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.

The Study of Legal Property of Household Registration System in Our Country

From ＂the case that three girls have some fate but have different value＂ to ＂the case that Hai Cheng took a police substation to court with three times＂, currently the household registration system of our country not only plays the role of account registration and account management, but also undertakes the limitation of migration movement, and for the additional functions of the lowest life guarantee, social insurance, compulsory education, employment and other social security benefits, it also makes a difference between local registered permanent residence habitant and nonlocal registered permanent residence habitant. Just because of these additional functions, the household registration system has become complicated, which originally has clear nature. Therefore, only it is necessary to define the legal nature of our country＇s current household registration system, can executive power be supervised and the rights of citizens get relief.

Study on the development and usage of a cardiopulmonary resuscitation time point recorder

BACKGROUND: To invent a novel cardiopulmonary resuscitation(CPR) time point recorder to synchronously and automatically record the time and to identify its effectiveness in humans.METHODS: A CPR time point recorder was invented after the doctors were familiar with the traditional Utstein recovery registration mode and mastered the registration time points required. The progress of CPR was simulated. The standard and correct times were recorded, and the doctors performing the recovery collected the data about the times using our CPR time point recorder or the memory registration mode.RESULTS: The deviation times were 21.4±24.7 seconds for the memory group and 3.57±4.58 seconds for CPR time point recorder group. The deviation of times increased signifi cantly depending on the increase of the operation items in the memory group. A similar phenomenon was found in the timer group but with a smaller difference(P<0.01).CONCLUSION: A CPR time point recorder could reduce the deviation of operate-time, especially after a long-time operation, and for procedures with more operating items, compared with the memory mode. It was a more advantageous and accurate method for the Utstein registration.

Letter to the editor: Comment on the Regulatios of the Simplified Registration and Approval Management for Compound Recipe of Classical Prescription of Traditional Chinese Medicine

To the Editor:On Oct 9,2017,China Food and Drug Administration announced1~ the Regulations of the Simplified Registration and Approval Management for Compound Recipe of Classical Prescription of Traditional Chinese Medicine(Exposure Draft)which has been stirring up intense debate in the West.The article China to Roll Back Regulations for Traditional Medicine Despite Safety Concerns lately

Implementing of Electronic Medical Record in Pelvic Floor Ward: A Pilot Study

The electronic medical record is an essential technology tool to improve the quality of care. In present study we reported on the design and feasibility of electronic medical records in Female Pelvic Floor Dysfunction Ward. Our main goal was documentation with the least possible missed data, evidence-based decision making, documented active patient follow up and increasing patient’s satisfaction. The Electronic Registry System of Female Pelvic Floor Dysfunction (Vali e Asr Hospital, Tehran, Iran) was designed in mid 2014 and tested till March 2015. The software description was designed based on previous paper questionnaire used in this ward. The electronic questionnaires were filled in upon hospitalization and thereafter including follow ups. The questionnaire included 10 demographic and 15 main questions. A digital analog scale (1 - 10) in each part quantified the effects of problem on patient’s quality of life and also the effects of interventions as well. Entered information in each step was available for those with defined access. Reporting design was dependent on the needed data. Our supervised data entry was a guarantee to the quality of information with the least errors. Access to all para clinical data made rapid and evidence-based decision making. Patient satisfaction was achieved because of unified approach. The most interesting part was access to evidence-based results and data to be used in research projects. This study showed that EMRs in Female Pelvic Floor Dysfunction Wards could provide valuable information, improve the quality of care and increase patient’s satisfaction.

不同扫描范围下3种口内扫描系统的咬合匹配精度对比研究

目的探究不同颊侧咬合扫描范围下3种口内扫描仪之间咬合匹配精度的差异。方法采用3种类型的口内扫描仪(Medit i500、iTero element flex、3 Shape Trios3)对安装于半可调架上的标准石膏模型进行4种不同范围的颊侧咬合扫描。扫描范围分组为Group1:双侧1-3牙位、Group2:双侧4-5牙位、Group3:双侧4-6牙位、Group4:双侧4-7牙位,每组重复扫描10次。对照组采用台式扫描仪获取咬合关系。将实验组与对照组上颌模型进行最佳拟合对齐,下颌模型通过矩阵变换保持初始咬合位置不变。通过三维偏差分析技术分析不同扫描范围对咬合匹配精度的影响。结果同一扫描系统下,i500和Trios3前牙组Group1咬合匹配精密度显著低于3个后牙组Group2、Group3、Group4(P<0.05),且后牙组两两之间差异无统计学意义;同一扫描范围下,咬合匹配正确度在3个口内扫描仪间表现出了相同的趋势:前牙组Group1显著低于后牙组(P<0.05),在后牙组中,随着扫描范围的增大,咬合匹配的偏差减小,正确度提高;使用iTero进行咬合匹配时整体正确度和精密度均优于i500和Trios3,且差异具有统计学意义(P<0.05)。结论不同扫描范围下3种口内扫描系统均会影响咬合匹配精度;iTero咬合匹配精度优于i500和Trios3。

国内外数字疗法产品监管政策与产品应用进展

随着数字技术的不断发展,数字疗法作为一种新兴的医疗手段已经成功应用于精神疾病与部分慢性疾病的管理与防治中。近年来,国内外对数字疗法产品的监管和上市审批开展了研究探索,目前全球数字医疗产品基本按照医疗器械软件进行监管和审批上市。本文先厘清了数字疗法的定义、产品属性与要素,根据数字疗法结合医疗器械和人工智能的特点,梳理总结美国、德国和中国对数字疗法产品的监管政策和产品审评审批上市的通道,调研总结了国内外数字疗法产品上市情况,分析总结了上市产品特点,以期为我国数字疗法产品的监管提供信息支撑。

FDA采用真实世界证据作为主要或唯一证据支持医疗器械上市注册的产品特征分析

随着医疗器械领域的快速发展,传统随机对照试验在评估医疗器械有效和安全性时面临诸多挑战。全球医疗器械监管机构开始探索并采纳真实世界证据(RWE)作为医疗器械监管决策的重要依据。本文对2012~2019年美国食品药品监督管理局(FDA)利用RWE进行医疗器械临床评价的90个案例进行系统分析,重点聚焦于不同审批途径、风险等级产品、疾病领域以及注册阶段RWE的特性。结果表明,近半数产品(44.4%,50/90)将RWE作为注册审批过程中的主要或唯一证据。这些产品主要注册目的集中在上市前批准,疾病领域为心血管疾病,医疗器械类别为Ⅱ类和Ⅲ类。RWE在医疗器械监管决策中越来越重要,尤其是在中低风险医疗器械的上市前审批中。

Registration system reform and initial public offering ownership preference:Evidence from China

Whether registration system reform(RSR)can curb administrative intervention and create a fair market environment has long been a concern in China.We explore this issue from the perspective of the initial public offering(IPO)preference based on the entropy balancing method,and findings are as follows.First,an IPO ownership preference exists under approval system.That is,state-owned enterprises(SOEs)are more likely than private enterprises to obtain IPO approval.However,RSR significantly changes this preference,especially for non-politically connected private enterprises.Second,the post-IPO market performance of SOEs is inferior to that of private enterprises under approval system,thus excluding the view that approval is prioritized for SOEs because of superior performance.Third,compared with SOEs,private enterprises are more likely to switch the issuance system from approval system to registration system;this change makes it easier for them to obtain IPO approval,indicating that private enterprise owners perceive the registration channel to be fairer.Fourth,the effect of RSR on IPO ownership preference mainly occurs in companies in three major urban agglomerations in China—the Pearl River Delta,the Yangtze River Delta,and the Beijing–Tian jin–Hebei region—and in technology-intensive industries.Collectively,our findings reveal that RSR cultivates a fairer IPO approval process.

2021-2024年我国中药注册申请审批情况分析

目的:探讨2020年版《药品注册管理办法》实施以来我国中药研发趋势和注册审评审批的情况,为企业中药研发战略布局提供参考。方法:系统梳理2021-2024年中药制剂注册受理品种,从申报数量、类型、注册分类、治疗领域、剂型、申报阶段等多角度对注册申请和审评审批情况进行分析。结果:中药类注册申请逐年增多,类型以中药新药为主;注册分类涉及中药创新药、改良型新药、古代经典名方、同名同方药,同时也包括天然药物1.1类创新药申请上市的情形;治疗领域多集中在中医优势领域;剂型以口服为主。结论:中药研发企业应加强名老中医优势处方的挖掘,重视已有品种的二次开发,同时结合品种管线和自身优势通盘考虑进行战略布局,抓住中医药高速高质量发展的良好机遇。

混合主义注册制的基础与逻辑

由于审核理念和监管逻辑的不同,对公开发行审核监管可以归结为形式主义的登记制、实质主义的审批制和混合主义的注册制三种模式。以“完全信息披露主义”为理论基础的形式主义登记制放任了对发行人的实质性监管,强调市场功能和效率,削弱了市场公平和投资者保护;以“国家干预经济”为理论基础的实质主义审批制过度强调市场公平和投资者保护,削弱了市场功能和效率;而以“市场化”为理论基础的混合主义注册制是形式主义和实质主义的有效结合,充分吸收了各自优点,既体现效率又体现公平,是公开发行制度的最优选择。在此基础上,本文进一步厘清了注册制下作为审核者的政府与市场、发行人、中介机构、投资者的四对关系。

数字政府建设背景下的不动产登记电子档案单套管理:困境与策略——基于S市区县的不动产登记工作调研

在数字政府建设背景下,不动产登记电子档案管理的规范化和法制化成为提升政务服务效率的关键。问卷调研表明,尽管S市在不动产登记信息化方面取得了显著成效,但在电子档案管理方面仍存在文件管理双套并存、档案管理制度不统一、电子档案四性检测与长期保存等问题。针对这些问题,文章提出了管理理念的转变、电子档案管理制度的系统化构建、电子档案管理模式的协同创新、信息技术的应用保障和绩效评估机制的建立等策略,以提高不动产登记电子档案管理的效率和质量,为实现单套制管理提供支持。

山东省阿胶类保健食品注册批准及生产许可现状与思考

阿胶是一种传统的药食同源产品,在我国有两千年的应用历史,其滋补和养生功能受到越来越多养生者的关注,市场需求极大。本文重点对山东省阿胶类的保健食品的注册批准情况及生产许可现场核查常见问题进行了分析,以期为山东省阿胶类保健食品产业的发展提供技术参考。

药品注册审批工作中专利相关问题探讨

目的:探讨如何正确处理药品注册审批工作中的专利相关问题。方法:分析我国药品注册审批工作中专利相关规定及其存在的问题,并参照美国、欧盟的相关规定进行比较与分析。结果与结论:药品注册审批与专利权保护是相对独立的法律关系,分别适用药品管理法和专利法;药品注册审批与专利侵权之间没有必然联系;专利纠纷应当按照专利法的相关规定解决,药品注册审批工作不应当涉及药品专利纠纷的解决。

药品注册现场核查模式探讨

规范药品注册必须从源头抓起。如何确保药品研制数据的真实,保证药品注册环境的公平、公正,是省局药监部门药品注册管理工作的重心。本研究主要从我国药品注册现场核查的现状出发,纵观美国FDA的药品注册管理体系及现场核查状况,结合我国现行的药品注册法规,探讨药品注册现场核查的新模式、新方法,旨在为药品监管工作提供有益的新思路,从而更好地促进我国医药产业的健康发展,保证人民群众用药安全有效。

股票发行制度的国际比较及对我国的借鉴

股票发行制度的形成和变化既是一个国家或地区证券市场发展内在要求的体现,更是其政治、经济、法律制度的延伸。以英国、德国为代表的核准制和以美国、日本为代表的注册制,是目前成熟股票市场采用的两种发行制度。各国在首次公开发行股票中选择的发售机制也不尽相同,分别有固定价格机制、累计订单询价机制、拍卖机制等。通过借鉴海外主要市场股票发行上市审核制度及其变革的经验,我国发行制度的后续改革应采取渐进而温和的方式,遵循稳定与发展、效率与公平、中国国情与国际惯例相兼顾的原则,不断合理化发行定价机制,并建立发行风险的市场约束机制,分阶段转向注册制,促进一级市场和二级市场协调健康发展。

以电子注册为手段，推进高校学籍管理建设

学籍管理是高校教学管理工作的一项重要内容,是保证高校正常教学秩序,形成良好学风、教风和校风的重要保障。电子注册则是传统学籍管理工作在新形势下的延续和发展。实现电子注册,对保证高等教育质量,维护高校的社会形象和大学生的合法权益,起着很重要的保障作用。学籍管理是实施电子注册的基础,电子注册则是加强学籍管理的有效手段。

论地方性法规的批准与备案制度

“批准”制度使地方性法规的制定程序过于繁琐，并容易在实践中造成混乱，因此，应明确界定批准的含义、标准和程序，或者废除批准制度，代之以备案程序，赋予两类市以完整的地方性法规制定权。审查并不必然是备案的内容，而是法定机关为行使撤销权所进行的一项前置性工作；将审查视为备案的内容反映了人们的一种政治情感并有其现实依据，然而，要克服立法工作中的无序现象，关键是应该尽快启动事后监督制度。

第三类医疗技术取消非行政许可审批后的管理与思考

根据国务院印发的《关于取消非行政许可审批事项的规定》,国家卫生计生委依照《医疗技术临床应用管理办法》,取消了对第三类医疗技术临床准入非行政许可的审批。通过对第三类医疗技术的特性、管理难点与现状及其非行政许可审批制的内涵进行分析,结合近6年来在某三级甲等专科医院的医疗技术管理实践,在国务院取消第三类医疗技术的非行政许可审批的背景下,提出了强化第三类医疗技术管理的5点建议。

新《种子法》对我国草品种审定制度的影响

品种审定是品种管理的核心。因新《种子法》颁布实施,农作物品种审定制度较以往出现了较大变化。本文通过梳理、解读新《种子法》中关于农作物品种审定的条款和现行法律涉及草品种审定的规定,为草品种育种者答疑解惑,明确草品种必须经审定才能推广的规定仍然有效。笔者借鉴农作物品种审定制度改革的思路,对草品种审定制度的完善提出了建议。