Exploration of the Review Standards of Safety Assessment Reports for Ordinary Cosmetics

Cosmetic safety assessment has distinct characteristics of interdisciplinary and extensive intersection,intensive technical knowledge,and high professional requirements.China is confronted with problems such as a lack of professional safety assessment personnel and review personnel for cosmetic safety assessment.The compliance of safety assessment reports has become one of the important factors affecting the process of cosmetic filing and listing.This article contains the comprehensive analysis on the requirements of relevant regulations and technical documents for cosmetic safety assessment,as well as the judgment principles,and specific requirements of safety assessment reports.The key issues in current cosmetic safety assessment and the safety assessment requirements for typical products also are being focused on,so as to help standardize and unify the review standards of cosmetic safety assessment report,and provide reference for cosmetic filers.

Review and Outlook of China Electronic and IT Industry Footprints in IEC International Standardization Activities

Year 2006 is the year marking the 100th anniversary of the founding of International Electrotechnical Commission (IEC). IEC is mainly engaged in the international standardization for electrical and electronic technology field aiming at promoting international trade and technology cooperation and exchange, improving product and service quality, upgrading productivity and protecting the environment as well as human health and safety. Most countries worldwide adopt standards developed and promulgated by IEC, providing a platform to international trade and technical exchange. China has being a member since 1957. Electronic and IT are the most developed and energetic filed in recent decades. Number of IEC TC/SC specialized in electronic and IT amounts up to 52.……

No country is an island in regulating food safety:How the WTO monitors Chinese food safety laws through the Trade Policy Review Mechanism(TPRM)

Established within the framework of the World Trade Organization （WTO）, the Trade Policy Review Mechanism （TPRM） reviews periodically the trade policies of all WTO Members. The review includes many aspects of food safety regulation. China＇s trade policy is reviewed every two years. This paper analyses in detail the reviews of China＇s trade policy in 2006, 2008, 2010, 2012 and 2014. It focuses in particular on food safety laws and types of standards, alignment of domestic standards with international standards, the role of different domestic institutions, transparency and notification of food safety measures under the WTO agreements on Sanitary and Phytosanitary Measures （SPS） and on Technical Barriers to Trade （TBTAgreement）, import and export, and geographical indications （GIs）. It concludes that the WTO TPRM can contribute, within its mandate, to reform of Chinese food safety laws and improvement of food safety in China. it notes that China has already undertaken substantial reforms of its system for regulating food safety. It recommends that China should continue to participate actively in the TPRM, follow its own path with regard to alignment and learn selectively from other WTO Members.

Developing ISO International Standards for the Animal and Vegetable Fats and Oils Sector

Increasing volumes of oils and fats are produced annually with a large section that are traded internationally. The International Organization for Standardization(ISO) body develops international standards covering almost all aspects of technology and manufacturing with 23,882 standards currently published. Standards in the animal and vegetable fats and oils sector is developed by Technical Committee ISO/TC 34, Food products, Subcommittee SC 11, Animal and vegetable fats and oils. Standards are developed through consensus by national members that represent ISO in their country. Each Standard is developed within a determined timeframe and goes through various pre-determined stages such as project proposal, development, national voting and commenting on the draft Standard to final publication. ISO TC34/SC11 Standards range from sampling of oils and fats, sample preparation to analysis of its composition, the minor components, and quality and identity parameters as well as contaminants. The analysis results are used by industry for product development, labelling, research and to provide peace of mind for consumers on its safety. An important future trend is the focus on the safety concerns from either environmental contamination(e.g. mineral oils) or processing contaminants such as esters of 3-MCPDs(3-monochloropropane-1,2-diol or 3-chloropropane-1,2-diol).

Diagnosis of Helicobacter pylori : What should be the gold standard?

Since the discovery of Helicobacter pylori (H. pylori) in 1983, numerous detection methods for the presence of the bacterium have been developed. Each one of them has been associated with advantages and disadvantages. Noninvasive tests such as serology, 13C urea breath test (UBT) and stool antigen tests are usually preferred by the clinicians. Serology has its own limitation especially in endemic areas while 13C UBT is technically very demanding. The stool antigen detection method, although specific, is usually associated with poor sensitivity. The 13C UBT is believed to be specific, but with present revelation of the fact that stomach is colonized by many other urease producing bacteria makes it questionable. Histology, culture, rapid urease test and polymerase chain reaction (PCR) are the tests which are carried out on antral biopsies collected by invasive means. Histology has been proposed to be very sensitive and specific but the question is how by simply looking the morphology of the bacteria in the microscope, one can claim that the curved bacterium is exclusively H. pylori. Rapid urease test (RUT), the doctor’s test, is also challenged because the presence of other urease producing bacteria in the stomach cannot be denied. Moreover, RUT has been reported with poor sensitivity specially, when density of the bacterium is low. Isolation of H. pylori is essential to investigate its growth requirements, antibiotic susceptibility testing, studying virulence factor to develop vaccine and many more explorations. It has also got several disadvantages i.e., special condition for transporting, media, incubation and few days waiting for the colonies to appear, apart from the speed essentially needed to process the specimens. Till date, majority of the microbiological laboratories in the world are not equipped and trained to isolate such fastidious bacterium. The option left is PCR methods to detect H. pylori’s DNA in gastric mucosa, gastric juice, saliva, dental plaques and environmental specimens. There are speculations for false positivity due to detection of non-pylori Helicobacters due to genetic sharing; and false negativity due to low bacterial counts and presence of PCR inhibitors. However, specimen collection, transportation and processing do not require speed and special conditions. PCR based diagnosis may be considered as gold standard by designing primers extremely specific to H. pylori and targeting at least more than one conserved genes. Similarly specificity of PCR may be improved by use of internal Primers. Further, nested PCR will take care of false negatives by countering the effect of PCR inhibitors and low bacterial counts. Therefore, nested PCR based methods if performed properly, may be proposed as gold standard test.

CBL、PBL联合Paper Review教学在胸外科教学中的应用

目的探究CBL、PBL联合Paper Review教学模式在住院医师规范化培训胸外科临床教学中的应用价值。方法选取胸外科2018年12月—2019年12月接受的48名规培生作为研究对象,在临床教学中均实施住院医师规范化培训。根据教学模式的选择,将全部规培生分为传统组和新型组各24名。传统组采用传统教学模式,新型组采用CBL、PBL联合Paper Review教学模式,比较两组实习结束时的考核成绩,调查规培生对相应教学模式的认可情况。结果新型组理论基础考核成绩、技能操作考核成绩和病例分析考核成绩均高于传统组,差异有统计学意义(P<0.05)。在提高综合分析能力、增强临床思维能力、激发学习兴趣、提升临床工作能力等调查方面,新型组持认可的比例均高于传统组,差异有统计学意义(P<0.05)。结论CBL、PBL联合Paper Review教学模式的应用,能够提升住院医师规范化培训胸外科临床教学的效果,增强规培生的综合素质和能力,值得应用。

CBL联合Paper Review教学模式在妇产科规培中的探索

目的探讨CBL结合Paper Review教学模式在妇产科住院医师规范化培训中的应用价值。方法选取30名在中国医科大学附属盛京医院妇产科进行规范化培训的医师为研究对象,随机分为试验组(CBL联合Paper Review教学模式)和对照组(传统LBL教学模式),对比学生出科时理论考试和实践技能考核成绩,并进行问卷调查了解学生的满意度。结果两组的理论知识考试成绩无明显差异,P>0.05,试验组的实践技能考核成绩高于对照组,P<0.05;试验组学生在学习兴趣、自主学习能力、临床病例分析能力、团队协作能力、科研思维培养等方面满意程度均高于对照组,但在学习效率方面,试验组低于对照组,P<0.05。结论CBL联合Paper Review教学模式为住院医师规范化培训教学提供了新的思路。

Effectiveness Life Review on Life Satisfaction among Adolescents under the Supervision of Qazvin Well-Being Center

Objective: The aim of this study was to determine Effectiveness Life Review on Life Satisfaction among Adolescents under the Supervision of Qazvin Well-being Center 2012-2013. Method: This study was a quasi-experimental research including experimental and control groups with a pretest-posttest design. The statistical population consisted of all 12 - 18 years old male students who were nurtured in Qazvin Well-being Center, among whom 16 individuals were selected through applying purposive sampling method and were randomly divided into experimental and control groups with equal number of subjects. The investigation was done using Diener’s (1985) Satisfaction with Life Scale (SWLS) Questionnaire. The experimental group received life review therapy in 6 sessions (90 minutes per session). Data were analyzed by using Analysis of Covariance (ANCOVA), using SPSS software. Results: Results indicated that life review therapy was effective in increasing male adolescents’ life satisfaction living in the welfare center. Conclusion: Life review therapy improves quality of life and life satisfaction;therefore, this treatment can be used as an effective method to improve the living conditions of young people.

PBL、CBL联合Paper Review教学模式在甲状腺外科规培医师教学中的应用

目的:探索PBL、CBL联合Paper Review在甲状腺外科规范化培训中的应用效果。方法:教学对象随机分为实验组(PBL、CBL联合Paper Review)和对照组(传统LBL)。比较两组学员出科成绩、临床能力及满意度测评。结果:实验组出科成绩、临床能力及教学满意度明显高于对照组(P<0.05);结论:PBL、CBL联合Paper Review能有效提高教学质量和学员的临床能力。

Human-Animal Interactions in Disaster Settings:A Systematic Review

This systematic review aimed to assess the current knowledge of human-animal interactions(HAIs)in disaster settings and identify areas for future research.A Preferred Reporting Items for Systematic Reviews and Meta-Analyses search was conducted on three multidisciplinary databases,identifying English-language journal articles published between January 2000and February 2022 that explored the benefits of and challenges associated with HAI in disasters and emergencies.The review analyzed 94 articles using both quantitative and qualitative methods.The review found a paucity of universal terminology to describe the bidirectional relationship between humans and animals during disasters and a failure to include all animal types in every stage of disaster and emergency management.Additionally,research predominantly focused on the health and well-being benefits of HAI for humans rather than animals.Efforts to promote social and environmental justice for humans and their co-inhabitants should support the welfare of both humans and animals in disaster settings.Four recommendations were developed based on these findings to increase the inclusion of HAI in research,policy,and practice.Limitations of the review included the exclusion of pre-2000 articles and all grey literature,limited research examining different combinations of animal and disaster types,and limited research outside of North America.

备案审查联合审查方式探究:从实践渊源和生成逻辑探索结构属性

联合审查,是《备案审查决定》新确立的第五类审查方式。借鉴其他职权行使中采行联合审查的实践素材,正好可回应已有四类审查方式的功能空缺,基于此实践渊源和生成逻辑,联合审查在整个审查方式体系中呈现出其结构属性:其实质在审查职权的联合,不同于作为工作机制的联合审查会议;其途径在关联审查对象,有限依托于人大主导;其功能特点在提高审查质效,目标重点在保障审查效力和实效,而核心关键在协同审查基准。这一方面为进一步论证建构联合审查的重点机制提供了规范原理基础,另一方面,诸如联合审查等“探索”型条款,引入了“完善和加强”备案审查制度的又一种重要的制度化路径,而且,在规范基础上建构规范机制、生成规范内涵,拓展了备案审查释义学的用武之地。

国际中文教育标准建设的问题检视与优化策略

加强国际中文教育标准建设,是推动国际中文教育高质量发展的必由之路。通过梳理国际中文教育标准建设的发展历程可知,我国目前虽具备初步建成较为完善的标准体系、具有一定的自主研发能力等特征,仍存在标准建设的顶层设计有待健全、标准建设不平衡、标准的海外本土化适用度不高、专门用途中文教育标准的研制有待加强、标准建设的理论研究有待深化等突出问题。可以从做好国际中文教育标准建设的顶层设计、补齐国际中文教育标准建设的短板弱项、加强本土化国际中文教育标准的研发力度、重视专门用途中文教育标准的研制和深化国际中文教育标准建设的基础理论研究等方面深入推进国际中文教育标准建设。

出口退税、消费者福利与高水平对外开放

在国际贸易环境不稳定及中国国内构建新发展格局的双重背景下,二十大报告指出要进一步畅通供需双侧循环,持续推进以扩大内需为基本导向的高水平对外开放。如今出口退税对供给及外需侧的研究已得到广泛关注,但关于其对内需侧影响的研究却较少。文章利用2004—2021年产品层面出口退税率数据及中国地区层面价格与工资等数据,考察了出口退税对中国消费者福利水平的影响。研究表明,出口退税率上调会通过降低物价水平即降低消费效应和提高工资水平即增加收入效应来提高消费者福利。进一步的异质性分析表明出口退税的上调对低收入群体及东部地区福利提升水平更大。因此,政府应进一步推进出口退税政策的实施,充分发挥在其促外贸、扩内需的作用,以实现更高水平的对外开放。

国内实验动物福利伦理研究的现状与建议

目的 探究国内实验动物福利伦理的研究现状、研究脉络、演进历程和未来研究方向。方法 以2001年~2023年间CNKI数据库中期刊收录的实验动物福利与伦理相关的文献为数据源,运用文献研读的定性描述和CiteSpace可视化文献计量分析相结合的方法,梳理和归纳实验动物福利伦理领域已查询到文章的概况、热点主题和研究方向。结果 研究表明国内实验动物福利伦理研究热度总体呈上升趋势。研究热点主题包括实验动物福利伦理的基本理论、实验动物福利伦理立法、实验动物福利伦理技术标准、实验动物福利伦理审查、实验动物福利伦理教学研究等方面,并且针对新兴交叉学科引发的伦理问题,在研究内容上不断创新。结论 从实验动物福利伦理法律制度、伦理审查机制、教育与培训、创新研究等层面提出了相关建议,以期为实验动物福利伦理工作提供参考借鉴。

论备案审查内容与标准的体系化

备案审查制度中的审查内容与审查标准应有不同侧重,前者重点统筹审查判断的开展范围和主要情形,包含了审查标准的运用,后者则更强调审查机关在落实各项审查内容时所采用的具体衡量尺度与方法,应对了审查内容的精细化。二者的内涵虽有明显差异,但又协同配合,共同构成审查判断的基础。《全国人民代表大会常务委员会关于完善和加强备案审查制度的决定》的出台,对我国备案审查中的审查内容与标准的体系化意义重大。合宪性、政治性、合法性、适当性四大审查的逐步完备标志着审查内容体系的初步形成,而比例原则的引入则对审查标准的体系化具有重要支撑作用。面向未来,审查内容体系的完善应重点关注内部逻辑和层次结构的融贯与自洽;审查标准的体系化则应在探索比例原则的全阶适用、三层强度划分以及类型化指引下的个案衡量中得到发展。

行政规范性文件不适当备案审查标准之重述

行政规范性文件不适当备案审查标准源于《宪法》的规定,因此,它具有根本法的地位,直接约束行政规范性文件备案审查权。《立法法》《监督法》等法律、法规以及地方立法之间对不适当审查标准进行具体化规定的内容不尽一致,影响了行政规范性文件备案审查标准的统一性与实效性,对此,应当适时启动修法程序解决。全国人大常委会的《备案审查工作办法》《备案审查决定》从合宪性审查、政治性审查和明显不当三个方面发展了《宪法》规定的不适当备案审查标准,对不适当标准具有重述性意义,旨在满足行政规范性文件的品质符合法治国家、法治政府和法治社会建设的要求。

小儿健脾丸的制备和临床研究进展

小儿健脾丸临床用于治疗小儿脾胃虚弱引起的消化不良,症见不思饮食、大便溏泄、体弱无力,是著名的传统中药方剂。文章从制剂工艺、质量标准及临床应用等方面,对小儿健脾丸的研究现状作一综述,论述了优化制剂剂型、全面提升产品质量的必要性,并阐述了小儿健脾丸的临床循证应用情况,以及小儿健脾丸临床应用过程中的辨证论治情况,以期为小儿健脾丸的深入研究及临床应用提供参考。

技术标准的刑法规范效应

补充技术标准、建构刑法规范内容的效应,具有法定化效应和常态化效应两种情形。作为特殊的行政立法种类,技术标准不是法规范,只是行政主体出于裁量权自我规制而制定的行政规则。但是,当前刑法理论否定技术标准规范效应的做法并不可取。技术标准具有科学性、专业性与政策性,值得刑事司法的信赖,而且对于犯罪判断中触及的科学技术问题具有便宜认定的作用,刑事司法适用技术标准也不会违反罪刑法定。所以,刑事司法中技术标准发挥的规范效应具有合理性基础。技术标准属于行政裁量的范畴,基于权力分立与行政自主、行政的专业技术性、避免司法负担过重的考虑,司法对行政裁量的审查是有限度的。刑事司法中法官也不必全面审查技术标准,不用对技术标准的实体内容作出评价。不过,刑事法官可以对技术标准的制定程序与射程范围进行审查判断以合理控制技术标准的规范效应;而对于实体内容显著不合理的技术标准,可以考虑在量刑层面予以一定“补偿”。

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。

国内外卫生健康标准管理体系及制订现状的循证评价

目的了解全球卫生健康标准管理体系及制订现状,为促进我国卫生健康标准高质量发展提供科学依据。方法系统检索相关数据库和标准化机构网站,对目标国家和组织的标准管理体系及制订现状进行分析。结果纳入研究的国家和组织在标准管理体系方面主要实行自愿型标准,仅中国和欧洲的标准化委员会发布了强制型标准。各国卫生健康标准均包含国家、团体、企业三级层面。中、日两国的标准主管机构隶属于政府,其余国家和组织的标准主管机构为独立民间团体组织。在标准研制程序方面,各国家/组织卫生健康标准的制订流程/程序均遵循“立项/提案→起草→征求意见→审查→发布”5个阶段,而具体步骤不尽相同。标准制订现状数据显示,中国发布的标准总数和卫生健康标准总数均位居前列,但卫生健康标准占比仅为2.06%。结论中国与其他国家和组织在卫生健康标准管理体系及制订现状方面存在较大差别,可考虑通过推进标准制订协作机制、加大标准宣贯和实施效果评估力度、强化卫生健康标准研制人才队伍建设、优化标准研制效率和提升卫生健康标准国际化水平等措施,促进我国高质量卫生健康标准的管理与发展。