美国医药产品紧急使用授权风险管理研究

摘要：目的:研究美国医药产品紧急使用授权法规及指南,梳理对紧急使用授权产品监管措施,探讨建立适合我国国情的医药产品紧急使用授权制度。方法:查阅美国食品药品管理局官方网站及国内外文献数据库,分析美国医药产品紧急使用授权制度及实践经验。结果:美国医药产品紧急使用授权需要进行申请、审评、授权、定期收集安全性信息、持续风险效益评价等风险管理措施。结论:紧急使用授权制度对于加强公共卫生事件应对能力至关重要,我国应建立医药产品紧急使用授权制度,全面提升药械审评与评价能力及时发现授权产品风险,同时重视紧急使用授权产品的信息公开。     

美国FDA医疗产品紧急使用授权管理简介及启示

介绍了美国医疗产品紧急使用授权的定义,法律依据、管理程序和判定标准,以及执行过程中具体操作条件和要求。以期对我国相关管理机构在公众健康安全紧急状态下,对医疗产品的紧急使用授权管理提供借鉴。     

建立我国突发事件应急状态下的医疗产品紧急使用授权机制探讨

目的： 通过对美国FDA的紧急使用授权（Emergency Use Authorization,EUA）制度进行研究,结合我国国情,探讨在我国建立医疗产品紧急使用授权机制。方法： 文献研究、专题访谈。结果与结论： 紧急使用授权制度有别于我国现有的特别审评程序,对于应对突发事件应急状态下所需药物的评估和使用授权,提高药物使用的安全性、时效性、可及性及合规性具有重要意义。本研究初步提出了在我国建立医疗产品紧急使用授权机制的考虑要点,包括建立紧急使用授权制度的必要性、制度的基本定位、上位法的支持、制度构建的关键要素、配套的技术指南及其他需要关注的问题。     

新型冠状病毒肺炎疫情应对视角下建立药械紧急授权使用制度研究

从新型冠状病毒肺炎疫情爆发后药械紧急研发和审批的迫切需求为切入点,分析我国药械特别审批制度存在的问题,指出紧急授权使用制度缺乏上位法依据,应当建立超越常规上市许可的紧急授权使用路径,建议在《药品管理法实施条例》《医疗器械监督管理条例》中引入紧急授权使用条款.由国务院药品监督管理部门制定《药品紧急授权管理办法》《医疗器械紧急授权管理办法》,对紧急授权的产品范围、审评部门、审评程序、申请资料、责任豁免等作出规定.     

甲型H1N1流感简介

甲型H1N1流感是一种新型流感病毒,且能够传染人,通过呼吸道传播,临床主要表现为流感样症状,多数患者症状比较轻。病毒对奥司他韦和扎那米韦敏感,早发现、早诊断是防控与治疗的关键。     

我国药品紧急使用的制度问题及对策建议

目的 为我国药品紧急使用授权制度的建立提供政策建议.方法 采用文献调研法系统梳理我国在新型冠状病毒肺炎(简称新冠肺炎)疫情中使用未上市药品或超药品说明书用药应遵循的法律依据;采用专家咨询法分析我国现有法律法规在应对该类情况时存在的不足;借鉴美国经验,提出完善我国相关制度的建议.结果与结论 我国在新冠肺炎疫情期间使用未上...     

海南州首例甲型H1N1流感病例的发现与处置

<正>2009年3月在墨西哥等国家发生的甲型H1N1流感疫情蔓延迅速,已成为全球高度关注的重大公共卫生事件。6月11日世界卫生组织将这次流感流行的警告级别提高到6级[1],2009年5月10日,四川省报告1例甲型H1N1流感疑似病例,被国家确诊为中国内地首例甲型H1N1流感病例[2],2009年9月5日青海省首次确诊为甲型H1N1流感病例[3],2009年9月24日,海南州首次确诊为甲型H1N1流感病例。     

大流行流感与甲型H1N1流感

目的对大流行流感和甲型H1N1进行综述。方法参考国内外近期的有关文献和WHO的相关报道,介绍了流感病毒的基本知识、大流行流感的定义和发展,以及甲型H1N1流感的特点和流行现状等。结果与结论大流行流感具有传播性强、危害大等特点,2009年的甲型H1N1流感为21世纪的第1次大流感,应加以重视。     

美国FDA在应急医药产品应急准备中的职能分析

目的:对美国流行病和灾害性应急准备系列法案中美国食品药品监督管理局(FDA)职能定位进行分析,为我国政府部门的应急职能设计提供参考。方法:采取法案内容分析法,了解FDA在应急医药产品准备中的职能定位。结果:FDA在医药产品应急准备的根本职能是促进突发事件中应急医药产品的开发和使用的可获得性,包括发布医药产品的应急指导和安全警示信息,负责授权医药产品紧急使用权、延长医药产品保存期限及预置职能。结论:应重视国家级应急准备工作,完善应急准备的配套法律体系,准确定位"应急医药产品的应急预案",加强应急医药产品的应急信息化管理,建设应急医药产品的快速调剂和使用机制。     

浅议甲型H1N1流感患者的护理

目的探讨甲型H1N1流感（甲流）患者的护理方法。方法主要是基础护理,心理护理和发热患者的护理。结果患者无一例交叉感染,体温均降至正常。结论通过上述的护理方法的实施,24例患者均痊愈出院,无一例出现并发症、后遗症。     

The modification of natural products for medical use

Drug innovation is characterized by painstaking molecular-level syntheses and modifications as the basic components of research and development. Similarly, natural products are chemically tailored and modified based upon their structural and biological properties. To some extent, the modification of natural products is quite different from de novo structure-based drug discovery. This review describes the general strategies and principles for the modification of natural products to drugs, as illustrated by several successful medicines that originated from natural products.     

Regulatory analysis on the medical use of ephedrine-related products in Taiwan

To prevent ephedrine-related products from being misused to produce amphetamine and/or its analogs, there's a need for more effective and achievable regulatory mechanisms for the health, police, investigational, prosecution and judiciary authorities in Taiwan. This review was conducted to evaluate the international and Taiwan's regulatory policies and management of medical ephedrine-related products through the corresponding information collected from international and Taiwan government agency authorities. The combat of illegal drugs should involve both supply and demand sides to be successful. Health authorities in Taiwan do not have the investigational power to manage the forbidden transformation, abusing and manufacture of the illegal drugs from ephedrine-related products. Take the judicial interventions in the United States and in Japan as the examples, the organizational cooperation in Taiwan can be one of the main key strategies to combat against illegal drugs from ephedrine-related products. It is necessary to integrate the judicial, police and health agencies to prevent the production of illegal drugs from the ephedrine-related products in Taiwan. The efforts and regulatory control measures should be integrated to speed up the collaboration between different government authorities. It might be achieved through reorganization involving Taiwan Food and Drug Administration.     

Typical pitfalls in applications for marketing authorization of biotechnological products in Europe

Although regulatory standards and procedures in Europe have improved following the establishment of the European Medicines Agency (EMEA), the number of major issues with marketing authorization applications for biotechnological products remains high. For example, the pivotal clinical trials of some late-stage failures have been found not to meet the regulatory guidelines of the European Union, and regulators are increasingly concerned that attempts to accelerate the process of biotechnological product development leads to the neglect of important issues. Based on the scientific decisions of the EMEA's major scientific committees, in this article we identify and discuss frequent concerns, and suggest approaches that might enable developers of biotechnological products to avoid these common pitfalls.     

我国医疗器械注册人制度试点实施的风险分析及策略探讨

目的为我国医疗器械注册人制度全面落地实施提供参考建议。方法通过对江苏省医疗器械注册人制度试点实施研究工作进行调研,分析该制度试行过程中可能存在的风险,并就应对策略进行探讨。结果该制度实施后可能存在多种风险,主要来源有注册人质量责任承担能力不足、注册人全生命周期风险管理能力欠缺、知识产权保护与委托生产难以平衡、受托生产企业落实生产责任不到位、跨区域委托生产监管难度增加等。结论建议应设立对注册人的资格准入条件,提高注册人的全生命周期风险管理能力,强化医疗器械知识产权保护意识,加强对受托生产企业的监督管理,建立跨区域协同合作的监管机制。     

FDA对注射药品包装类型术语的新要求

美国食品药品管理局（FDA）于2015年12月发布了“多剂量、单剂量和单一患者用容器包装的人用注射药品的合适包装类型术语的选择和标识建议行业指导原则（草案）”,该指导原则明确了人用注射药品的包装类型术语的定义,并对药品说明书和包装标签上如何进行标识提供了相应建议,以保证使用者很容易识别包装类型,进而保障用药安全。我国目前尚无这类指导原则,介绍该指导原则的主要内容,以期对我国制药企业严谨而合理使用注射药品的包装类型术语和药品监管部门加强这方面的管理有所帮助。     

Disregarded use of herbal medical products and dietary supplements among surgical and medical patients as estimated by home inspection and interview

PURPOSE: More and more patients use herbal medical products (HMP) and dietary supplements (DS). Due to the possibility of drug interactions and side effects, it is important that physicians are aware of the use. The aim of the present cross sectional survey was to analyse the consumption of HMP and DS among patients recently discharged from two hospital departments. METHODS: Patients were visited within 1 week after discharge and interviewed about their use of HMP and DS. Stored products were inspected and registered. Hospital files and discharge letters were examined to establish the frequency of registration. RESULTS: Totally, 83 surgical and 117 medical patients were included (n = 200), 139 patients (70%) were women. 53 patients (27%) stored no HMP or DS, whereas the home inventories of 147 patients (74%) comprised 343 products. 116 patients (58%) used HMP or DS daily and 25 patients (13%) used the products on demand. The most frequently used product was multivitamins (82 patients = 41%). Totally, 61% of the products were used on the patients' own initiative. In 3% of the used products, patients were aware of possible side effects. No patients were aware of possible drug interactions. Only 21% of the 211 HMP and DS used daily prior to admission were recorded in the hospital files. CONCLUSIONS: The use of HMP and DS was frequent among surgical and medical patients. The use was often not recorded in the hospital files and patients' knowledge of possible side effects and drug-interactions was minimal.     

Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use

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创伤性失血性休克的急诊救治

目的:探讨创伤性失血性休克的急诊急救方法,提高急诊急救水平.方法:回顾性分析3 126例创伤性失血性休克患者的急诊救治资料.结果:本组好转2 626例,占84.1%;无变化219例,占6.0%;死亡155例,占5.01%;恶化158例,占5.2%.结论:制订有效的抢救方案及合理早期抗休克治疗是急诊救治的关键.