两品一械(药品
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青海省海西州市场监管局:守牢药品安全底线 护航民生健康福祉
Zhong Guo Zhi Liang Xin Wen Wang· 2026-01-12 03:34
Core Viewpoint - In 2025, the Haixi Prefecture Market Supervision Administration in Qinghai Province aims to enhance the safety of drugs, medical devices, and cosmetics through strict regulatory measures, risk prevention, and capacity building, achieving no regional or systemic safety incidents throughout the year [1] Group 1: Regulatory Enhancements - The administration focuses on improving regulatory efficiency by enhancing the professional skills of its workforce, conducting four specialized training sessions attended by over 150 participants, covering key areas such as inspection techniques and electronic traceability systems [2] - A risk prevention mechanism has been established, including a risk assessment and consultation system for drugs and medical devices, leading to the issuance of 10 risk warnings throughout the year, all of which were addressed [2] Group 2: Market Environment Purification - The administration has implemented targeted regulations and strict enforcement in key areas, conducting over 1,200 inspections of drug retail and medical device businesses, resulting in 34 legal cases with fines totaling 290,000 yuan and the confiscation of over 1,159 non-compliant medical devices [3] - In clinical settings, 280 medical institutions were inspected, leading to 45 rectifications, and a total of 422 adverse drug reaction reports, 216 medical device incident reports, and 39 cosmetic adverse reaction reports were collected, exceeding annual targets [3] Group 3: Public Awareness and Education - The administration has expanded public awareness campaigns, reaching over 20,000 individuals through community events and distributing over 40,000 informational materials [4] - Online platforms were utilized to disseminate over 60 pieces of information regarding laws, safety practices, and risk warnings, achieving over 15,000 reads [4] - Training sessions for over 120 enterprise personnel were conducted to enhance compliance awareness and responsibility for quality safety [4]
内蒙古统一药品监管行政裁量标准
Xin Lang Cai Jing· 2026-01-06 00:55
Group 1 - The core viewpoint of the news is the issuance of four administrative discretion benchmarks in Inner Mongolia aimed at standardizing regulatory practices for "two drugs and one device" [1][2] - The benchmarks include the Administrative Licensing Discretion Benchmark, which covers 26 main administrative licensing items and 66 sub-items related to drug production, medical institution preparation licenses, and cosmetic production licenses [1] - The Administrative Inspection Discretion Benchmark outlines 15 administrative inspection items, including daily inspections of drug production, with clear guidelines on purpose, scope, principles, and responsibilities [2] Group 2 - The Administrative Coercive Discretion Benchmark specifies 12 administrative coercive measures, detailing the implementation, extension, and termination conditions for each measure [2] - The Administrative Reward Discretion Benchmark provides specific criteria and operational standards for administrative rewards, including 10 key aspects such as basis for setting rewards and implementation levels [2]