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药品质量安全监管
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新疆乌苏市市场监管局全力筑牢中药饮片质量安全防线
Zhong Guo Shi Pin Wang· 2025-07-10 02:58
Core Viewpoint - The Xinjiang Uygur Autonomous Region's Urumqi City Market Supervision Administration is enhancing the quality safety inspection of traditional Chinese medicine (TCM) pieces to ensure public safety in medication use [1][2]. Group 1: Regulatory Actions - The administration is focusing on key areas such as the legality of procurement channels for TCM pieces, adherence to inspection and documentation protocols, and ensuring traceability of TCM sources [1]. - Inspections include checking the storage conditions of TCM pieces, ensuring that temperature and humidity control devices are functioning properly to prevent spoilage [1]. - The clarity and compliance of labeling on TCM pieces are being scrutinized, including details like product name, specifications, origin, manufacturer, and production date [1]. Group 2: Findings and Future Plans - The inspection revealed that most businesses are adhering to their responsibilities, with generally compliant quality management of TCM pieces, although some issues such as incomplete procurement records and lack of clear pricing were noted [2]. - The administration plans to strengthen regulatory efforts by establishing a long-term supervision mechanism and conducting regular follow-up inspections to consolidate the results of special checks [2]. - There will be a strict crackdown on illegal activities related to TCM pieces to ensure the safety and effectiveness of medication for the local population [2].
国家药监局:对药品医疗器械质量安全内部举报人举报实施奖励丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-06-05 23:57
Group 1 - The National Medical Products Administration (NMPA) has announced a reward system for internal whistleblowers reporting major violations in drug and medical device quality safety, reflecting a commitment to strengthen regulatory oversight in the industry [1] - The introduction of an internal whistleblower incentive mechanism is expected to enhance compliance management among pharmaceutical and medical device manufacturers, promoting long-term healthy development in the industry [1] Group 2 - Sanofi's new drug application for a recombinant anti-IL-1β humanized monoclonal antibody injection for acute gouty arthritis has been accepted by the NMPA, following successful Phase III clinical trials [2] - With over 80 million gout patients in China and a rapid annual growth rate of 9.7%, the market potential for this treatment is significant, and targeting IL-1β is a valuable therapeutic option [2] - The differentiated binding site of the new drug compared to existing products may provide a competitive edge, although its clinical efficacy needs to translate into market competitiveness [2] Group 3 - Zai Lab has signed an exclusive marketing service agreement with Merck's Swiss subsidiary for a recombinant human thyroid-stimulating hormone injection, with a potential maximum authorization fee of RMB 250 million [3] - The agreement includes an initial payment of RMB 50 million and a subsequent payment of RMB 200 million upon approval of the first indication for the product, which is currently in the registration phase [3] - The introduction of this product is expected to fill a gap in the market for post-operative diagnosis of thyroid cancer, leveraging the synergy with Merck's other recommended thyroid medications [3] Group 4 - Maipu Medical has announced plans to acquire 100% equity of Yijie Medical through a combination of share issuance and cash payment, aiming to expand its product offerings into the interventional field [4] - The acquisition is expected to enhance the company's competitive advantage in the research and development of interventional biomaterials and improve marketing efficiency in neurology departments [4] - The company's stock will resume trading on June 6 following the announcement of this acquisition [4]