我国药品监管体系框架及构成要素研究

目的:构建我国药品监管体系的理论框架,并探讨其构成要素。方法:采用文献法、比较法和归纳法进行分析。结果:我国现行的药品监管体系主要包含药品行政垂直监管组织体系、药品监管决策支撑体系、药品监管人力资源管理体系、药品监管法律保障体系、药品监管信用保障体系五大要素。结论:除药品监管信用保障体系处于起步和探索阶段外,其它体系目前已基本建立并处于逐步完善过程之中。建立健全药品监管信用保障体系是药品监管部门的当务之急。     

监管科学视角下国外药品监管人才能力与素质研究以及对我国人才培养的思考

近年来,国家大力推进监管科学发展,我国监管科学发展方向和发展路径已初步形成,新监管态势将会对药品监管人员提出新的和更高的要求.本文通过研究监管科学的本质和新时代下监管科学功能和特点,结合国外对药品监管科学人才能力与素质的要求、人才重点培养方向以及具体实践内容,为我国监管科学人才能力的培养和素质的提升提出建议.     

行政许可法律框架下的药品监管研究

本文通过对《行政许可法》实施后,我国药品监管实际中出现的诸多问题进行分析研究,以期对我国药品监管行政许可制度的完善提出构想。     

推进药品监管体系和监管能力现代化：药品监管能力基准评估的国际经验

目的：基准评估作为一种提升监管能力的手段,已经被监管机构广泛运用于推进药品监管能力建设。本研究旨在基于国际监管能力基准评估方法和工具,系统性地梳理推进药品监管能力的评估指标和分析相关的国际应用经验。方法：将发布了具体的监管能力基准评估方法或工具的世界卫生组织、欧洲药品监管机构负责人组织、经济合作与发展组织、国际监管科学创新研究中心、美国政府问责办公室纳入研究,分析上述组织/机构官网报告和相关文献,采集、剖析相关数据。结果与结论：本研究综合对比、分析了现有的基准评估指标体系,建立了全面评估框架及指标,为药品监管机构建立基准评估工具提供重要的参考依据。药品监管能力基准评估工具通过多元化指标体系,整体评估国家监管体系、利益攸关方参与、监管效果评估和事后行为,同时从药品全生命周期中各运营层面细化评估注册及上市批准、上市后监测、药物警戒、许可申请及发放、监管稽查、实验室规范、临床试验监管和批签发。从应用层面看,不同发展阶段的国家监管机构已分别运用不同的基准评估工具进行内部基准评估、外部基准评估、职能基准评估或流程基准评估识别监管绩效,从而提升监管实践。基于基准评估结果,有针对性地配置资源进行持续...     

我国药品监管质量管理规范建设原则和框架探索

药品监管质量管理规范(GRP)建设,是增强药品监管部门执行力公信力、提升药品全生命周期管理能力、降低药品技术性贸易壁垒和推动药品监管职能转变的制度基础。基于我国GRP实施现状、国际组织互认协议和部分地方政府监管体系等比较分析,本文对GRP体系的分类与原则、建设内容和制度框架进行开拓性研究,提出GRP建设的国际互认协议、协调层级、地方制度创新、市场监管卫生健康制度移植和数字化流程再造等原则,以及基于组织协调、工作流程、专业知识的GRP建设霍尔三维空间结构,GRP规范/指南编制的综合评价方案。     

药品监管公务员专业化的含义及其能力要求初探

建设高素质、专业化的药品监管公务员队伍是药品监督管理基础性、战略性的任务。我国药品监管公务员队伍组建的时间不长,队伍的专业分布、学历层次与知识结构都与药品监管职能的要求存在着一定差距。针对这一问题,在大量调研的基础上,对药品监管公务员专业化的概念、含义以及其能力要求进行深入探讨。     

智慧药品监管平台评价模型的构建与应用研究

目的 针对当下智慧药品监管平台发展的具体情况,构建了智慧药品监管平台评价研究模型,以此探究智慧药品监管平台的完善水平和未来方向,更好地推动我国药品信息化监管的发展.方法 通过对影响智慧药品监管平台完善水平的各个因素的分析,建立了智慧药品监管平台评价指标体系,采用基于模糊群策法和多指标分析法构建了智慧药品监管平台评价研究...     

药品质量抽验机制与药品质量(Ⅱ)

随着医药经济的飞速发展和药品监管任务的日益繁重，现行药品抽验运行机制与“经济必要、突出重点、分工合理、追踪问效”的抽样原则不相适应的矛盾越来越突出地显现在我们面前，并将继续困扰我们。2004年6月，国家食品药品监督管理局局长郑筱萸在全国食品药品监督管理工作座谈会上指出，要以科学发展观统揽食品药品监管工作全局，要整合监管资源，增强监管合力，提高监管效率。这为我们客观正视、深入研究并着力解决这一矛盾指明了方向。     

美欧日药品监管趋势对中国药品监管变革的启示

通过检索并分析旧内外一手文献,梳理了上个世纪九十年代以来,美国、欧盟和日本这三个全球最大的医药经济体在药品监管实践中的最新进展和重大变革趋势,结合国内药品监管实践,探讨了中国药品监管变革的路径。作者认为,在全球化时代,国家食品药品监督管理总局应该实施全程化监管,尤其是加强上市后监测,通过提高监管科学以改善决策,提供更好的服务以促进产业发展,并加强国际交流合作,使监管标准与发达国家保持一致,从而促进药品安全。     

基于监管视角的药品生产企业分级监管模型构建

目的：建立药品生产企业分级分类监管模型,为建立适合我国药品生产监管实际的分级监管策略提供方法借鉴。方法：依据分类管理理论,以企业风险水平、企业监管记录和监管频率分析研究为基础,对药品生产企业分级监管模型及其参数进行建立和优化。结果与结论：针对药品生产企业的监管需求与药监部门监管能力之间不相适应的矛盾日益突出等问题,通过分级模型的建立和优化,实现了监管能力和监管需求的良好匹配。     

Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners

In today’s globalized drug development landscape, the need for regulatory professionals to be more seamlessly integrated into strategic decisions is evident. Whereas a few companies see the benefit of involving regulatory affairs professionals in strategic business decisions, many still lag behind. Limited literature and scholarly discussion is available on whether regulatory affairs professionals are given the stature and power to make a meaningful contribution during strategy formulation across all stages of the product development, launch, and life-cycle management. This article examines the current business environment for the regulated industries; discusses why it is important that regulatory affairs play an active and strategic role in this sector; and proposes a new educational perspective to facilitate the recognition and acceptance of regulatory affairs professionals as strategic partners.     

药品合理分类及药品监管制度在医院西药房管理中应用的意义

目的 探讨药品合理分类及药品监管制度在医院西药房管理中的应用价值.方法 以相关规定和药品说明书等为参考,对本院西药房的药品进行合理分类,并且加强药品监管制度.观察比较药品合理分类和加强药品监管制度改进前后各12个月（分别为2011、2012年全年）的药房差错率和患者满意度.结果 2011年1～12月的药房差错率为1.64％,患者满意度为80.31％;2012年1～12月的药房差错率为0.49％,患者满意率为97.83％;两个时间段的药房差错率和患者满意度比较,差异有统计学意义（P＜0.05）.结论 西药房管理中对药品进行分类,加强监督管理,可降低药房差错率,提高患者满意度.     

Constraints of drug regulation on the development of new drugs

A review is given of the various regulations for the preclinical and clinical evaluation of new drugs, their effects on the clearance of new medicines for general use by practising physicians, and their repercussion on industrial drug research. Undoubtedly, extensive and continuously increasing regulatory procedures, which in addition have to be satisfied repeatedly in individual countries, claim an unproportionally high percentage of the industrial capacity for research and development of new drugs, leaving too little for basic research, which is a prerequisite for the discovery of new medicines that are more than just me too products. Despite the fact that regulatory language differs from scientific attitude and arguments, the wall of regulations should be neither too thick nor too high to impede research and to hinder the prompt application of important new drugs. Even the most sophisticated and extensive drug regulations cannot prevent the use of drugs which is not indicated, because it is impossible to regulate ignorance. To regulate drugs is necessary, but the governments and their drug agencies should also encourage drug research and should support industry in the development of new drugs. On the other hand, the drug companies must adhere to the accepted standards and create an atmosphere of confidence by presenting reliable and complete data.     

Demonstrating institutional trustworthiness: A framework for pharmacy regulatory authorities

BackgroundSelf-regulation is well suited for health care providers as the distinctive knowledge requirements can be effectively managed by those with the specific knowledge base compared to national or provincial/state governments. Despite their prevalence and long history in health care, self-regulating professions have become a topic of increasing debate as a result of evidence of declines in trust in a number of institutional contexts.ObjectiveIt is important that Pharmacy Regulatory Authorities (PRAs), as the regulating body for a critical health profession, can demonstrate and proactively respond to issues related to public trust. Such capabilities are needed to address an overall decline in trust in self-regulated professions and allow PRAs to quickly address issues that may impact public trust within their own jurisdiction. However, a process and best practices that allow PRAs to demonstrate institutional trustworthiness to the public is lacking. Given the need from both a research and practice perspective, this research develops a conceptual framework of how PRAs can demonstrate institutional trustworthiness to the public.MethodsThe literature was reviewed to identify dominant themes associated with regulatory practice that would serve to demonstrate institutional trustworthiness of PRAs to the public. Eight best practice themes emerged: public interest objective, transparency, engagement, accountability, independence, collaboration, adaptability, and awareness.ResultsThe conceptual framework is comprised of six key steps, related to defining public interest orientation, implementing trust-related best practices, developing a communication strategy to increase public awareness of PRA activities, monitoring symbolic capital, assessing public trust in registrants (interpersonal trust), and assessing public and registrant trust in the regulator (institutional trust).ConclusionFuture research should develop pharmacy-focused instruments related to trust, establish baseline measures of registrant and public trust in pharmacy regulatory authorities, and explore issues of public trust in PRAs between different cultures and developed and developing countries.     

Evolution of drug regulations and regulatory innovation for anticancer drugs in China

Over the past two decades, China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals, keeping in line with the rapidly growing scientific innovation in drug research and development (R&D). In this study, we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998. More particularly, we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021, as a powerful illustration of how the revolution has changed the drug R&D landscape. Innovative drug development in China has boomed, benefiting in particular from pro-innovation policies as well as expedited program designations by the authority. We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021, with the emergence of drugs with novel mechanisms of action, including immune checkpoint inhibitors and cell therapy products. Drug lag has also been dramatically shortened by more than 70% for imported drugs in years 2016–2020 compared to years 2006–2010. Furthermore, we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China. This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.     

A conceptual framework for transferring research to practice

Systematic evaluations of efforts to transfer research-based interventions and procedures into general practice at community drug treatment programs have been limited. However, practical experiences as well as results from studies of technology transfer and organizational behavior in related fields provide a basis for proposing a heuristic model of key factors that influence this process. The successful completion of four stages of activity typically involved in program change (exposure, adoption, implementation, and practice of new interventions) appears to be influenced by several organizational considerations (e.g., institutional readiness for change, resources, and climate) as well as staff attributes. Assessment instruments for measuring organizational functioning (based on ratings aggregated for staff and patients in a program) are introduced, along with preliminary evidence for their validity. A better conceptual understanding of the process of program change and common barriers that may be encountered is needed for effectively transferring research to practice.     

Orphan drug development: The impact of regulatory and reimbursement frameworks

The enactment of orphan drug-specific legislation pioneered by the USA was subsequently followed by many regions, including the European Union (EU), Australia, Japan, and Taiwan. Here, we discuss the associated regulations established and their impacts in the aforementioned regions, which are among the first with frameworks specific for orphan drugs. Varied scopes of rare diseases or orphan drugs, diverse incentives, and heterogeneous types of reimbursement systems imply the prioritization of the agencies concerned. The numbers of designated and approved drugs reflect the impact of the regulatory and reimbursement frameworks. A comparison of the frameworks and their impact in the respective regions could provide valuable information for developing and improving related frameworks for countries worldwide.     

The federal role in drug abuse technology transfer: a history and perspective

The past 30 years have seen a focus on substance abuse research in association with the creation of federal agencies specifically mandated to guide that effort. While research has been well supported and largely productive, there has been increasing concern with the slow pace of adoption of the findings from that research. The history of those efforts suggests a long-standing concern with knowledge development, and a continuing reliance on print media to achieve knowledge application. Nonetheless, evidence from other human service fields, and increasingly from the substance abuse field, indicates interpersonal strategies are dramatically more effective in achieving the individual and organizational behavior change needed to achieve technology transfer. Argument is made that the federal government remains the best, if not the only resource for promoting technology transfer. A paradigm is described to further federal efforts in this area, and structural elements suggested for the achievement of technology transfer goals.     

Brain safety concerns of nanomedicines: The need for a specific regulatory framework

There is growing interest in using nanomaterials as carriers for the delivery of drugs in diseases such as cancers and central nervous system (CNS) disorders. Although several nanomaterial-based products have been approved, the regulatory framework for their use in humans remains limited. Nanomedicines (NMs) are usually not designed to cross the blood–brain barrier (BBB). Given the lack of a comprehensive set of standardized methods to assess their in vivo fate, there is an urgent need to characterize NM biodistribution as well as the toxicity that could result from their interaction with the CNS. Here, we discuss the risks of potential unwanted BBB crossing and brain toxicity of nanocarriers (NCs), along with the safety assessment and current regulatory challenges related to NMs.