欧盟公告机构用医疗器械类别新框架研究

目的：分析欧盟公告机构用医疗器械类别新框架,为建立我国医疗器械行业相关监管法规提供借鉴和参考。方法：对比分析欧盟医疗器械监管新法规体系下指定公告机构用产品类别新框架与原框架的异同,分析新框架与新法规体系下分类规则、命名系统的相关性。结果和结论：欧盟公告机构用医疗器械类别新框架使公告机构指定范围的划分更为精准合理,新框架中相关条目与分类规则、命名系统的整体化设计思路体现了欧盟整体协调一致的监管法规系统的工作思路。     

全球医疗器械命名(GMDN)软件部分的研究

目的通过研究GMDN的框架、命名规则和数据库特征,对GMDN应用于我国医疗器械监管作适用性评价。方法研究工作分成三个阶段进行。第一阶段:组建工作组,翻译词条。第二阶段:对翻译条目精校,研究分析翻译词条。第三阶段:与子目录的修订工作进行对接。结果 GMDN词条是不同产品要素的集合,比我国的68系列分类子目录的二级产品类别还要细化,但不像我国那样,没有按照一级产品类别进行进一步分类,整体结构就像是个没有分组的数据库,新增的条目按照先后顺序添加到GMDN中。结论研究GMDN的命名方法和结构框架,将对我国医疗器械命名起到积极作用。     

欧盟医疗器械分类原则解析与启示

目的借鉴欧盟医疗器械分类原则,完善我国医疗器械分类规则。方法对欧盟医疗器械分类原则进行分析归纳,对比分析我国现有医疗分类目录和规则。结果与结论详细、具有可操作性的分类原则对我国医疗器械管理至关重要,需要在医疗分类规则中详细规定。     

日本医疗器械一般名称数据库探析

目的：探讨日本医疗器械监管数据库建设与分类命名工作思路,为我国医疗器械监管信息化建设提供技术支撑。方法：解析日本医疗器械一般名称（JMDN）数据库结构层级,分析其分类命名信息。结果与结论：数据库的建立与管理体现了日本医疗器械的监管立足于本国实际,保持与国际监管思路的良好接轨,注重法规的长期稳定性和实际可操作性的工作思路,对进一步完善我国医疗器械信息化建设具有重要借鉴意义。     

《药品和医疗器械行政处罚裁量适用规则》解读

目的 帮助食品药品监管执法人员学习、理解《药品和医疗器械行政处罚裁量适用规则》(以下简称《适用规则》),并在行政执法实践中遵照执行.方法 针对该《适用规则》出台的背景、适用范围、体系结构和主要内容等进行详细分析、解读.结果与结论 《适用规则》的实施,对我国药品和医疗器械行政处罚裁量提供了规范,对提高全系统执法人员的素质和执法水平具有重要意义.     

我国医疗器械行业标准分类问题浅析

目的为医疗器械行业标准体系建设提供参考意见。方法介绍国家标准分类情况,对医疗器械行业标准体系建设中出现的标准分类问题进行举例分析。结果与结论应明确医疗器械行业标准类别的定义,制定标准命名原则和类别判定依据,以保证医疗器械行业标准体系建设以及数据库数据的准确性和统一性。     

我国医疗器械监管法律实践述评

目的为进一步提高医疗器械监管法律实践水平提供参考。方法分析与总结我国医疗器械监管法律实践的内容以及得失。结果与结论医疗器械监管部门应该与时俱进,接轨国际规则,从立法和执法两个层面全力改善我国医疗器械的法律实践环境。     

关于推进医疗器械质量受权人制度的情况分析与思考

<正>医疗器械质量受权人制度是医疗器械生产企业授权特定的质量管理人员对企业质量管理活动进行监督和管理,对医疗器械生产的规则符合性和质量安全性进行内部审核,并由其承担医疗器械产品放行责任的一项制度。目前,我市已在所有医疗器械生产企业中推行了该项制度,我们也就该项制度实施过程中出现的一些共性问题进行了分析和思考。     

医疗器械监管与认证的关系探讨

目的探讨医疗器械监管与认证的关系,为完善我国医疗器械监管和认证体系提出建议。方法分析我国医疗器械监管与认证的关系,结合其发展的历程,并与国外先进国家进行对比。结果和结论我国应在具有我国特色的医疗器械监管体制基础上,学习和借鉴国外先进经验和成功做法,合理规划医疗器械监管部门和医疗器械质量认证机构的关系,逐步建立并不断完善符合国际惯例和市场经济规则的有效的监管体系和认证制度。     

2017至2023年我国医疗器械审评审批制度改革评析

作为医疗器械安全治理的制度安排,审评审批制度改革对于医疗器械创新发展具有重要意义。文章从确立核心价值理念、变革医疗器械上市准入规则、调整组织结构、完善技术审评流程、健全技术审评质量管理体系和发布技术指导原则等方面,总结医疗器械审评审批制度改革的实践做法,并实证评估了2017至2023年期间第三类医疗器械注册审评用时与质量,观察到医疗器械注册质量体系核查提高了审评效率;医疗器械注册电子申报提高了技术审评信息化水平;补充资料通知单发放数量、第三类医疗器械审评用时在不断下降,确保了审评效率。同时,对重点省份的改革举措以及审评审批制度对企业的影响也做了分析。建议持续推进质量体系建设,提高创新能力、人才队伍建设水平与审评服务能力,以提升医疗器械创新水平。     

国内外生物制品通用名命名体系的比较与分析

目的：为修订我国生物制品通用名称命名原则及明确命名工作程序和技术要求提供科学合理的技术参考和建议。方法：采用文献资料法,对国际药品通用名称、美国通用药品名称、英国药品通用名称及中国药品通用名的通用名称命名体系的命名原则、申报要求等进行全面比较和分析。结果与结论：概述了各通用名称命名体系、命名原则、命名工作程序及技术要求等的异同点,为我国生物制品通用名称命名原则的修订工作奠定了基础。     

抗体类生物类似药命名管理及其影响分析

目的 规范我国抗体类生物类似药命名,完善其全生命周期管理体系。方法 深入研究世界卫生组织（World Health Organization,WHO）、欧盟、美国、日本及我国关于抗体类生物类似药的命名要求,分析不同命名方式对药品全生命周期管理的影响。结果 目前,国内外抗体类生物类似药的命名原则不尽相同,但总体遵循WHO的国际非专利药名系统不同的命名方式将对处方安全性、药物警戒、医保准入与支付等方面产生影响。结论 建议药品监管部门逐步与国际接轨,基于国际非专利药名系统并结合我国实际情况尽快出台生物类似药命名相关文件,以明确抗体类生物类似药命名。此外,建议加强药物警戒管理、制定科学审慎的生物类似药医保支付决策,从而构建生物类似药尤其是抗体类药物的全生命周期管理体系。     

Naming, labeling, and packaging of pharmaceuticals.

The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.     

各国生物类似药命名原则的比对研究及完善我国生物类似药命名原则的建议

对生物类似药名称进行规范管理不仅有利于医生处方和患者用药的准确性,更重要的是利于药品上市后不良反应的可追溯。对美国、欧洲、日本、韩国等国家或地区以及WHO生物类似药命名方式、命名技术要求进行比对研究,尽管各国生物类似药的命名方式有所不同,但"可区分"是各国共同遵循的原则。在对比研究的基础上,结合我国命名、处方管理相关要求、问卷调研和专家研讨,提出完善我国生物类似药命名原则的建议。     

Effects of nicotine gum on repeated administration of the stroop test

Using a double-blind procedure, 24 non-smoking subjects chewed either 2 mg nicorette® gum or a placebo for 20 min, before completing a Stroop test on three occasions. Colour-word reading and simple colour naming times were consistent across repeats, and were unaffected by nicotine. However, the time taken to name the colour of incongruous colour word stimuli declined across trials. This increase in speed across repeats was significantly greater in those subjects who had received nicotine. These data are consistent with previous reports of a decreased Stroop effect following nicotine administration, but are not compatible with a simple model which assumes that nicotine alters the way in which information is filtered by selective attentional mechanisms. The present results can be explained by postulating that nicotine influences either the rate at which colour naming become more automatic, or changes the way in which resources are allocated to non-automatic processes.     

EMCDDA framework and practical guidance for naming synthetic cannabinoids

Synthetic cannabinoids (SCs), often sold as “legal” replacements for cannabis, are the largest group of new psychoactive substances monitored by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Currently, close to 240 structurally heterogeneous SCs are monitored through the European Union (EU) Early Warning System, and attributing consistent, informative, and user-friendly names to SCs has been a challenge in the past. Over time, several naming conventions have been employed with the aim of making SCs more easily recognizable by non-chemists, including regulators. To achieve this, the names assigned need to contain detailed information on the structural features present in the substance. This work provides a theoretical framework and a practical hands-on guideline for consistent naming of SCs, which is easy to understand and can be applied by the forensic community, researchers, clinical practitioners, and policy-makers. The proposed framework builds on the established letter code system for molecular building blocks (core, linker, linked group, and tail) implemented by the EMCDDA in 2013 and has been expanded to incorporate additional structural features through substitution. The scope of the issue of attributing semi-systematic code names is illustrated, and earlier approaches used for naming SCs are discussed. The concepts and rules of the EMCDDA framework are described through a flowchart that provides a basis for naming new SCs, a graphical overview of the chemical diversity of SCs, and a detailed list of the SCs identified in the EU by the Early Warning System of the EMCDDA for reference.     

The smoking Stroop and delay discounting in smokers: effects of environmental smoking cues

We investigated the effects of exposure to environmental smoking-related cues (holding a lit cigarette in an environment previously associated with smoking) on cigarette craving, colour naming of smoking-related words in a modified Stroop task, and on the delay discounting of hypothetical rewards, in daily cigarette smokers (N = 30). Compared to exposure to neutral cues, exposure to smoking-related cues was associated with increased cigarette craving and slower colour naming of smoking-related compared to matched control words. However, smoking cues had no effect on delay discounting. These results suggest that smoking cues increase craving and the ability of smoking-related words to grab the attention, but do not influence impulsive decision-making. Theoretical and clinical implications are discussed.     

百岁老人的认知能力和主观幸福感及其影响因素调查

目的了解萧山区百岁老人认知能力和生活满意度的现状及其影响因素。方法运用自编问卷[包括一般人口统计学资料和主观幸福感（SWB）]、简易智能状态测查（MMSE）及日常生活能力量表（ADL）对全区55位百岁老人进行人户调查，应用相关分析、t检验和线性回归分析等统计方法对数据进行统计。结果（1）百岁老人的主观幸福感普遍较高，认知功能中保持最好的是物体命名能力，注意力和计算力较差；（2）认知能力与日常生活能力得分存在显著负相关，而与性别、生活方式、宗教信仰等无明显关系；（3）主观幸福感与认知能力、性别、生活方式、宗教信仰等无明显联系，但与日常生活能力得分有明显负相关，与年龄、家庭关系有明显正相关；（4）家庭关系和日常生活能力是影响主观幸福感的重要因素。家庭关系融洽对主观幸福感的形成发挥积极作用，而日常生活能力下降对主观幸福感的形成起消极作用。结论百岁老人认知能力中物体命名能力保持很好，注意力和计算力较差，总的认知能力与日常生活能力存在密切关系。老人的幸福感相对较高，家庭关系和日常生活能力对幸福感的形成起直接影响。     

浅谈西药片剂质量标准

本文结合日常的药品监督检验及药品注册标准复核工作中发现的问题,就西药片剂的命名及质量标准中相关检验问题进行探讨,为片剂质量标准的科学、合理、规范的制定和修订提供参考。