Research and Enlightenment of Accelerated Approval Pathway in China

Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the accelerated review,conditional approval and breakthrough therapy between China and the United States.Combined with the implementation of accelerated pathway in China,some suggestions were put forward.Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development,which will improve the accessibility of innovative drugs.However,there are some problems in the review procedures and the implementation of supportive documents in China.In view of the above problems and combined with the experiences of US FDA,we should strengthen the construction of institutional system and reviewer team,and improve the efficiency of drug research and development.

Research Progress and Suggestions on China’s Drug Registration Management Based on CiteSpace Knowledge Maps

Objective To analyze the research status and hot spots in the field of drug registration in China,and to provide some suggestions for the follow-up research.Methods CiteSpace was used to conduct literature quantitative analysis on 684 related articles from 2012 to 2022,and the knowledge map was drawn.Based on this,the main characteristics and development trends of the related studies were summarized.Results and Conclusion The number of articles published was closely related to the regulatory policy of drug registration reform.The authors of these articles did not have good continuity.Besides,research hot spots were closely related to the actual work,which was mainly around the improvement of the review and approval policy,encouraging innovative drug research and development,improving the level of new drug development and other directions.The follow-up studies should further strengthen the continuity of research and inter-agency collaboration.In addition,biomedical registration may become a new research focus in the future.

Real-World Evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China

Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.

CONSCLOUSNESS—RAISING OR EXPLICIT INSTRUCTION?——A REVIEW OF CELCE—MURCIA'S“GRAMMAR PEDAGOGY IN SECOND AND FOREIGN LANGUAGE TEACHING”

Introduction There is a general consensus among language learning theorists,educational psycholo-gists,and language—teaching professionals that the learning of anything does not occur in avacuum.That is,successful language learning of whatever kind comes out only when what isto be learned can be meaningfully related to something that is already known.Learning,inother words,must take place within some kind of familiar context or framework——an ex-tension of the familiar to the unfamiliar,if you will.The natural question to raise,then,iswhat such"frameworks"——and ones familiar to the learner——we might identify for thelearning of second/foreign language grammar.In what way,we are entitled to ask,wouldgrammatical consciousness—raising fit into this roughly—drawn,very general picture of lan-

A Brief Review of the Studies on Theories of Foreign Language Writing in China

The 1980s and the 1990s witnessed a slow development of studies on the theories of foreign language writing, English writing namely, in China. At the beginning of 21st century, the development takes a great step forward with more relevant articles published in all kinds of magazines. This review focuses on the articles published in the most important periodicals of foreign language teaching and research since the 1980s. In order to get an over-all understanding of the theories, the author classifies them into two aspects basic theories of foreign language writing and theories of teaching foreign language writing.

Review of Studies of Foreign Language Classroom Anxiety

Anxiety is considered to be one of the key psychological variables as well as one of the important emotional factors that affect language learning. Taken into account that classroom is the main place in which Chinese college students learn English,it is of great significance to study students' language anxiety in the classroom environment. Based on the previous researches, this paper reviews the relevant studies in this area conducted at home and abroad.

Management of rectal foreign bodies: Description of a new technique and clinical practice guidelines

A number of techniques have been described to remove rectal foreign bodies. In this report, a novel endoscopic technique using a pneumatic dilatation balloon normally used in achalasia patients is presented. In addition, a systematic review of the literature was performed for non-operative methods to remove foreign bodies from the rectum. These results are summarised, presented as a practical at-a- glance overview and a flow chart is offered to guide the clinician in treatment decisions. The design of the flow chart was based on the aims to treat the patient preferably on an outpatient basis with minimally invasive techniques and if possible under conscious sedation rather than general anaesthesia.

Impetus for Export-Oriented Economy——Review of foreign capital utilization in Hunan during the Eighth Five-Year Plan period

Since its implementation of the openingpolicy,China has witnessed greatsuccess in foreign fund utilization.Hunan,situated in the hinterland,beganto introduce foreign capital a little later thanthe coastal areas.In 1979,Hunan began toconduct processing and assembling businessand compensation trade,but gained only afew million US dollars.A vast change wastook place in the Eighth Five-Year Planperiod,achieving a great quantitative andqualitative rise in foreign capital utilizationas compared with the sixth and seventh Five-Year Plan periods.In the past five years,Hunan has approved 4,001 foreign-fundedprojects,a 5,5-fold increase over the total forthe previous 12 years(1979-1990),including3,584 projects directly financed by

医疗器械临床试验立项审查环节质量分析及防范策略

立项审查是提高医疗器械临床试验质量的关键环节。通过对立项阶段发现的典型问题以案例的形式进行综合分析。提出,国家药监部门需进一步完善规章制度,申办者应承担临床试验质量管理责任,临床试验机构应建立完善的立项审查机制,研究者应提高规范意识,以保证试验质量和受试者权益。

论审核批准对宅基地强制收回制度的体系构造——兼论《土地管理法》第66条第1款的适用

宅基地强制收回直接关乎着宅基地有偿退出的范围,是新一轮深化宅基地改革的关键性内容。而受制于收回效力认定的不完备性,还应当以对此具有实质影响的审核批准作为类型化的区分标准。其中,作为构成性事实的审核批准,与宅基地收回关系的形成和变更直接相关,能够产生消灭宅基地使用权的法律效力;作为确认性事实的审核批准,则仅确认宅基地使用权是否已经消灭,而不决定或直接影响宅基地使用权的变动。基于此,两类不同的审核批准构成了宅基地强制收回制度的基本类型,从而实现了该制度的体系化构造。

基于“放管服”改革珠江流域水行政“审、批分离”的探索研究

为深入贯彻“放管服”改革,珠江流域各级水行政主管部门积极探索尝试“审、批分离”。结合珠江流域“审、批分离”试行情况,对比分析了现行审批模式和“审、批分离”模式,对比发现“审、批分离”能提高审批质量和审批效率并降低廉政风险。总结了目前“审、批分离”存在的问题,并结合“放管服”改革的要求提出了改进措施建议,为探索推进“审、批分离”提供有益的工作探讨与借鉴。

2023年度数理科学部基金项目评审工作综述

本文总结了2023年国家自然科学基金委员会数理科学部的项目申请、同行评议和资助情况,并总结了科学基金的改革进展。

自然空间何以支持儿童发展?——基于国外研究的系统性文献综述

文章利用系统性文献综述法对相关研究进行分析发现:自然空间支持儿童发展的研究主题呈多样化态势,包括儿童教育、儿童健康、自然感知及童年生活四个方面,但对不同文化背景、经济地位、人口流动等影响儿童与自然空间的探索性研究相对缺乏;研究样本横跨0—18岁的儿童,且以12岁儿童研究居多,纵向研究较少,基于特定条件及编码标准量表分析工具与技术的质性化和跨学科融合。基于此,应考虑儿童与自然连通方式的复杂性,为不同群体儿童提供安全、多元的自然空间;合理制定相关政策和城市规划,建立儿童正式和非正式学习融合的自然友好生态社区;整合教育资源,打造促进未来可持续发展的学校与家庭的一体化自然教育。

国内外语教学翻转课堂研究:范围综述

本文基于范围综述研究框架,以2013—2021年在CSSCI来源期刊和北京大学中文核心期刊上发表的226篇有关外语教学翻转课堂研究的论文为研究对象,采用文献计量法和内容分析法,从文献基本信息、研究主题、发展动态、研究方法、研究内容及实施效果6个维度进行统计分析。研究结果显示:外语翻转课堂研究发文量逐年降低;热点主题演进趋势呈现早期以理论引介为主,中期以本土化应用为主和后期以实证调查为主的发展态势;相关研究以实证类为主,主要采用混合式研究方法;翻转课堂对外语教学总体产生积极影响。现存问题是研究内容相似;研究方法同质性较高,缺乏创新性。

国外外语教学幽默理论回顾、成果总结与未来展望

总结和回顾了国外主流的幽默理论和幽默语言学理论以及外语教学幽默的主要成果,分析了我国在外语教学幽默研究中存在的不足,对今后的发展提出了建议。

数字时代女性的机遇与挑战:国外文献综述与研究展望

性别平等和数字包容已成为数字时代中一个亟待解决的问题,数字化对女性的影响也由此受到广泛关注。文章从数字化为女性创造机遇、带来挑战以及应对措施等方面对相关文献进行综述。对于数字技术对女性影响过于乐观的观点需要批判性地借鉴,可以通过完善市场机制来实现数字化对女性的积极作用,而当前亟须解决的核心问题是利用数字技术变革父权制的性别规范和劳资之间的剥削关系,解决传统社会经济治理模式无法满足女性在数字经济中全面、充分发展的新要求的问题。在此基础上,讨论了对中国的启示。在数字时代,中国面临着与世界其他国家同样的发展机遇和挑战,但面对更为严重的性别角色和性别权力结构的制约,以及户籍制度和市场化、私营经济发展所导致的女性工作条件恶化,女性脆弱性强化等问题。

我国创新药审评审批的改革与发展——以抗肿瘤药物为例

近年来,我国药品监管部门积极采取多项措施,旨在加快创新药的上市速度,以满足广大患者迫切的医疗需求。通过实施附条件批准程序、突破性治疗药物程序、优先审评审批程序等多种加快药物审评审批路径,有效推动了药物研发进程。同时,药品监管科学的不断进步也为此提供了坚实的技术支撑。本文以10余年来我国抗肿瘤药物审评技术的演进与创新为例,阐述了创新药审评评价体系的建立与完善,以期为抗肿瘤药物的审评和研发工作提供指导。未来,药品监管部门将继续致力于推动监管创新,并特别关注罕见肿瘤、儿童肿瘤等领域的创新药研发,坚持完善审评审批体系和提高审评效率,保障广大患者能够获得更多优质、安全、有效的治疗药物。

国外图书馆数据开放实践及启示研究

对国外数据开放现状进行了全面梳理,从自有数据开放、科研数据开放、对政府数据开放的参与、关联开放数据、数据馆员的设立与数据素养教育5个方面,对国外图书馆在数据开放方面的实践进行了总结,并从积极开展图书馆数据监护与治理、制定相应的指导性文件、明确图书馆在数据开放中的定位、以智慧图书馆推动数据开放、拓展数据馆员岗位职责5个方面,阐述了国外图书馆数据开放实践对我国的启示。

《纽约公约》下仲裁协议有效性问题实证研究——以我国法院审查仲裁协议效力为视角

随着“一带一路”建设的深入推进,中国企业参与的涉外仲裁不断增加,中国法院正在积极推动外国商事仲裁裁决的承认与执行。仲裁协议是国际商事仲裁的基础,《纽约公约》明确将缺乏有效仲裁协议列为公约成员国法院拒绝承认与执行外国仲裁裁决的情形之一。2001年以来的中国法院以仲裁协议无效为主要理由拒绝承认与执行外国仲裁裁决的司法实践,具体涉及当事人主体适格、仲裁协议书面形式、仲裁机构约定等因素存在瑕疵。涉外当事人应高度重视法院有关仲裁协议效力的司法认定,注意仲裁协议主体、形式、内容的有效性,避免仲裁协议被认定无效,更好地保障争议解决程序的进行。

基于对同情用药认知现状的调研探索在我国开展同情用药研究的思考

目的:根据中美同情用药经验,调研临床试验从业人员的认知和理解现状,对细化和完善我国同情用药制度体系提出建议,从而更好地满足患者的临床需求。方法:使用自愿抽样、方便抽样等非概率抽样方法,基于现有中美同情用药经验,就同情用药的适用条件、申请和审查主体、患者安全管理、审批流程等方面,对临床试验从业人员的认知和理解进行问卷调查。结果:共收集740份有效问卷。调研结果显示,我国临床试验从业人员对我国同情用药的认知程度有待提高。相关企业和机构人员对我国同情用药的认知与理解存在共性和差异。共性主要体现在对同情用药适用人群、“是否可以向药品监管部门提出同情用药申请”的审查主体、严重不良事件报告义务的承担方、同情用药开展地点以及收费问题的认知等方面。差异主要体现在同情用药的药品条件、申请主体、同情用药期间发生不良事件的补偿或赔偿承担方、美国食品药品监督管理局针对紧急情况下单个患者协议和非紧急情况下中等规模患者同情用药的审批流程等方面。结论:现阶段,我国临床试验从业人员对同情用药的了解不足。不同角色的临床试验从业人员对我国同情用药的药品条件、申请和审查主体、患者安全管理以及审批流程等方面的理解差异较大。因此,鼓励加强同情用药相关政策宣传工作,引导更多满足条件的企业开展同情用药计划,让更多潜在患者获益,同时建议针对理解差异较大的内容进一步明确、细化和完善。