三是强化药品监管能力建设，不断提升监管效能。充实高素质专业化人才队伍，创新监管方式，优化监 管体系，强化覆盖药品全生命周期的监管协同，推进监管科学研究，持续提升监管能力，提高监管实效 和服务水平。 四是加强宣传解读和培训指导，确保法规有效实施。围绕《条例》的制定背景、改革举措、监管要求、 法律责任等规定，针对不同层级监管部门、不同类型企业开展内容丰富、形式多样的宣传和培训工作， 深刻理解和准确把握《条例》新规定、新要求，为《条例》实施营造良好环境。 近日，国家药品监督管理局发布公告，公告指出，国务院常务会议审议通过《中华人民共和国药品管理 法实施条例（修订草案）》（以下简称《条例》）。为切实做好《条例》的贯彻落实，国家药监局将重 点抓好以下几项工作。 一是严格监督执法，全力保障药品高水平安全。严格落实药品安全责任，加强药品全生命周期质量监 管，强化重点领域监督检查，加大执法力度，严厉打击药品违法行为，守牢药品安全底线。 二是持续深化药品监管改革，助力药品研制创新。加大药品研制创新支持力度，持续提高药品审评审批 质效，加快更多满足人民群众需求的好药新药上市，不断增强医药产业的创新活力和市场竞争力。 （国家药品监 ...

四川省药品监督管理局工作人员正在进行放射性药品检测。 四川省凉山州布拖县牛角湾镇毫沟村的药田边，四川省药品监督管理局（以下简称省药监局）派驻人员带领 着专家，向当地农户细致讲解如何做好白及、穿心莲等药材的品质管控；成都医学城的工作站里，重点药械项目 专班成员正在提供覆盖从政策解读到注册申报的全周期"零距离"指导；药品质量检验检测行业技能竞赛的现场， 选手们一一辨识药材的性状、测定药物的成分……一幅幅生动画面，勾勒出"十四五"期间四川药品监管系统履职 尽责的行动图景。 5年来，省药监局始终坚持"讲政治、强监管、保安全、促发展、惠民生"的工作思路，高质量统筹发展与安 全、效率与公平、监管与服务，织就一张覆盖药品全生命周期的立体防护网。 构建"多元化"体系 实现药品高效能监管 随着药品监管改革的深入推进，药品监管体制机制显得尤为重要。如何建立科学高效权威的药品监管体 系？"十四五"时期，省药监局不断强化责任落实，夯实技术支撑，壮大监管队伍，凝聚社会力量，着力构建"政府 领导、部门协同、社会共治"的监管体系。 权责明晰使监管更有效。在全省药品监管"一盘棋"布局下，强化药品安全责任体系建设，持续完善"3层级+5 片区" ...

改革创新赋能产业，激活发展"新动能" 在持续深化审评审批改革方面，我省117个药械妆政务服务事项实现"一网通办""全程网办"，39个市县 级事项达成"全省一单"标准化管理。构建"国家级专家指导+省级精准服务+就近柔性服务"三级联动机 制，对创新药械实施"一企一策、全程指导"，助推芍药甘草颗粒、可降解耳鼻止血绵等创新产品上市， 填补多项省内空白。2024 年全省新增药品注册批准文号166 个，其中首仿药54个、同比增长170%；通 过仿制药一致性评价品规186个、同比增长132.5%。"十四五"以来，全省新增药械妆生产企业714 家、 增幅40.2%，新增药械临床试验机构43家、增幅205%，各类注册备案产品超9000个，产业发展能级显著 提升。 监管能力全面升级，夯实治理"硬支撑" 我省不断完善制度标准体系，累计制修订规章制度50余项、各类标准500余项，其中省级中药配方颗粒 标准408个。实施 "药监英才计划"，引进专业技术人员125名，聘任省级检查员1133 名，建成45家省内 外实训基地，带动近2万名监管人员和企业职工岗位练兵。16个市级药品检验检测机构全部达到国家C 级标准，"一体两翼"不良反应监测体 ...

齐鲁晚报.齐鲁壹点张唯 12月11日下午，在山东省政府新闻办举行的"'十四五'时期山东扎实推进市场监管现代化建设情况"新闻发布会上，围绕山东在"十四五"期间鼓励药械创 新、推动医药产业高质量发展方面，采取的举措与取得的成效等问题，山东省药品监督管理局党组书记、局长李涛作出回应。 李涛介绍，"十四五"期间，山东加大政策支持力度，省政府办公厅出台优化审评审批服务促进医药产业高质量发展若干措施，提出了对1类创新药临床试 验分期最高给予3000万元资金奖补等一系列政策措施。省药监局相继牵头出台促进医药产业高质量发展的"中药30条""医疗器械16条"等133条高含金量配 套措施，有力促进我省创新药械研发能力不断提升。"十四五"以来，全省1类创新药获批10个，为"十三五"时期的10倍；药物新产品获批1018个，年复合 增长率接近40%。 在深化药品监管改革方面，山东坚持以改革的手段破解发展中的难题，着力构建以省级为支点、联通上下、"扁平化"的服务体系。对上，主动融入京津冀 国家战略，积极争取将我省纳入国家药监局药品和医疗器械审评检查京津冀分中心服务范围，不仅让企业享受国家级的专业指导，更能强化区域间标准互 认、监管协同， ...

问题导向精准发力，办理实效惠企利民 面对代表委员关注的优化审评审批制度、打造国家级疫苗优质资源融合平台、加快建设世界一流生物医 药产业创新集群等问题，省药监局建立"主要领导领办、专班跟踪推进、成果闭环转化"机制，将46件建 议提案分解为94项具体任务，通过专题研判、列单挂账、"面对面"对接服务等方式逐项攻坚。截至10 月，帮助解决109家重点企业255条问题诉求，推动我省新获批上市药品324个、第三类医疗器械412个， 其中创新药15个、创新医疗（002173）器械10个，分别占全国总数的1/4、1/6，批准第二类医疗器械 1512个，数量均居全国前列。 "建议提案是民声的'风向标'，必须从'办文'转向'办事'，把代表的'金点子'转化为发展的'金钥匙'。"省 药监局党组书记、局长田丰在专题推进会上强调。为扎实推动惠企利民，省药监局牵头制定并提请省政 府办公厅出台《关于全面推进药品医疗器械监管深层次改革促进医药产业高质量发展的若干政策措 施》，针对性提出23项改革内容、83条具体措施，药品监管领域32项改革措施被纳入《中国(江苏)自由 贸易试验区生物医药全产业链开放创新发展方案》。 务实举措破解难题，监管服务双 ...

Core Insights - The pharmaceutical industry in China ranks second globally, with approximately 30% of innovative drugs under research worldwide [1][2] - The National Medical Products Administration (NMPA) is focused on ensuring drug safety, supporting high-quality development of the pharmaceutical industry, and meeting public medication needs [1][2] Group 1: Drug Safety Measures - China is enhancing dynamic regulation covering the entire lifecycle of drugs, establishing a risk consultation mechanism, and focusing on key areas such as online sales, contract manufacturing, and clinical trial management [1] - The country plans to conduct over 200,000 drug inspections, 20,000 medical device inspections, and 20,000 cosmetic inspections annually during the 14th Five-Year Plan [1] Group 2: Support for Pharmaceutical Development - Since the beginning of the 14th Five-Year Plan, 204 innovative drugs and 265 innovative medical devices have been approved, with 50 innovative drugs and 49 medical devices approved in the first seven months of this year [2] - The NMPA is implementing expedited review channels for breakthrough therapies and prioritizing the approval of key products through tailored guidance [1][2] Group 3: Meeting Public Medication Needs - The approval process for urgently needed foreign drugs has been optimized to allow faster access to the latest global drug developments for Chinese patients [2] - A total of 387 pediatric drugs and 147 rare disease drugs have been approved since the start of the 14th Five-Year Plan, addressing the medication needs of key populations [2]

Core Viewpoint - During the "14th Five-Year Plan" period, China is comprehensively deepening the reform of drug and medical device regulation to promote high-quality development in the pharmaceutical industry, with a national drug inspection pass rate stabilizing at over 99.4% [1] Group 1 - The National Medical Products Administration (NMPA) supports enterprises in conducting global clinical trials simultaneously, aiming to shorten the global market launch cycle for drugs [1] - The NMPA encourages foreign-invested enterprises to introduce original research drugs, biological products, and high-end medical equipment for domestic production [1] - The scope of export sales certification for drugs and medical devices is being expanded to provide strong support for the internationalization of Chinese pharmaceuticals [1] Group 2 - The establishment of three regional centers in Beijing-Tianjin-Hebei, Central China, and Southwest China is being accelerated [1] - A scientific action plan for drug regulation is being implemented to expedite the development of new regulatory tools, standards, and methods [1]

Core Insights - The National Medical Products Administration (NMPA) has approved 204 innovative drugs and 265 innovative medical devices since the beginning of the 14th Five-Year Plan, with 50 innovative drugs and 49 innovative medical devices approved in the first seven months of this year [1][2] - China's pharmaceutical industry ranks second globally, with approximately 30% of innovative drugs under research worldwide [1][2] Group 1: Drug Safety and Regulation - The NMPA emphasizes the importance of drug quality and safety, implementing dynamic supervision throughout the drug lifecycle and establishing a risk consultation mechanism [1] - Special actions have been taken to enhance drug safety, including annual sampling of over 200,000 batches of various drugs and 20,000 batches of medical devices [1] Group 2: Support for Pharmaceutical Development - The NMPA has reformed the review and approval system, introducing four expedited channels for breakthrough therapies and prioritizing certain products for faster approval [2] - The approval of traditional Chinese medicine (TCM) has also increased, with 27 innovative TCM drugs approved during the 14th Five-Year Plan [2] Group 3: Meeting Public Health Needs - The NMPA has optimized the review process for urgently needed foreign drugs, allowing patients to access the latest global drug developments more quickly [2] - A total of 387 pediatric drugs and 147 rare disease drugs have been approved since the start of the 14th Five-Year Plan, addressing the needs of key populations [2]

Core Viewpoint - Liaoning Province is accelerating the quality improvement and upgrading of the biopharmaceutical and medical device industries to support high-quality development in the pharmaceutical sector [1][2]. Group 1: Support for Innovation - Liaoning is providing comprehensive support for drug and medical device innovation, including the inclusion of 3 new drugs and 57 medical device products in a support list, with 134 on-site assistance visits conducted [1]. - One product from the support list has passed the National Medical Products Administration's review for innovative medical devices, while two products have entered the priority registration channel of the Liaoning Provincial Medical Products Administration for market approval [1]. Group 2: Regulatory Optimization - The province has optimized review and approval processes to accelerate the transformation of innovative results, implementing several documents to streamline procedures and reduce inspection frequency [2]. - Since the implementation of these policies, inspections for over 260 companies have been optimized, resulting in a reduction of more than 3,600 working days of enterprise inspections [2]. - Nine second-class medical device products from seven companies have been approved for market entry under the priority registration process, and two products from out-of-province companies have been registered in Liaoning [2]. Group 3: Future Initiatives - Liaoning is striving to become a pilot for the national optimization of drug supplementary application review and approval procedures, with ten technical personnel already passing the assessment by the National Medical Products Administration [2]. - The first pilot in Northeast China is expected to be established in Liaoning soon, which will provide pre-guidance, verification, inspection, and documentation services for major changes in drug applications, significantly reducing the technical review time from 200 working days to 60 [2]. - The Liaoning Provincial Medical Products Administration plans to deepen drug regulatory reforms and support the high-quality development of the pharmaceutical industry comprehensively [2].

Core Insights - Some U.S. biotechnology companies are considering moving early drug trials outside the U.S. due to concerns over FDA staffing cuts and policy changes under the Trump administration, which may delay regulatory reviews [1][2][3] - The FDA has been regarded as the global gold standard for drug regulation, but recent changes have prompted companies to explore international markets like the EU and Australia for drug development [1][2][3] - Executives from various biotech firms indicate that the loss of confidence in the FDA could reshape drug development and increase costs for the struggling biotech industry [3][4] Group 1: Regulatory Environment - The restructuring of the FDA aims to simplify functions and reduce conflicts of interest, but it has raised concerns about the agency's stability [2] - Companies are increasingly seeking to collaborate with the European Medicines Agency (EMA) for drug approvals, reflecting a potential shift in strategy [2][3] - The FDA's recent staff departures have led to fears of delays in the review of trial data, impacting companies' plans for U.S. market entry [5][6] Group 2: Financial Implications - Conducting trials in Europe may incur additional costs, estimated at around $1 million for documentation and support, plus millions more for trial operations [3] - Some companies report that trial costs in Australia can be 30% to 40% lower than in the U.S., influencing their decision to conduct trials abroad [5] - The U.S. market, valued at approximately $635 billion annually, remains critical for companies, but the uncertainty surrounding the FDA may lead to a strategic shift [5][6] Group 3: Industry Sentiment - Executives express that the current situation forces discussions about alternative methods for drug development, with some prioritizing European markets due to high demand [3][4] - Despite the shift, major pharmaceutical companies like GSK, Merck, and Sanofi report no significant changes in their interactions with the FDA so far [5] - The sentiment among investors and executives suggests a cautious approach, balancing the need for U.S. approvals with the realities of the current regulatory environment [6]