong Provincial Drug Administration highlights the long-term suspension of operations for three pharmaceutical companies, including Guoyao Holdings Haoyuan (Pingdu) Pharmaceutical Co., Ltd, in accordance with local regulations [2] Group 1: Regulatory Compliance - The companies have applied for suspension of operations while their Drug Business Licenses are still valid [2] - During the suspension period, the companies are committed to not engaging in any pharmaceutical business activities [2] - To resume operations, companies must submit a written report to the drug administration and pass an inspection to ensure compliance with requirements [2]
陇神戎发:公司控股子公司甘肃药业集团三元医药有限公司近日获甘肃省药监局换发新《药品经营许可证》
Zheng Quan Ri Bao Wang· 2026-01-30 10:43
Group 1 - The core point of the article is that Longshen Rongfa (300534) announced the relocation of its subsidiary, Gansu Pharmaceutical Group Sanyuan Pharmaceutical Co., Ltd., which has received a new Drug Business License from the Gansu Provincial Drug Administration due to the change of warehouse address [1] - The new warehouse is located at No. 10, National Defense Road, Dingyuan Town, Yuzhong County, Lanzhou City, and the license is valid until September 18, 2028 [1] - The business scope of the subsidiary includes wholesale of traditional Chinese medicine pieces, Chinese patent medicines, chemical drugs, and biological products [1]
公布修订后的《中华人民共和国药品管理法实施条例》
Xin Lang Cai Jing· 2026-01-27 22:09
Core Viewpoint - The revised Implementation Regulations of the Drug Administration Law of the People's Republic of China will take effect on May 15, 2026, aiming to enhance drug research, production, and safety management in the pharmaceutical industry [1][2]. Group 1: Drug Research and Registration - The regulations support drug development and innovation based on clinical value, encouraging the research and creation of new drugs [1] - A fast-track registration process for drug market entry is established, along with clear re-registration procedures and mechanisms for converting prescription drugs to over-the-counter status [1] - Special market exclusivity is granted for pediatric medications and treatments for rare diseases, along with data protection for drugs containing novel chemical components [1] Group 2: Drug Production Management - The regulations enforce strict management of commissioned drug production, clarifying the responsibilities of drug market license holders during the commissioning process [1] - Specific management requirements for the production and sale of traditional Chinese medicine pieces and formula granules are outlined [1] Group 3: Drug Operation and Usage - The regulations improve the management system for online drug sales, holding third-party platforms accountable for drug transactions [1] - Enhanced pharmaceutical management in medical institutions is mandated to ensure drug quality during usage [1] - Approval processes for the preparation of formulations in medical institutions are specified, supporting the preparation of pediatric formulations to meet the needs of child patients [1] Group 4: Drug Safety Supervision - The regulations clarify drug safety supervision and inspection measures, detailing the process for quality sampling and testing [2] - Strict legal responsibilities are established for violations, ensuring accountability within the pharmaceutical sector [2]
国家药监局:开展药品经营环节“清源”巩固提升行动 持续健全药品监管法律法规体系
Di Yi Cai Jing· 2026-01-07 10:38
Core Viewpoint - The national drug supervision management conference emphasized key tasks for achieving a good start in the 14th Five-Year Plan by 2026, focusing on drug safety, industry development, legal regulation, and modernization of drug supervision [1] Group 1: Drug Safety - The conference highlighted the need to ensure high-level drug safety by improving the drug safety responsibility system and enhancing the supervision of clinical trials [1] - There will be increased inspections and sampling for key varieties, particularly those selected in centralized procurement [1] - The conference called for strengthening the regulation of online sales and maintaining a strict bottom line for drug safety [1] Group 2: Industry Development - Support for the pharmaceutical industry will be enhanced through comprehensive reforms in drug regulation, with a focus on early intervention and tailored guidance for key products [1] - The conference aims to promote innovation in drug research and development, as well as the development of traditional Chinese medicine and high-level self-reliance in medical devices [1] - There is an emphasis on fostering the growth of the beautiful economy within the pharmaceutical sector [1] Group 3: Legal Regulation - Continuous improvement of the legal and regulatory framework for drug supervision is a priority, including enhancing the authority and credibility of administrative law enforcement [1] - The conference plans to increase legal awareness among enterprises and grassroots organizations to solidify the legal foundation of drug supervision [1] Group 4: Modernization of Drug Supervision - The conference aims to develop a high-quality "14th Five-Year" drug planning and promote the integration of national drug supervision [1] - There will be a focus on building a capable regulatory workforce and enhancing technological support for drug supervision [1] - The conference also emphasizes the importance of participating in global drug safety governance to elevate China's international influence in drug regulation [1]
额敏县市场监督管理局:药品“清源”行动,双机制筑牢安全防线
Zhong Guo Shi Pin Wang· 2025-12-29 10:57
Core Viewpoint - The E'min County Market Supervision Administration has launched a "Clearing Source" action to regulate drug business practices and enhance drug quality supervision, ensuring public safety in medication use [1][2] Group 1: Action Mechanisms - A "screening-correction-acceptance" mechanism has been established to ensure safety through a closed-loop management system, focusing on issues such as the sale of counterfeit drugs and illegal procurement [1] - The action has resulted in inspections of 77 drug business enterprises, issuance of 26 corrective notices, and investigation of 13 illegal cases [1] Group 2: Collaborative Efforts - A "clue sharing-joint law enforcement-criminal connection" mechanism has been created to improve the efficiency of case handling, involving collaboration with health, medical insurance, and public security departments [1] - Eight inspection actions have been conducted, with five instances of case processing information shared with relevant departments and five case clues transferred [1] Group 3: Future Plans - The E'min County Market Supervision Administration plans to continue strengthening daily supervision and special rectification efforts, maintaining a high-pressure regulatory stance against drug-related violations [2] - There will be an increased emphasis on public education to encourage community involvement in drug safety supervision, fostering a supportive atmosphere for drug safety governance [2]
广东省药品监督管理局关于药品经营监督检查评定结果的通告(2025年第109号)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-12-29 08:57
Core Insights - The Guangdong Provincial Drug Administration conducted inspections on 41 pharmaceutical companies, all of which met the regulatory requirements [1][2] Group 1: Inspection Results - All 41 pharmaceutical companies inspected received a "compliant" rating, indicating they met the necessary regulatory standards [1] - The companies are located across various cities in Guangdong Province, including Guangzhou, Shenzhen, and Dongguan [1] Group 2: Company Listings - Notable companies that passed the inspection include: - Guangdong New Pharma Co., Ltd. in Chaozhou - China National Pharmaceutical Group Guangzhou Co., Ltd. in Guangzhou - Guangdong Waning Chain Commercial Co., Ltd. in Guangzhou - Shenzhen Yiyuan Health Smart Pharmacy Chain Co., Ltd. in Shenzhen [1][2]
兵团持续筑牢药品安全防线
Xin Lang Cai Jing· 2025-12-19 18:23
Core Viewpoint - The Xinjiang Production and Construction Corps (XPCC) has launched a "Clean Source Action" to address prominent issues in the pharmaceutical distribution sector, focusing on comprehensive inspections and strict regulatory measures to enhance drug safety and compliance [1] Group 1: Regulatory Actions - The "Clean Source Action" involves a thorough inspection of pharmaceutical business practices, with a focus on risk assessment and enforcement of regulations [1] - Regulatory authorities have inspected 2,453 pharmaceutical enterprises at both the XPCC and division levels, mandating timely rectification of identified violations [1] Group 2: Focus Areas of Inspection - Inspections target key issues such as unauthorized business operations, procurement from illegal sources, tampering with computer system data, and failure to upload or verify drug traceability codes [1] - Multiple regulatory measures have been implemented to address industry irregularities, aiming to purify the pharmaceutical market environment and strengthen drug safety defenses [1]
山东11.5万家药品经营企业、医疗机构入驻追溯平台
Da Zhong Ri Bao· 2025-12-09 01:02
Core Insights - The "Qingyuan Action" has been launched in Shandong to address prominent issues in the pharmaceutical distribution sector, focusing on enhancing regulatory measures and ensuring public safety in medication use [1] Group 1: Regulatory Actions - The action targets five core pain points in the pharmaceutical distribution sector, including illegal drug sales, non-compliance in prescription drug sales, and online sales violations [1] - Strict measures are being implemented to combat counterfeit drugs and the illegal circulation of drugs through improper channels, thereby reducing quality and safety risks [1] - The initiative emphasizes the responsibility of enterprises, promoting legal awareness and compliance through education and warnings [1] Group 2: Monitoring and Compliance - The provincial drug monitoring system has adopted a comprehensive approach with full coverage, online monitoring, and coordinated cross-departmental regulation [1] - Over 3,000 regulatory personnel have been equipped with a dedicated app for drug traceability, enhancing the precision of both online and offline monitoring [1] - Continuous monitoring of online pharmaceutical sales is being conducted to promptly address any suspected illegal activities [1] Group 3: Traceability System - The province has established a comprehensive drug traceability system, with 115,000 pharmaceutical enterprises and medical institutions registered on the traceability platform, leading the nation in both the number and rate of registered entities [2]
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
Zhong Guo Zhi Liang Xin Wen Wang· 2025-11-11 05:01
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]