共查询到20条相似文献,搜索用时 296 毫秒
1.
《中国药房》2017,(10):1302-1306
目的:研究美国生物制品数据保护制度立法演变与成因,为我国生物制品数据保护制度设计提供参考。方法:从梳理美国生物制品数据保护特点出发,通过剖析美国生物制品数据保护制度的立法斗争,挖掘这一制度的形成过程和原因及对我国的启示。结果与结论:经过立法的探讨、演变与斗争后,美国于2010年颁布《生物制品价格竞争与创新法案》,确立了全球首个"强保护"标准的生物制品数据保护制度并确定12年的数据保护期;这一制度的立法基础是激励创新的战略需求,直接原因是美国建立了生物类似物简化申请途径,重要因素包括生物制品技术属性与专利保护特点。但我国现阶段暂不适合建立生物制品数据保护制度,未来在国情相匹配或者战略选择需要时,亦应按照由无到有、由弱到强的路径来实施该制度。同时,成熟的注册审批体系是建立数据保护制度的基础。 相似文献
2.
3.
生物制品数据保护已成为药品数据保护制度的新发展方向,我国面临制度建设的问题。不同于国际主流模式,日本生物制品数据保护制度融合于新药再审查制度中,强化新药安全监控之目的。本文对日本生物制品数据保护的制度沿革、保护对象与期限、保护方式等核心机制进行了系统梳理,并通过英夫利昔单抗案例开展了深入的实证分析,为我国生物制品数据保护制度的探索和建设提供借鉴。 相似文献
4.
5.
6.
《中国新药与临床杂志》2015,(8)
本文以辉瑞公司抗抑郁药舍曲林在日本的数据保护过程为研究对象,采用典型案例实证分析法,分析日本药品数据保护制度的安全监控机制。通过分析数据保护制度与上市后风险管理制度的配套实施过程,探讨数据保护制度的创新药物安全监控效应,以期为完善我国药品数据保护制度提供借鉴。 相似文献
7.
8.
9.
目的:分析中国、美国、欧盟新生物制品的专利与数据保护协同效果,结合我国国情为专利期补偿和数据保护制度完善提供参考。方法:收集2015—2021年中国、美国、欧盟获批上市的新生物制品及专利和数据保护期以评估保护效果差异。结果:2015—2021年中国(含1类和3类进口原研)、美国、欧盟分别批准新生物制品70,88和98个。仅考虑专利保护时,中国3类进口原研的平均有效专利期显著低于美国、欧盟水平。模拟专利与数据保护叠加时,假设1类和3类进口原研均可获得补偿,数据保护期为12年时平均独占期与美欧相当。结论:按照国民待遇原则1类和3类进口原研药均应纳入专利补偿范围;考虑专利保护与数据保护的叠加效果,对治疗用生物制品采取9-12年的数据保护期设计,可以与美国、欧盟的治疗用生物制品保护效果相当。 相似文献
10.
11.
12.
13.
14.
15.
16.
关于药品试验数据以什么方式保护存在争议.《与贸易有关的知识产权协定》(TRIPS协定)第39条第3款规定了药品试验数据的反不正当竞争保护模式及其例外情形.我国采取的是与美国等发达国家相同的数据独占保护模式,高于TRIPS协定的保护标准.2018年,国家药品监督管理局公布的《药品试验数据保护实施办法(暂行)(征求意见稿)... 相似文献
17.
18.
本文构建了基于熵权法的评价指标体系,以2009-2012年的面板数据为基础,对我国医药产业的技术创新能力进行量化,比较化学药品制造业、中成药制造业、生物生化制品制造业、医疗设备及器械制造业技术创新能力的差异性,分析影响各行业技术创新能力的因素。结果表明:化学药品制造业的技术创新能力最强,中成药制造业最弱,生物生化制品制造业、医疗设备及器械制造业居中;我国医药产业的技术创新能力受到多种因素的影响,且各行业的主要影响因素存在显著差异。在此研究结果的基础上提出了提升医药产业技术创新能力的对策建议。 相似文献
19.
Youngstrom E Kenworthy L Lipkin PH Goodman M Squibb K Mattison DR Anthony LG Makris SL Bale AS Raffaele KC LaKind JS 《Neurotoxicology and teratology》2011,33(3):354-359
The ability to conduct weight-of-evidence assessments to inform the evaluation of potential environmental neurotoxicants is limited by lack of comparability of study methods, data analysis, and reporting. There is a need to establish consensus guidelines for conducting, analyzing, and reporting neurodevelopmental environmental epidemiologic studies, while recognizing that consistency is likewise needed for epidemiology studies examining other health outcomes. This paper proposes a set of considerations to be used by the scientific community at-large as a tool for systematically evaluating the quality of proposed and/or published studies in terms of their value for weight-of-evidence assessments. Particular emphasis is placed on evaluating factors influencing the risk of incorrect conclusions at the level of study findings. The proposed considerations are the first step in what must be a larger consensus-based process and can serve to catalyze such a discussion. Achieving consensus in these types of endeavors is difficult; however, opportunities exist for further interdisciplinary discussion, collaboration, and research that will help realize this goal. Broad acceptance and application of such an approach can facilitate the expanded use of environmental epidemiology studies of potential neurodevelopmental toxicants in the protection of public health, and specifically children's health. 相似文献
20.
《Expert opinion on therapeutic targets》2013,17(2):167-178
Introduction: The sirtuin SIRT1 is expressed throughout the body, has broad biological effects and can significantly affect both cellular survival and longevity during acute and long-term injuries, which involve both oxidative stress and cell metabolism. Areas covered: SIRT1 has an intricate role in the pathology, progression, and treatment of several disease entities, including neurodegenerative disorders such as Alzheimer's disease and Parkinson's disease, tumorigenesis, cardiovascular disease with myocardial injury and atherosclerosis, metabolic disease, and aging-related disease. New areas of study in these disciplines, with discussion of the cellular biology, are highlighted. Expert opinion: Novel signaling pathways for SIRT1, which can be targeted to enhance cellular protection and potentially extend lifespan, continue to emerge. Investigations that can further determine the intracellular signaling, trafficking and post-translational modifications that occur with SIRT1 in a variety of cell systems and environments will allow us to further translate this knowledge into effective therapeutic strategies that will be applicable to multiple systems of the body. 相似文献