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国家药监局新政:药品医械举报有奖,合规之路再升级
21世纪经济报道记者 唐唯珂 广州报道 医械监管持续走深走实。 药品、医疗器械等是重要的健康产品,产品质量问题影响国计民生保障,消费者一般难以在前期辨别优 劣。肃清产业链、保质让利、深化安全监管势在必行。 去年年底,国务院常务会议部署深化药品医疗器械监管改革,促进医药产业高质量发展有关举措。会议 指出,要深化药品医疗器械监管全过程改革,更好满足群众对高质量药品医疗器械的需求。要加大对药 品医疗器械研发创新支持,积极推广使用创新药和医疗器械。要提高审评审批质效,加快临床急需药品 医疗器械审批上市。 南开大学法学院院长、南开大学医药卫生法研究中心主任宋华琳此前表示,关于《医疗器械监督监管条 例》解读看法时曾指出,现行监管行政法规在监管方式、监管程序等方面规定不够细致,法律责任的设 定较为粗放,严谨性不足,其作用已经不符合当下医疗器械行业的发展实际,未能完全按照高风险健康 产品监管的全过程,或者按照风险监管的逻辑去设计相应监管结构和框架。 此外也有医械行业人士对21世纪经济报道记者表示,此次奖励内部人员实名举报,是深入贯彻落实监管 改革的重要举措,完善了动态监管机制。联动内部员工、相关知情人共同参与监督,能够让监督 ...
澳洲证监会酝酿改革:私募信贷监管、IPO市场活力双线推进
Sou Hu Cai Jing· 2025-06-03 01:12
今年市场最热的问题之一是: 澳洲监管机构将如何应对私人市场资产(尤其是私募信贷)的迅猛增长,并改革日渐低迷的首次公开募股(IPO) 市场? 本周,澳洲证券与投资委员会(ASIC)或许会对其思路做出一定澄清。对于放贷人、银行家和投资者来说,任何新信息都值得关注。 Simone Constant, an ASIC commissioner, is scheduled to speak at an investor symposium mid week. Louise Kennerley ASIC委员西蒙妮·康斯坦特(Simone Constant)将于本周中出席一场投资者研讨会并发表讲话。 这些议题与澳洲长期的经济和金融系统健康密切相关,也影响到国家证券交易所的地位。近年来,澳交所(ASX)退市公司的数量远远超过新上 市企业。 因此,ASIC主席乔·隆戈(Joe Longo)必须精准拿捏改革蓝图。 对于私人市场,ASIC面临艰难平衡:一方面要加强透明度与披露义务、在经济下行时保护系统稳定;另一方面又不能让业界背负过多合规负担。 事实上,ASIC已着手针对私募信贷(private credit)开展审查行动,向市场 ...
我省全方位支持医药产业创新发展
Liao Ning Ri Bao· 2025-05-29 00:46
施政聚焦降本增效,增强竞争优势。制定出台《辽宁省普通化妆品完整版安全评估资料审核标准 (2025年版)》,实现以全国最低价格为我省企业开展检验检测,检验检测费用降低60%以上。政策出 台后仅一个月企业提交完整版安评资料42个,同比增长950%。 同时,坚持协同联动,全方位构建产业发展生态。省药监局联合本溪市、沈抚示范区、沈阳市浑南 区签约共建医疗器械创新服务站,在政策咨询、申报指导、业务培训、信息收集等方面,为企业提 供"家门口"的服务,形成"一站式"解决方案,实现综合服务窗口前移,通过赋能营商环境软实力,提升 当地招商引资吸引力,促进医疗器械项目落地和产业集聚,助力医疗器械产业高质量发展。 我省支持药械创新发展,优化审评审批,加速创新成果转化。制定出台《关于药品上市后生产场地 变更优先审评审批的公告》《医疗器械产品注册与生产许可核查工作程序》等文件,压缩审评审批时 限,降低检查频次。政策实施以来,已对260余家企业的检查予以优化,减少涉企检查3600余个工作 日;7家企业的9个第二类医疗器械产品按照优先注册程序批准上市,2家外省企业的2个第二类医疗器械 产品在我省注册,审评审批时限大幅压缩。 惠企政策更加顺 ...
Wells Fargo(WFC) - 2025 FY - Earnings Call Transcript
2025-05-28 13:00
Financial Data and Key Metrics Changes - The company is focused on increasing return on tangible common equity towards 15% while managing expenses and investments carefully [48][59] - The stress capital buffer increased by 90 basis points, raising concerns about the company's risk profile despite no perceived increase in risk [11] Business Line Data and Key Metrics Changes - The retail deposit franchise is being revitalized with a focus on primary checking account growth and improved customer relationships [19][23] - The company is seeing early impacts in checking account growth, debit spend, and active mobile users as it shifts focus towards customer-centric strategies [24] Market Data and Key Metrics Changes - There is a noted lack of loan demand in the banking system, which is affecting overall growth despite a stable loan-to-deposit ratio [60][67] - The competitive environment is intensifying as banks seek to grow their loan portfolios, leading to more aggressive pricing strategies [68] Company Strategy and Development Direction - The company is transitioning from an inward focus on risk management to a more outward focus on growth and customer service [13][18] - Investments are being made in technology and infrastructure to enhance operational efficiency and customer experience, including significant spending on cyber security and core platform upgrades [32][36] Management's Comments on Operating Environment and Future Outlook - Management acknowledges a period of macroeconomic uncertainty but remains optimistic about consumer and corporate spending resilience [3][4] - The company is preparing for potential regulatory changes that could lift the asset cap, allowing for more growth opportunities [40][44] Other Important Information - The company has successfully addressed most of the regulatory orders it faced, with only two remaining, which is expected to enhance its operational flexibility [40][42] - The focus on AI and technology is seen as transformative, with efforts to improve efficiency and customer service through automation and data analysis [37][38] Q&A Session Summary Question: What are the avenues for growth in the consumer deposit side? - The company is focused on rebuilding its retail system from the ground up, emphasizing primary checking account growth and improving customer satisfaction scores [20][22] Question: What are the biggest opportunities for growth among various business lines? - Management believes all business lines should grow faster than current rates, with particular caution in home lending and auto businesses [26][27] Question: How does the company plan to balance investments and returns? - The company aims to reduce expenses while increasing investments in high-return areas, ensuring that growth does not compromise profitability [49][50] Question: What is the outlook for loan growth given the current environment? - Loan growth is constrained by demand rather than the asset cap, with management hopeful for increased demand as economic conditions improve [61][63]
辽宁:加快生物医药和医疗器械产业提质升级
Zhong Guo Xin Wen Wang· 2025-05-28 09:21
辽宁创新服务,全链条支持药械创新发展。支持研发创新,推动产业提质升级。持续开展创新药械 精准帮扶行动,将3个新药和57个医疗器械产品纳入帮扶清单,深入企业开展现场帮扶指导134家次,清 单中的1个产品通过国家药监局创新医疗器械审查,2个产品纳入辽宁省药监局优先注册通道获批上市。 据介绍,辽宁优化审评审批,加速创新成果转化,制定出台《关于药品上市后生产场地变更优先审 评审批的公告》《医疗器械产品注册与生产许可核查工作程序》《辽宁省第二类医疗器械优先注册程序 (试行)》《关于鼓励已上市医疗器械来辽宁注册生产的公告》等文件,压缩审评审批时限,降低检查频 次。 中新网沈阳5月28日电 (记者 韩宏)记者28日从辽宁省政府新闻办召开的发布会获悉,辽宁加快生物 医药和医疗器械产业提质升级助力辽宁医药产业高质量发展。 下一步,辽宁省药监局将全过程深化药品监管改革,全方位筑牢药品安全底线,全链条支持医药产 业高质量发展,让更多企业享受到辽宁省深化药品医疗器械监管改革释放的红利。 5月28日,辽宁省政府新闻办召开的发布会现场。韩宏 摄 政策实施以来,已对260余家企业的检查予以优化,减少涉企检查3600余个工作日;7家企业的9 ...
白宫高级官员:行政令要求能源部和国防部合作在联邦土地上建设核能项目。要求对核能监管委员会进行“重大改革”,其中包括审查人员配置情况。
news flash· 2025-05-23 18:18
白宫高级官员:行政令要求能源部和国防部合作在联邦土地上建设核能项目。要求对核能监管委员会进 行"重大改革",其中包括审查人员配置情况。 ...
美国参议院推进具有里程碑意义的加密法案,民主党人出现分歧
news flash· 2025-05-20 02:01
金十数据5月20日讯,美国参议院周一投票推进具有里程碑意义的加密货币立法,16名民主党人在一项 关键的程序性动议上与大多数共和党人站在一起,这可能为参议院通过其首次加密监管改革奠定基础。 参议院以66票赞成、32票反对的投票结果继续推进该法案。此前,两党进行了一系列谈判,共和党同意 对法案进行一系列修改,以赢得足够多的民主党人的支持,从而达到通过该法案所需的60票门槛。 美国参议院推进具有里程碑意义的加密法案,民主党人出现分歧 ...
优化资源配置以促进希腊经济增长(英)2025
IMF· 2025-05-19 10:30
Improve Resource Allocation to Boost Growth in Greece Ritong Qu SIP/2025/58 IMF Selected Issues Papers are prepared by IMF staff as background documentation for periodic consultations with member countries. It is based on the information available at the time it was completed on March 11, 2025. This paper is also published separately as IMF Country Report No 25/49. 2025 MAY © 2025 International Monetary Fund SIP/2025/58 | JEL Classification Numbers: | D24, E22, F41, O16, O47 | | --- | --- | | Keywords: | Pr ...
欧洲央行将在年底前提出资本中性监管改革建议。(彭博)
news flash· 2025-05-16 08:28
欧洲央行将在年底前提出资本中性监管改革建议。(彭博) ...
市场消息:欧洲央行将在年底前提出资本中性监管改革方案。
news flash· 2025-05-16 08:26
市场消息:欧洲央行将在年底前提出资本中性监管改革方案。 ...