人民财讯1月7日电，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。 ...

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 "14th Five-Year Plan" period marks a critical phase for the pharmaceutical regulatory sector in Shaanxi Province, emphasizing the importance of political leadership, regulatory rigor, and innovation to ensure drug safety and promote the development of the pharmaceutical industry [1] Group 1: Leadership and Governance - The Shaanxi Provincial Drug Administration has integrated the leadership of the Communist Party into all aspects of drug regulation, aiming to build a trustworthy regulatory team [2] - The agency has implemented a standardized construction of party branches and created 35 party brand initiatives to enhance regulatory effectiveness [3] Group 2: Regulatory Framework and Risk Management - The agency has established a comprehensive drug safety protection system, focusing on risk prevention and control, and has developed a risk assessment mechanism to proactively manage potential issues [6][7] - A total of 4,839 inspections of drug production and 442,303 inspections of drug distribution and use have been conducted, leading to the identification and rectification of numerous violations [8] Group 3: Technological Innovation and Digital Transformation - The Shaanxi Provincial Drug Administration is advancing a smart regulatory system, including the establishment of a drug safety regulatory platform and a drug regulatory big data center, which has processed over 21.7 million applications [10][11] - The drug safety risk management system has identified 23,614 safety risk signals, providing a robust technical foundation for high-quality regulatory oversight [12] Group 4: Industry Support and Development - The agency has optimized the review and approval processes for innovative drugs, significantly reducing approval times and supporting the development of 77 innovative drug specifications [14][15] - Policies have been implemented to encourage the quality and efficacy consistency of generic drugs, with a total of 52.7 million yuan in rewards distributed to relevant enterprises [16] Group 5: Cultural and Educational Initiatives - The agency has focused on enhancing the cultural atmosphere of integrity within the pharmaceutical sector, addressing 288 issues and implementing 397 corrective measures over five years [5] - Educational programs and training sessions have been conducted to improve the capabilities of regulatory personnel, including 230 participants in emergency management training [7]

Group 1: Market Regulation Achievements - Since the beginning of the 14th Five-Year Plan, the national market regulatory authorities have improved the supervision system for enterprise-related fees, continuously reducing operational costs for businesses. The number of new enterprises increased by 19.99 million, and individual businesses increased by 33.94 million [1][2] - The introduction of the "Fair Competition Review Regulations" has established rigid institutional constraints against issues such as "malicious competition" in investment promotion and administrative monopolies. A total of 4,218 policies that hindered the flow of factors were abolished, and 239 administrative monopoly cases were investigated [1][2] Group 2: Consumer Protection and Efficiency - During the 14th Five-Year Plan, market regulatory authorities handled 89.03 million complaints, recovering economic losses of 21.71 billion yuan for consumers. Consumer associations processed 5.75 million complaints, recovering 5.78 billion yuan [2] - The time required to open a restaurant has been reduced from 37 days to 15 days, and the number of documents required for business information changes has been streamlined from 23 to 6 [2] Group 3: Platform Economy Regulation - The platform economy is undergoing a critical transformation, with the integration of digital technology across industries leading to new growth points but also risks such as algorithm abuse and disorderly competition. Regulatory authorities are balancing innovation encouragement with development regulation [4][5] - Regulatory actions have led to the removal of 4.54 million illegal product listings and the suspension of services for 58,000 online stores. Major cases in the live-streaming e-commerce sector have been addressed [5] Group 4: Pharmaceutical Industry Developments - China's pharmaceutical industry ranks second globally, with 204 innovative drugs and 265 innovative medical devices approved since the beginning of the 14th Five-Year Plan. The number of innovative drugs in development accounts for about 30% of the global total [7][8] - The National Medical Products Administration has implemented dynamic supervision covering the entire drug lifecycle, focusing on key areas such as online sales and clinical trial management [7][8]