转自：山东省药品监督管理局网站 按照《山东省药品经营企业长期停业和恢复经营监督管理规定》（鲁药监规〔2023〕8号），国药控股浩源（平度）医药有限公司等3家药品经营企业在《药 品经营许可证》有效期内申请停业。停业期间，企业承诺不开展药品经营活动。企业在《药品经营许可证》有效期内恢复药品经营，需向药监部门提交书面 报告，并经检查符合要求后方可恢复经营活动。 现予以公告。 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 ...

证券日报网讯1月30日，陇神戎发（300534）发布公告称，公司控股子公司甘肃药业集团三元医药有限 公司因仓库地址变更，近日获甘肃省药监局换发新《药品经营许可证》，仓库迁至兰州市榆中县定远镇 国防路10号，有效期至2028年9月18日，经营范围含中药饮片、中成药、化学药及生物制品批发。 ...

三是规范药品经营和使用。完善药品网络销售管理制度，压实药品网络交易第三方平台提供者责任。加 强医疗机构药事管理，保障使用环节药品质量。明确医疗机构配制制剂审批流程，规定医疗机构制剂调 剂使用条件和程序，支持配制儿童用医疗机构制剂，满足儿童患者用药需求。 四是严格药品安全监管。明确药品安全监督检查措施。细化药品质量抽查检验流程，规定当事人对检验 结果有异议的，可以申请复验。针对违法行为设定了严格的法律责任。 二是加强药品生产管理。严格药品委托生产管理，压实委托生产时药品上市许可持有人的责任，明确可 以委托分段生产药品的情形。明确中药饮片、中药配方颗粒生产、销售的管理要求。 新华社北京1月27日电 国务院总理李强日前签署国务院令，公布修订后的《中华人民共和国药品管理法 实施条例》（以下简称《条例》），自2026年5月15日起施行。《条例》共9章89条，修订后的主要内容 如下。 一是完善药品研制和注册制度。支持以临床价值为导向的药品研制和创新，鼓励研究和创制新药，支持 新药临床推广和使用。明确药物非临床安全性评价研究机构资格认定程序，细化药物临床试验管理要 求。设立药品上市注册加快程序，明确药品再注册程序，规定处方 ...

1月6日至7日，全国药品监督管理工作会议在北京召开。会议强调，2026年要围绕实现"十五五"良好开 局，抓住关键，纲举目张，做好以下重点工作。一是全力保障药品高水平安全。完善药品安全责任体 系，提升临床试验监管水平，加强高风险品种生产监管，聚焦集采中选等重点品种加大检查和抽检力 度，开展药品经营环节"清源"巩固提升行动，强化网络销售监管，切实守牢药品安全底线。二是积极支 持医药产业发展提质增效。全面深化药品监管改革，落实对重点品种实行"提前介入、一企一策、全程 指导、研审联动"的要求，支持医药研发创新，推动中药守正创新发展，支持医疗器械高水平自立自 强，促进美丽经济发展壮大。三是不断提升药品监管法治化水平。持续健全药品监管法律法规体系，完 善药品标准体系，提高行政执法权威性和公信力，加大面向企业和基层的普法宣传力度，进一步夯实药 品监管的法治基础。四是扎实推进药品监管现代化建设。高质量编制"十五五"药品规划，扎实推进全国 药品监管一体化，加强监管人才队伍和技术支撑能力建设，深化监管信息化建设和药品监管科学研究应 用，深度参与全球药品安全治理，推动中国药品监管国际影响力再上新台阶。 （文章来源：第一财经） ...

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]

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]

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]

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]

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 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]