国外已上市连续制造药品的注册审评情况及其启示

目的：借鉴国外已上市连续制造药品的注册审评要点,为我国推进药品连续制造相关监管法规、 技术指南和标准制定等方面提供参考。方法：调查研究全球已上市口服固体制剂连续制造产品在注册过程中的工艺评估及审评情况,结合案例分析和连续制造相关的法规要求,梳理连续工艺产品在注册和审评过程中的关注点。结果与结论：药品连续制造在国外已经有较为成功的应用,监管部门应重视与业界早期沟通,并在审评阶段重点关注批量的定义、工艺验证、技术转移等研究资料。随着ICH Q13的落地实施,建议我国借鉴国外已上市连续制造药品的工艺评估情况并结合相关法规要求,制定符合国情的注册审评指南。     

我国体外诊断试剂产品注册管理现状分析

目的：对体外诊断试剂产品中注册管理相关法规和技术文件进行梳理、总结和分析,有利于从业人员和监管人员全面掌握注册制度的关键环节和配套要求,提升体外诊断试剂产品监管的科学性、准确性,提高企业开展相关产品注册的效率和质量。方法：从监督管理变化视角对注册管理办法的产品分类规则、执行标准、临床评价、审查指导原则、特殊审批程序等监管内容进行解读,分析体外诊断试剂行业的前景与面临的问题,阐释修订后的法规在保证体外诊断试剂安全有效、质量可控方面起到的明显成效。结果与结论：通过对体外诊断试剂产品注册管理法规进行修订,实现了对分类规则的调整,解决了部分产品分类与其风险不匹配等问题,完善了产品执行标准,使标准发挥出技术支撑作用,贯彻落实企业主体责任,加大临床试验管理力度,发布审查指导原则,补充特殊审批条件,在保证体外诊断试剂的安全、有效、质量可控方面发挥了显著作用,对我国体外诊断试剂整体行业的发展产生了深远影响。     

人工智能医疗器械辅助诊断及探测性能评估参数的讨论

目的：人工智能医疗器械的应用越来越广泛,但目前并没有对其性能的评价标准。希望通过本文研究为人工智能医疗器械的客观评估提供帮助。方法：从不同的应用角度对人工智能医疗器械评估参数进行了梳理,比较了各个参数的特点和使用场景。结果与结论：不同的评估参数所适用的场景不同,评估结果也存在差异,在进行人工智能产品评价时应根据产品特性合理选择。     

我国已上市治疗用生物制品整体情况分析

目的：梳理我国已上市治疗用生物制品的整体情况,提炼出存在的问题,为行业提供参考信息,同时为完善我国治疗用生物制品注册管理制度体系提供数据支持。方法：基于我国已上市治疗用生物制品的数据,进行统计分析和对比分析。结果：对我国已批准治疗用生物制品信息进行了整合,并从批准上市产品的发展历程、创新程度、技术类别等不同维度进行了全方位深入分析。结论：与发达国家相比,我国治疗用生物制品的研发和产业化相对较晚,市场规模较为有限,但增速显著高于全球水平。     

新法规背景下境内药品再注册的技术审查标准研究

目的 构建新药品注册法规背景下境内药品再注册的技术审查标准。方法 通过分析药品法规和审查案例，初步确立境内药品再注册的审查要素，并采用改进德尔菲专家函询法，对33名药品注册审查专家进行2轮函询，统计分析函询结果。结果 制定了一套境内药品再注册的技术审查标准，包括8个一级要素、41个二级要素。结论 本研究构建的技术审查标准有望促进药品再注册技术审查工作的规范化，提升药品再注册技术审查质量。     

仿制药一致性评价及其评价过程的质量管理

目的 探讨仿制药一致性评价过程的质量管理,为中国制药企业高效开展一致性评价工作提供参考。方法 阐述一致性评价的基本概念,对仿制药一致性评价的发展阶段和关键步骤进行梳理,提出PDCA循环管理模式在一致性评价过程中的应用。结果 运用PDCA循环管理模式对评价过程进行全面质量管理,可以制定出一致性评价的科学程序。QbD设计管理理念和cGMP生产管理理念的应用,可以保证产品从研发到生产全过程的一致性。结论 以QbD和cGMP理念为重点的PDCA循环管理模式可在中国制药企业一致性评价过程中加以应用,从而加强仿制药一致性评价过程的质量管理。     

香港澳门药品注册管理的比较研究

目的：将香港澳门的药品注册管理进行系统的比较研究,为内地药品到港澳上市提供参考。方法：运用文献研究和政策分析法,对港澳地区的药品注册管理体系、药品注册要求以及注册申报程序进行对比分析。结果：港澳的药品注册管理机制不同,香港的药品管理法律体系呈平行管理的特点,对中西药独立监管注册,中药实行中成药注册分类制度,并根据注册组别不同提交不同资料;而澳门的药品法律体系尚未统一,对药品集中注册管理,实行预先登记机制,中药实行中药预先许可制度。结论：内地药品在港澳注册上市,有利于提高内地企业的国际化和药物研发水平;内地企业在港澳申请注册时,应熟悉港澳药品注册管理政策,并与当地经销商合作,积极开展国际多中心临床试验;而提高内地企业药品研发质量,促进三地临床数据互认,有利于实现三地互利共赢的目标。     

新发传染病相关的药品技术战略储备思考

目的： 对新发传染病相关的药品技术战略储备进行探讨,旨在为战胜此次新冠肺炎疫情,更为下一次可能的疫情做好准备。方法： 梳理了世界卫生组织、欧盟、美国对与公共健康威胁相关的药品技术储备情况,主要阐述了新发传染病相关的疫苗技术储备信息,给出WHO建议的新型冠状病毒肺炎（COVID-19）药品研发信息,EMA在公共健康威胁（例如大流行性流感）相关药品方面的技术储备情况,并总结了EMA对大流行防备疫苗的技术要求。结果与结论： 建议在我国建立由国家主导并投资的与公共健康威胁相关的预防用疫苗或治疗用药物的技术和产品战略储备,例如为新发传染病的疫苗开发制定清晰的计划、法规和程序。药品技术和产品的战略储备可包括：1）政府部门制定与公共健康威胁相关疾病的清单,例如可能引起重大流行病的突发疾病用药优先研发清单;2）审评审批方面可考虑制定大流行性疾病疫苗（包括大流行防备疫苗）、大流行性疾病治疗药物研发的技术要求,涉及质量、非临床、临床、申报程序等内容;3）通过国家科技立项等方式投资预防用疫苗及治疗用药物的研制;4）引导生产企业进行相关的药品战略储备。     

我国药品加快上市注册程序的注册情况分析

目的：对2020年新修订的《药品注册管理办法》颁布前后我国纳入药品加快上市注册程序并已批准上市的药品信息进行分析,为完善我国药品加快上市注册程序提供参考。方法：检索国家药品监督管理局药品审评中心发布的2019-2021年度药品审评报告,对通过优先审评和药品加快上市注册程序而上市的相关药品数据资料进行信息整理和汇总分析。结果：通过药品加快上市注册程序的上市药品数量逐年增多,优先审评审批资源向临床优势药品和创新药品倾斜。结论：药品加快上市注册程序可为临床价值显著的药品提高审批效率,在一定程度上激发制药企业研制热情,但药品加快上市注册审批体系仍需进一步完善配套政策,细化实施要求,加快专业指南出台,鼓励以临床价值为导向的药品的研发创制, 不断提升药品监管部门的服务和监管能力。     

我国执业药师执业领域相关问题的研究

摘 要 目的：探讨我国执业药师执业领域的定位,提出改革建议。方法: 对我国执业药师执业领域进行定性分析和开展国际比较研究。结果: 我国执业药师管理相关法律法规对执业领域规定不系统,专家学者对执业药师执业领域定位有观点分歧。结论:应加快推进执业药师立法,在法律层面理顺执业药师执业领域。应将我国执业药师执业领域规定为药品生产、经营和使用领域,对药品零售企业和医院药房实行统一资格准入、分类注册,对生产企业实行鼓励性配备政策,对没有在执业领域内工作的获得执业药师资格人员设置非执业注册程序盘活注册资源。     

Perceptions of cannabis health information labels among people who use cannabis in the U.S. and Canada

BackgroundThe emergence of legal cannabis industries poses a new public health challenge. Health information labels are part of the public health strategy for tobacco and alcohol, but there is limited research on cannabis-related messaging. This study explored perceptions of cannabis health information labels among people who used cannabis in the last 12 months residing in the U.S. and Canada.MethodsThe Global Drug Survey (GDS) is a large anonymous cross-sectional web-survey. In GDS2019, respondents were presented with six labels with cannabis-related health information (dependence; driving stoned; harms of smoking; harms to developing brain; lack of motivation; effects on memory), and asked if information was new, believed, would it change behavior, and about acceptability of having health labels on legal products. This paper includes 1,275 respondents from Canada and 2,224 from U.S. states where cannabis was legal at the time of the survey, and 5,230 from other U.S. states.ResultsFew respondents said that the information was new (6.6-24.6%). Most said the information was believable (63.5-72.0%) other than for the dependence message (28.1% new, 56.8% believed), which was perceived to be the least likely to change behavior (10.2%). Driving stoned was the message perceived to be the most likely to change behavior (58.5%). Respondents living in Canada were less likely to say information was new and rated most messages more believable than those in the U.S. Respondents from legal U.S. states were less likely to say information was new compared to other states. Respondents who used cannabis daily rated acceptability of labels lower (27.8%) than those using 1-48 days (40.6%).ConclusionsNovel, believable information may be more effective at changing behavior. Regular consumers may be less susceptible to messages. Information focusing on safer use strategies and benefits of reducing use may be more acceptable and should be assessed in future research.     

美国FDA“动物（效应）法规”在生物防御药物开发中的应用及启示

目的： 在应对重大公共卫生事件中，为我国相关生物防御药物的上市审批和应用储备提供参考依据和解决思路。方法： 结合审批实例，对美国FDA"动物（效应）法规"的主要内容、应用范围和实施状况进行综述，针对美国和我国现阶段应对重大公共卫生事件的药品审批机制进行讨论。结果与结论： 在针对可能发生的生物恐怖袭击事件及重大疫情开展的药物研发中，评价尺度可以与普通药物有所区别，应视情做好相应生物防御药物的战略储备，为应对突发重大公共卫生事件提供系统性支持。     

Arguments supporting and opposing legalization of safe consumption sites in the U.S.

BackgroundSafe consumption sites are spaces where people can legally use pre-obtained drugs under medical supervision and are currently in operation in Canada, Australia and Western Europe. These sites are effective in reducing opioid overdose mortality and other harms associated with opioid use, such as HIV infection, and increasing drug treatment entry. Various U.S. communities are considering establishing safe consumption sites, however, only 29% of U.S. adults support their legalization. This purpose of this study is to assess what types of arguments resonate with the public in support of and opposition to legalizing safe consumption sites to combat the opioid epidemic.MethodsA public opinion survey of U.S. adults in July-August 2017 (N = 1004) used a probability-based sample of respondents from a large, nationally representative online panel. The survey examined the public’s perception of the strength of common arguments offered in support of and opposition to legalizing safe consumption sites. Arguments were identified through a detailed scan of news media coverage, public reports, and advocacy materials.ResultsThe national sample of U.S. adults rated all arguments opposing legalization of safe consumption sites as stronger than any of the arguments supporting legalization. The most highly rated opposing arguments were that public funds were better spent on addiction treatment, and that sites were allowing illegal activity and encouraging people to use drugs. The highest rated arguments supporting legalization were that safe consumption sites were a better alternative than arresting people for using drugs, they would reduce HIV and hepatitis C by encouraging safe injection practices, and that they would lower emergency department admission and hospitalization costs.ConclusionLegalization of this evidence-based harm reduction approach in U.S. communities will be difficult to advance without public education to confront persistent myths that safe consumption sites encourage drug use and do not facilitate treatment access.     

Public drug use in eight U.S. cities: Health risks and other factors associated with place of drug use

BackgroundDrug overdose is the leading cause of accidental death in the United States (U.S.). Previous studies have found that place of drug use is associated with risks including overdose, sharing of drug use equipment, and arrest, but the research on this subject in the U.S. is limited.MethodsOur study describes the relationship between place of drug use and health outcomes through the analysis of associations between frequent public drug use and drug-related arrest, overdose, and reuse of injection equipment. We analysed data from a cross-sectional, observational study of individuals who utilize syringe exchange services in 8 U.S. cities. Using regression analysis, we assessed associations between public drug use, demographic characteristics, and health risks.ResultsHalf (48%) of the respondents (N = 575) reported that at least one of their top two most frequent places of drug use is a public place. Street homelessness (AOR = 17.44), unstable housing (AOR = 3.43) and being under age 30 (AOR = 1.85) were independently associated with increased odds of frequent public drug use. Frequent public drug use was associated with increased odds of past-year arrest for drug-related offenses (AOR = 1.87).ConclusionPublic drug use is associated with negative health and social outcomes. Increased access to harm reduction services, housing, and supervised consumption sites (SCS) interventions and a shift away from punitive approaches to drug use may reduce the some of the harms associated with public drug use.     

Personalizing public health: Your health avatar

ObjectivesTo describe the creation of a health avatar, with the goals of providing patients with complete health information from various sources, establishing an interactive and customizable platform, empowering users to determine how the health information best fits or speaks to their personal needs, and providing perspective by comparing the health status of the individual with that of the individual's community.SummaryThe Internet is rapidly becoming integrated into Americans' daily lives. According to the 2007 Health Information National Trends Study, 69% of U.S. adults had access to the Internet and 23% reported using a social networking site. The impact of social media has further grown, and an estimated 50% of adults in America have a profile on social media. The potential for using cyber communities to improve health messaging is great. Several health care organizations have implemented the use of social media in a variety of ways to varying degrees of success. We propose a platform that automatically gathers information and reflects the health status of an individual back to the user. An avatar, which is a representation of a user, could be created and assigned characteristics that allow users to appreciate their health status. The health avatar platform also would allow users to compare their personal status with that of their community. The overall goal is to engage and then motivate users to improve their overall health status.ConclusionMedicine must acknowledge the evolving relationships that the next generation of patients will have with technology. The health avatar is a platform that incorporates a connection with the health system through electronic medical records and connects individuals to the greater community.     

Cross-border paid plasma donation among injection drug users in two Mexico–U.S. border cities

ObjectivePaid plasma donation has contributed to HIV epidemics in many countries. Eleven million liters of plasma are fractionated annually in the U.S., mainly from paid donors. Deferral of high-risk donors such as injection drug users (IDUs) is required for paid donations. We studied circumstances surrounding paid plasma donation among IDUs in two Mexico–U.S. border cities.MethodsIn 2005, IDUs ≥18 years old in Tijuana (N = 222) and Cd. Juarez (N = 206) who injected in the last month were recruited through respondent-driven sampling. Subjects underwent antibody testing for HIV and HCV and an interviewer-administered survey including questions on donating and selling whole blood and plasma.ResultsOf 428 IDUs, HIV and HCV prevalence were 3% and 96%, respectively; 75 (17.5%) reported ever having donated/sold their blood or plasma, of whom 28 (37%) had sold their plasma for an average of $16 USD. The majority of IDUs selling plasma were residents of Ciudad Juarez (82%); 93% had sold their plasma only in the U.S. The last time they sold their plasma, 65% of IDUs had been asked if they injected drugs. Although the median time since last selling plasma was 13 years ago, 3 had done so within the prior 2 years, one within the prior 6 months; of these 3 IDUs, 2 were from Cd. Juarez, one from Tijuana; all 3 had only sold their plasma in the U.S.ConclusionsAlthough selling plasma appears uncommon among IDUs in these two Mexican border cities, the majority sold plasma in the U.S. and only one-third were deferred as high-risk donors. Paying donors for plasma should be a matter of public inquiry to encourage strict compliance with regulations. Plasma clinics should defer donors not only on behavioral risks, but should specifically inspect for injection stigmata.     

Timothy Leary,Richard Alpert (Ram Dass) and the changing definition of psilocybin

BackgroundThis research focuses on the events leading to the 1968 U.S. federal prohibition of psilocybin. It is a study of duelling moral entrepreneurs—Timothy Leary and Richard Alpert vs. the Harvard University Administration. The goal is to show how the primary active compound in an ostensibly harmless fungus (the psilocybin mushroom) became controversial in less than a decade.MethodsWe used books, newspapers, magazine articles and previously unpublished materials (including documents from the Harvard Archives) to analyze Leary and Alpert's lives and careers through the early 1970s.ResultsThe prohibition of psilocybin in the U.S. was largely a product of Leary and Alpert's involvement in the “Harvard drug scandal” and their transformation from Harvard professors to countercultural icons. They tested the substance on a variety of human subjects and in doing so piqued the interest of Harvard undergraduates while drawing condemnation from other faculty and Harvard administrators. This case is theoretically interesting because unlike most illegal drugs, psilocybin was never linked to a threatening minority group, but to some of the nation's most privileged youth.ConclusionThe Harvard administrators were not really moral entrepreneurs but Leary and Alpert clearly were. Although they were far from being prohibitionists, they were self-righteous crusaders on different but equally holy missions for the good of young and minority Americans. Ironically, due to their successes the possession of psilocybin was criminalized under United States federal law in 1968 (Pub. L. No. 90-639, Stat. 1361 1968 and Boire, 2002). This case study demonstrates that crusaders can be successful in changing culture even when laws are passed in futile attempts to control their behaviour, just as Leary predicted.     

Transformational strategies for optimizing use of medications and related therapies through us pharmacists and pharmacies: Findings from a national study

SettingNonoptimized medication therapies (NOMTs) are associated with likely avoidable illnesses and mortality affecting millions of people and costing an estimated $528 billion per year in excess health spending in the United States. The coronavirus disease 2019 (COVID-19) pandemic brought into focus barriers limiting the ability of U.S. pharmacists and pharmacies to provide services that can reduce NOMTs and improve U.S. population health.ObjectivesThis National Science Foundation Center for Health Organization Transformation study explored potential strategies that U.S. pharmacists, pharmacies, and their partners could implement to reduce NOMTs while also delivering other forms of value to U.S. populations from 2021 to 2025 (during and after the COVID-19 pandemic).DesignA panel of senior leaders representing the U.S. pharmacist and pharmacy sector participated in a 4-round Delphi process to identify unmet needs, barriers, change drivers, and priority strategies for meeting those needs. Data were gathered and analyzed by public health researchers, most of whom are outside the pharmacist and pharmacy sector.ResultsA comprehensive set of evidence-based strategies with potential to reduce NOMTs, protect and improve population health and well-being, and strengthen the sector were identified. Four transformational strategies were recommended: comprehensive payment and practice transformation, strengthening pharmacy data interoperability infrastructure, development of unifying measurement and management mechanisms, and development of a more robust national research infrastructure. Strengthening health equity was a cross-cutting strategy affecting all areas.ConclusionThe results may be of interest to policy makers, pharmacists, pharmacies, physicians, nurses and other clinicians, pharmaceutical firms, plan sponsors, plans, health systems, clinics, aging care, digital technology companies, and others interested in optimizing outcomes from medications and related therapies for U.S. populations.