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转自：辽宁药监局  编辑：wangxinglai2004 近日，辽宁药监局发布了药品检查通知，艾尔健康眼药（辽宁）有限公司、原研药港生物制药（沈阳）股份有限公司接受了飞行检查，共计发现7类问题。 01 艾尔健康眼药（辽宁）有限公司 企业类型：药品生产企业   检查时间：2024年4月13日-2024年4月16日 所在地市：沈阳市 检查依据：药品管理法及其条例、药品生产监督管理办法、我局2024年度监督检查计划、《关于开展药品委托生产监督管理专项检查工作的通知》 检查事项：药品生产检查   检查方式：飞行检查  检查内容：药品生产、持有人委托生产专项等 存在问题： 在验证管理方面个别验证管理不规范； 个别人员培训不到位； 持有人与受托方签订的生产质量协议部分条款不明确。  02 原研药港生物制药（沈阳）股份有限公司 企业类型：药品生产企业   检查时间：2024年4月13日-2024年4月16日 所在地市：沈阳市 检查依据：药品管理法及其条例、药品生产监督管理办法、我局2024年度监督检查计划、《关于开展药品委托生产监督管理专项检查工作的通知》 检查事项：药品生产检查   检查方式：飞行检查  检查内容：药品生产、持有人委托生产专项等 存在问题： 在验证管理方面，个别验证管理不规范； 制水岗位个别操作不规范； 个别检验用辅助设备的校准管理不规范； 个别检验记录不规范。

The academic health system's president and CEO is recognized by Becker's Hospital Review for his leadership in health care innovation in Tampa Bay and beyond. TAMPA, Fla., June 17, 2024 /PRNewswire/ -- John Couris, president and CEO of Tampa General Hospital (TGH), has been recognized as a top health care leader in the U.S. by Becker's Hospital Review in its list of "Great Leaders in Healthcare" for 2024, which highlights leaders across the industry who are using innovative digital technology, novel care delivery approaches and creative care solutions to shape the future of health care. Couris is one of 84 leaders recognized across hospitals, health systems and other companies in the health care industry nationally. He is one of just four Florida health care leaders recognized and is the only leader representing the Tampa Bay region. Continue Reading Tampa General Hospital President and CEO John Couris has been recognized as a top health care leader in the U.S. by Becker’s Hospital Review in its list of “Great Leaders in Healthcare” for 2024, which highlights leaders across the industry who are using innovative digital technology, novel care delivery approaches and creative care solutions to shape the future of health care. This recognition marks Couris' third consecutive year that he is included on this list, which underscores his ability to lead and inspire Tampa General's dynamic team, including its world-class physicians, and his dedication to transforming health care delivery and increasing accessibility to innovative medical solutions across the Tampa Bay region, statewide and beyond. Couris is recognized as a national expert in health care, organizational leadership, workplace culture transformation and management, operational excellence, team member and stakeholder engagement and strategic collaboration. He has led Tampa General's transformation to a true academic health system, including the enterprise's growth from 17 facilities to now six hospitals and more than 150 care locations statewide, employing approximately 14,000 team members and providers. "I am tremendously proud of the transformation journey our collective Tampa General team has been on together over the last several years, which has positioned us well to serve not only as our region's only academic health system but as one of the nation's most innovative academic health systems," Couris said. "Our Board of Directors and team members are unwavering in their commitment to elevating patient care, pursuing innovative approaches and delivering exceptional outcomes. I am honored to work alongside a team with a common passion for pushing accepted boundaries and redefining world-class patient care." Since joining Tampa General as president and CEO in 2017, Couris has championed innovation. With Couris at the helm, Tampa General established an artificial intelligence and predictive analytics care coordination center designed to improve the safety, quality and affordability of health care. Couris is forging strategic partnerships with leading artificial intelligence, predictive analytics and technology providers to streamline clinical workflows, automate administrative workflows and provide additional decision-making support to providers and front-line caregivers. Earlier this month, Tampa General announced the system will deploy Palantir's Artificial Intelligence Platform (AIP) to deliver a Care Coordination Operating System. Today, Couris is leading the execution of Tampa General's largest master facility plan in the hospital's history, as well as driving the ongoing development of the Tampa Medical and Research District in downtown Tampa, which is already attracting renowned clinicians and researchers, improving access to experts, innovative medical research, education and technology for patients and students and, upon completion, is estimated to generate a total economic impact of $8.3 billion annually. The district skyline will soon include the TGH Behavioral Health Hospital, expected to open in 2025, which will offer highly specialized and personalized care for many behavioral and mental health conditions and became certified as the first of only four behavioral health teaching hospitals in Florida statute, in partnership with the USF Health Morsani College of Medicine. The academic health system also recently broke ground on the Taneja Surgical, Neuroscience & Transplant Tower, a 13-story medical pavilion in the heart of Tampa Bay, where patients will have access to best-in-class providers, the latest research therapies and state-of-the-art technologies. To advance world-class care in Tampa Bay and across the industry, Couris collaborates closely with elected officials at the local, state and federal levels. In May, he was appointed to Florida's first-ever Health Care Innovation Council by Senate President Kathleen Passidomo, a statewide volunteer organization established this year to advance innovation in health care as part of the Senate's priority Live Healthy initiative. Couris played an instrumental role in the development and passage of the Live Healthy legislation and advocated both at the state and federal levels to advance and expand access to hospital at home programs, such as the academic health system's TGH at Home program. Couris' focus on reimagining care coordination, forging strategic partnerships and driving innovation has resulted in significant improvements in the quality of care and patient outcomes at Tampa General, as well as the overall patient care experience, as shown by externally measured quality scores, safety ratings and Press Ganey survey results. His leadership philosophy is built around the principles of a proprietary model he developed and has implemented across the system, AKTiVE, which focuses on leading with authenticity, kindness, transparency, vulnerability and empathy. Couris strongly believes in putting team members first by recognizing the whole person – including their lived experiences inside and outside of the workplace – and investing in the personal and professional development of each team member, regardless of their role or tenure. These efforts to build and foster a culture of belonging continue to drive high performance and better patient outcomes and have resulted in a consistent year-over-year increase in physician and team member engagement scores. In addition to his strong leadership within the health care industry, Couris prioritizes actively serving the Tampa Bay community as a member of several boards and professional associations. Collectively, these efforts have earned Tampa General continued national recognition as one of Newsweek's "World's Best Hospitals," Newsweek's "World's Best Smart Hospitals," Forbes' "America's Best-in-State Employers," Newsweek's "Best Cancer Hospitals," and Fortune/Merative "100 Top Hospitals," among others. Becker's Hospital Review is a leading source of hospital business news and analysis for the health care industry. Couris and the rest of this year's "Great Leaders in Healthcare" honorees are profiled by Becker's Hospital Review here. ABOUT TAMPA GENERAL HOSPITAL Tampa General Hospital, a 981-bed, not-for-profit, academic health system, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News and World Report's 2023-24 Best Hospitals, with six specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – in the top 100 nationally in the 2023 America's Best Employers for Women and top 25 in Florida in the 2023 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit of approximately $240.3 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida . It also is home to the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes TGH North which is comprised of three hospitals and several outpatient locations in Citrus and Hernando counties, 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Outpatient Center, TGH Virtual Health, and 21 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to . Media Contact: Beth Hardy, APR Assistant Manager Publications & Physician Communications (727) 510-6363 (cell) [email protected] SOURCE Tampa General Hospital

每周药品注册获批数据，分门别类呈现，一目了然。(6.11-6.16） 新药上市申请药品名称企业注册分类受理号泽美洛韦玛佐瑞韦单抗注射液兴盟生物医药(苏州)有限公司1CXSS2200053国;CXSS2200053泽美洛韦玛佐瑞韦单抗注射液兴盟生物医药(苏州)有限公司1CXSS2200052国;CXSS2200052特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300053特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300052 新药临床申请药品名称企业注册分类受理号SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400317SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400316SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400315YK-051南京优科制药有限公司1CXHL2400296HSK42360片西藏海思科制药有限公司1CXHL2400306HSK42360片西藏海思科制药有限公司1CXHL2400305ASP3082注射液安斯泰来(中国)投资有限公司1CXHL2400308HY-021068片合肥医工医药股份有限公司1CXHL2400330KY386注射用浓溶液深圳开悦生命科技有限公司1CXHL2400338ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400321ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400320布洛芬注射液山东新华制药股份有限公司3CYHL2400067布洛芬注射液山东新华制药股份有限公司3CYHL2400066注射用IAP0971盛禾(中国)生物制药有限公司1CXSL2400100注射用BGB-R046广州百济神州生物制药有限公司1CXSL2400208HY1272注射液恒翼生物医药(上海)股份有限公司1CXSL2400211 仿制药申请药品名称企业注册分类受理号帕拉米韦氯化钠注射液江苏吴中医药集团有限公司苏州制药厂3CYHS2202034国;CYHS2202034缩宫素注射液上海葆隆生物科技有限公司3CYHS2000879国;CYHS2000879尼莫地平口服溶液广东金城金素制药有限公司3CYHS2100073国;CYHS2100073艾司奥美拉唑镁肠溶胶囊浙江永太药业有限公司3CYHS2200943国;CYHS2200943艾司奥美拉唑镁肠溶胶囊浙江永太药业有限公司3CYHS2200941国;CYHS2200941氨甲环酸注射液烟台鲁银药业有限公司3CYHS2201532国;CYHS2201532氨甲环酸注射液烟台鲁银药业有限公司3CYHS2201531国;CYHS2201531己酮可可碱注射液湖南科伦制药有限公司3CYHS2201638国;CYHS2201638西洛他唑片成都倍特药业股份有限公司3CYHS2201667国;CYHS2201667己酮可可碱注射液苏州朗科生物技术股份有限公司3CYHS2201692国;CYHS2201692倍他米松磷酸钠注射液重庆华邦制药有限公司3CYHS2201703国;CYHS2201703帕拉米韦注射液福安药业集团烟台只楚药业有限公司3CYHS2201738国;CYHS2201738盐酸多巴胺注射液通合生物医药(山东)有限公司3CYHS2201817国;CYHS2201817重酒石酸间羟胺注射液海南天盛保和生物科技有限公司3CYHS2202126国;CYHS2202126盐酸多巴酚丁胺注射液北京布霖生物科技有限公司3CYHS2300097盐酸多巴酚丁胺注射液华夏生生药业(北京)有限公司3CYHS2300094盐酸肾上腺素注射液海南倍特药业有限公司3CYHS2300192法莫替丁注射液重庆药谷制药有限公司3CYHS2300234盐酸倍他司汀片森淼(山东)药业有限公司3CYHS2300349盐酸右美托咪定注射液山西远扬医药科技有限公司3CYHS2300625复方磷酸盐颗粒嘉实(湖南)医药科技有限公司3CYHS2301310中性腹膜透析液(碳酸氢盐-G4.25)芜湖道润药业有限责任公司3CYHS2201647国;CYHS2201647中性腹膜透析液(碳酸氢盐-G2.5)芜湖道润药业有限责任公司3CYHS2201646国;CYHS2201646中性腹膜透析液(碳酸氢盐-G1.5)芜湖道润药业有限责任公司3CYHS2201644国;CYHS2201644中性低钙腹膜透析液(碳酸氢盐-G2.5)芜湖道润药业有限责任公司3CYHS2201642国;CYHS2201642盐酸利多卡因局部溶液成都慧德医药科技有限公司3CYHS2301936恩曲他滨丙酚替诺福韦片石家庄龙泽制药股份有限公司4CYHS2202116国;CYHS2202116氨氯地平阿托伐他汀钙片昆山龙灯瑞迪制药有限公司4CYHS2300338低钙腹膜透析液(乳酸盐-G4.25)上海长征富民金山制药有限公司4CYHS2300883低钙腹膜透析液(乳酸盐-G2.5)上海长征富民金山制药有限公司4CYHS2300882低钙腹膜透析液(乳酸盐-G1.5)上海长征富民金山制药有限公司4CYHS2300881沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101755国;CYHS2101755沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101754国;CYHS2101754沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101753国;CYHS2101753塞来昔布胶囊北京世桥生物制药有限公司4CYHS2200718国;CYHS2200718钆特醇注射液正大天晴药业集团股份有限公司4CYHS2200913国;CYHS2200913富马酸伏诺拉生片重庆华森制药股份有限公司4CYHS2200908国;CYHS2200908富马酸伏诺拉生片重庆华森制药股份有限公司4CYHS2200907国;CYHS2200907富马酸丙酚替诺福韦片南京海辰药业股份有限公司4CYHS2201237国;CYHS2201237地诺孕素片西安太极药业有限公司4CYHS2201323国;CYHS2201323溴芬酸钠滴眼液中山万汉制药有限公司4CYHS2201340国;CYHS2201340盐酸雷洛昔芬片重庆圣华曦药业股份有限公司4CYHS2201439国;CYHS2201439溴芬酸钠滴眼液中山万汉制药有限公司4CYHS2201616国;CYHS2201616左卡尼汀注射液华中药业股份有限公司4CYHS2201640国;CYHS2201640左卡尼汀注射液华中药业股份有限公司4CYHS2201639国;CYHS2201639缬沙坦氨氯地平片(I)长春海悦药业股份有限公司4CYHS2201717国;CYHS2201717注射用哌拉西林钠他唑巴坦钠江苏睿实生物科技有限公司4CYHS2201726国;CYHS2201726注射用哌拉西林钠他唑巴坦钠江苏睿实生物科技有限公司4CYHS2201725国;CYHS2201725盐酸乌拉地尔注射液吉林省辉南长龙生化药业股份有限公司4CYHS2201822国;CYHS2201822盐酸乌拉地尔注射液吉林省辉南长龙生化药业股份有限公司4CYHS2201821国;CYHS2201821奥拉帕利片杭州中美华东制药有限公司4CYHS2201855国;CYHS2201855奥拉帕利片杭州中美华东制药有限公司4CYHS2201854国;CYHS2201854溴莫尼定噻吗洛尔滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201864国;CYHS2201864丙酸氟替卡松雾化吸入用混悬液上海新黄河制药有限公司4CYHS2201885国;CYHS2201885枸橼酸西地那非口腔崩解片南京长澳制药有限公司4CYHS2201886国;CYHS2201886盐酸莫西沙星滴眼液海南斯达制药有限公司4CYHS2201904国;CYHS2201904伏立康唑片武汉启瑞药业有限公司4CYHS2201916国;CYHS2201916伏立康唑片武汉启瑞药业有限公司4CYHS2201915国;CYHS2201915富马酸丙酚替诺福韦片江苏科本药业有限公司4CYHS2201936国;CYHS2201936氢溴酸伏硫西汀片山东京卫制药有限公司4CYHS2202031国;CYHS2202031盐酸乌拉地尔注射液湖南科伦制药有限公司4CYHS2202064国;CYHS2202064盐酸乌拉地尔注射液湖南科伦制药有限公司4CYHS2202065国;CYHS2202065棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202111国;CYHS2202111棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202110国;CYHS2202110棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202109国;CYHS2202109棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202108国;CYHS2202108棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202107国;CYHS2202107舒更葡糖钠注射液南京正大天晴制药有限公司4CYHS2202129国;CYHS2202129舒更葡糖钠注射液南京正大天晴制药有限公司4CYHS2202128国;CYHS2202128卡培他滨片江苏诚康药业有限公司4CYHS2202139国;CYHS2202139钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202160国;CYHS2202160钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202159国;CYHS2202159钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202158国;CYHS2202158注射用盐酸表柔比星浙江华海药业股份有限公司4CYHS2202149国;CYHS2202149马昔腾坦片上海旭东海普药业有限公司4CYHS2202176国;CYHS2202176碳酸镧咀嚼片江西施美药业股份有限公司4CYHS2300102左氧氟沙星滴眼液苏州弘森药业股份有限公司4CYHS2300098磷酸特地唑胺片桂林南药股份有限公司4CYHS2300180盐酸奥洛他定滴眼液国药集团三益药业(芜湖)有限公司4CYHS2300255他达拉非片新乡市常乐制药有限责任公司4CYHS2300274间苯三酚注射液湖南科伦制药有限公司4CYHS2300283富马酸比索洛尔片浙江京新药业股份有限公司4CYHS2300376富马酸比索洛尔片浙江京新药业股份有限公司4CYHS2300375沙美特罗替卡松吸入粉雾剂健康元药业集团股份有限公司4CYHS2300405注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300450注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300449注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300448吸入用硫酸沙丁胺醇溶液浙江百代医药科技有限公司4CYHS2300508恩格列净片宁波大红鹰药业股份有限公司4CYHS2300601注射用头孢他啶阿维巴坦钠山东百诺医药股份有限公司4CYHS2300703阿卡波糖片成都恒瑞制药有限公司4CYHS2300702多巴丝肼片北京福元医药股份有限公司4CYHS2300742格列齐特缓释片浙江京新药业股份有限公司4CYHS2301097阿伐替尼片基石药业(苏州)有限公司4CYHS2301700奥美沙坦酯氨氯地平片郑州韩都药业集团有限公司4CYHS2301875氧九龙气体河北有限公司4CYHS2302089氧辉县市广福贸易有限公司4CYHS2302128氧香格里拉藏龙纯净氧气体有限公司4CYHS2302226盐酸特比萘芬乳膏齐鲁制药(海南)有限公司4CYHS2301721头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401101头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401100西甲硅油乳剂成都诺和晟鸿生物制药有限公司4CYHS2401170富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101007国;JYHS2101007富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101006国;JYHS2101006富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101005国;JYHS2101005 进口申请药品名称企业注册分类受理号高血糖素鼻用粉雾剂Eli Lilly and Company5.1JXHS2200063国;JXHS2200063依伏卡塞片Kyowa Kirin Co., Ltd.5.1JXHS2200069国;JXHS2200069依伏卡塞片Kyowa Kirin Co., Ltd.5.1JXHS2200068国;JXHS2200068地舒单抗注射液Amgen Europe B.V.3.1JXSS2300031Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400070Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400069Golcadomide胶囊Celgene Corporation1JXHL2400084Golcadomide胶囊Celgene Corporation1JXHL2400083Golcadomide胶囊Celgene Corporation1JXHL2400082PF-07264660注射液Pfizer Inc.1JXSL2400066PF-07275315注射液Pfizer Inc.1JXSL2400065CID-103注射液CASI Pharmaceuticals, Inc.1JXSL2400067 中药相关申请 无 注：橙色字体部分结论为不批准或收到通知件；