药品分类管理的现状分析和面临的挑战

建立药品分类管理体制是与国际先进医药管理模式接轨的触点 ,是历史的进步和必然进程。它必将对我国的医药科研、生产、药品经营等各个环节产生重大的影响。面对潜力巨大的非处方药 (OTC)市场 ,如何抓住机遇、营造有利于自身生存和发展的空间 ,是医院药房和零售商店面对的新课题。本文将 OTC制度对我国有关领域产生的影响进行探讨。1　非处方药市场前景繁荣1 .1　 OTC的市场发展和优势　对处方药和非处方药实行分类管理 ,是国际通用的药品管理方法。美国是于 1 951年首先创建OTC制度的国家 ,之后在日本、英国、德国和加拿大也相继建立…     

阿里成功赴美上市

2014年9月19日晚,阿里巴巴赴美上市,并最终创造美股史上最大IPO。 @邓学文博士说股市期市：阿里巴巴的赴美上市,必将对中国证券市场的机制改革产生积极影响。美国金融界人士认为,“因为缺乏国内的融资渠道,企业才去国外融资,有了外国资本,就不能在国内上市,从而丧失了很多新机会。这是赴美后,阿里巴巴在‘纽交所大捷’应该带给中国市场的一些冷思考”。     

诌议非处方药与医院执业药师

随着医药卫生事业改革的深入进行和我国加入世界贸易组织(WTO)及世界卫生组织(WHO)后,为了与国际医疗药品管理模式的接轨,实行处方药与非处方药的分类管理制度是十分关键的步骤.这一制度的实施,将对我国医药单位的药品生产、销售、管理、使用等产生深远的影响,必将促进整个卫生保健事业向更高层次的发展.     

药品分类管理对药店的影响

我国于2000年1月1日起正式实施了处方药与非处方药分类管理制度.这是建国50年来我国对药品监督管理工作的又一重大改革.这无疑是中国药店与国际接轨迈出了可喜一步.随着两批非处方药目录的公布和相关政策法规的出台,对医药工业、商业企业都将产生重大的影响,本文就药品分类管理对药品零售业即将产生的影响作浅述.     

市场观察

医药市场发展走势分析企业面临新的机遇和挑战 2005年是我国医药流通体制改革继续纵深发展的一年。企业一方面面临加入WTO 后,国外资本和企业进入我国药品分销市场与之竞争;我国医药分销企业规模小,产业集中度低,国际竞争力弱,在规模、资本、网络、业态、效率、管理、营销手段等方面将受到来自国际跨国公司的挑战:另一方面,“三项制度”改革的进一步深化,药品集中招标采购将在进一步规范完善中持续开展下去;药品价格更趋市场化;后 GSP     

审评审批制度改革背景下医药产业组织结构调整路径研究

药品审评审批制度改革，是国务院"放管服""双随机一公开"政策在医药产业研发领域的重大举措。2015年以来，药品审评审批制度改革对中国医药产业组织结构产生了一定影响。基于审评审批制度与政府组织结构、医药组织结构调整的分析，本文采用Panel Data模型对研发创新组织结构相关影响因素进行实证分析。实证分析结果显示了科技孵化器、境内技术转让、技术转移宏观环境对企业临床试验申报行为呈显著性正相关。基于审评审批制度的医药产业组织结构调整路径，包括专业化分工、大数据模式、国际合作、MAH制度和科技金融模式。     

卫生体制改革的目标与政策选择--国际卫生体制改革的经验与教训

引入市场机制,采取分权、分级与分类管理等政策与措施是当今国际卫生体制改革中的主流特点,由于各个国家的社会经济体制与卫生保健制度不同,这些改革政策与措施所产生的影响与效果也各具特色.因此,在深化我国卫生体制改革的进程中,借鉴国际卫生体制改革的经验与教训具有一定的现实意义.     

《关于化学品注册评估批准和限制制度》给 中国医药工业带来的机遇与挑战

［摘要］针对《关于化学品注册、评估、批准和限制制度》 (REACH)涉及医药产品的条款进行分析，并从药品生产、研发、包装和医药行业整体环境等角度分析法规所带来的影响。REACH法规将对中国医药工业产生巨大影响，同时也带来了机遇和挑战。中国药品生产企业和相关政府机构应该给予足够的重视，抓住机遇不断提高国际竞争力。     

我国推行非处方药制度进展及政策取向简析

在我国推行处方药与非处方药分类管理制度,业已列入国家有关部门的重要议事日程,并正有计划地逐步推进。笔者认为,这是医药与卫生事业深化改革的一个重大举措,是与国际卫生工作与药品管理模式接轨的关键,也是创建文明行业、加强药品管理的实际需要。因此,可以预计,这一制度的实施,必将对我国医疗单位及药品生产流通领域形成有力的撞击,产生深远的影响。当然,这些撞击与影响,对医药和卫生事业的进步与发展是有利的,也是不可缺少和     

整合进行时

在2007年的各种行业变化中，零售板块的整合趋势逐渐显露。在政策、市场、资本等因素的引导下，整合是企业自我调整的一种新的方式。“整合风”所到之处，对内是企业自身的改变，对外则会对市场格局产生影响。     

Illegal drug markets in transitional economies

The rise of illegal drug markets in transitional economies is usually conceptualized as an effect of economic transition. With the emergence of new understandings of transitional economies and contemporary thinking about global capitalism, drug markets can be understood to have a different function. In global capitalism, the illegal drug market is an apparatus of capture that choreographs a quest for pleasure, liberation, freedom and the hope for consumption promised by global media. Capitalism thrives on its own incorporative processes such that the limitative becomes constitutive. Global capitalism is defined by the dissolution of limitative boundaries such as sovereign borders, sovereign bodies, sovereign ethnic groups, and the subsequent deformation/reformation of the very boundaries to commodity markets. Illegal drug markets mediate this function through capturing bodies, markets, dreams of freedom, and the social order and subsuming them to productive capital. In transitional economies, the illegal drug market is both an effect of transition and a cause. Illegal drug markets create the possibilities for a market economy based on the capture and mobilization of affects; the introduction of new forms of consumption, and the redirection of flows of capital in an environment where capital flows are malleable and labour markets are easily re-defined. Rather than being parasitic, the modern illegal drug market is constitutive of modern liberal democracies emerging from transitional economies. The roles of harm reduction organizations are discussed in light of this theory.     

我国中药进入国际市场的问题研究

目的:为将中药推向国际市场提供具有操作性的思路和方法。方法:对我国中药进入国际市场的有利条件和不利因素进行广泛深入的调查和对比分析。结果与结论:我国应加强对中药的生产和质量管理;重视并研究各国关于中草药产品的法律法规,结合我国产品的条件和特点,找准国际市场定位,有的放矢;有关方面应集中力量,加强中药研发,并借助中医的推广进入国际市场。     

Reimbursement for new health technologies. Breakthrough pharmaceuticals as a 20th century challenge

The regulation of pricing and trade for in-patent medicines within the European pharmaceutical sector presents a major challenge. In conditions of large sunk costs and consumers with differential willingness to pay--between different Member States--an efficient way of pricing in-patent medicines is through price discrimination, by which more is charged in markets that can bear it and re-exports are prevented from undercutting this strategy. Parallel trade and the use of international price comparisons by government regulators can result in pressure for price convergence with consequent delays in launching products in certain markets. Imposing free movement of pharmaceuticals may particularly harm patients in lower income Member States, who may find pharmaceuticals more expensive or unavailable. Data on first consumption of important new pharmaceuticals show long delays for patients in certain Member States.     

Change is possible: the history of the international drug control regime and implications for future policymaking

The article, based upon an extensive literature review, reconstructs and analyzes the parallel evolution of the international drug control regime and the world opiate market, assessing the impact of the former on the latter until the rise of present-day mass markets. It shows that, since its inception, the regime has focused almost entirely on matters of supply. However, that focus has not always meant "prohibition"; until 1961, the key principle of the regime was "regulation." Given the different forms drug control policy has taken in the past, the authors conclude it may be amenable to new forms in the future.     

Change is Possible: The History of the International Drug Control Regime and Implications for Future Policymaking

The article, based upon an extensive literature review, reconstructs and analyzes the parallel evolution of the international drug control regime and the world opiate market, assessing the impact of the former on the latter until the rise of present-day mass markets. It shows that, since its inception, the regime has focused almost entirely on matters of supply. However, that focus has not always meant “prohibition”; until 1961, the key principle of the regime was “regulation.” Given the different forms drug control policy has taken in the past, the authors conclude it may be amenable to new forms in the future.     

止吐药研发现状及发展趋势

通过查询CFDA、FDA数据库,汇总分析国内外已上市止吐药的种类、生产批件数量、销售金额以及近3年产品注册申报情况,发现国内止吐药生产批件众多,且有不少企业仍在仿制,临床用药高度集中于5-HT3受体拮抗剂类品种,其销售金额占据止吐药98%的市场份额,市场呈平稳增长态势。然而,近年来随着新作用机理的NK-1受体拮抗剂类止吐药成功上市,止吐药市场格局将迎来新的变化,也给企业带来了新的机遇和挑战。因此,企业在抢夺市场先机之时应注意防范过度仿制带来的产品风险。     

我国中药出口的现状及对策

本文介绍了我国中药出口的现状 :我国中药出口额占工业总产值比例较低 ,规模偏小 ,产品结构不合理 ,市场集中度较高 ,出口过度依赖日韩等亚洲市场 ;我们认为导致中药出口困难的深层次原因在于一系列壁垒的限制 ,包括“文化壁垒”、“技术壁垒”、“信息壁垒”以及中药现代化水平 ,因此应采取措施加强中医药文化交流与战略合作 ,实施中药标准化 ,建立信息沟通及保障机制以及进行科技创新、加速中药现代化进程     

USP认证对我国原料药企业的影响分析

目的为我国原料药出口企业提供一条更为适用的国际认证途径。方法采用比较分析方法,阐明USP认证不同于其他几种较为成熟的国际认证方式的特性。结果与结论USP作为一种新的认证方式,从适用范围、认证流程、认证速度、认证费用以及认证周期等方面更适合中国原料药企业的发展现状,对我国企业开拓国际市场意义重大。     

从2000年上市公司中报看医药行业现状及发展趋势

在沪深两地证券交易所挂牌上市的医药类公司,在全国医药行业中,具有很强的代表性。本文通过这些公司2000年中期报告的研判,分析当前医药行业的现状和发展趋势。     

The regulation project: Tools for engaging the public in the legal regulation of drugs

Lack of legal regulation and oversight of scheduled drugs in Canada has led to an unsafe drug supply responsible for the deaths of tens of thousands. In addition to contributing to the worst unregulated drug poisoning crisis in Canada's history, the policy framework prohibiting non-medical access to certain drugs has exacerbated numerous public health and safety concerns. An alternative approach to prohibition is for government to retake control of the currently illegal drug market through legal regulatory mechanisms. This paper presents the work of an ongoing international collaboration of organizations advocating legal regulation and some of the knowledge translation tools used to educate and engage the public on legal regulation within Canada. In order to encourage thinking and decision-making among stakeholders in a productive way, models of legal regulation for various substances were created as discussion tools to emerge values and considerations supporting different approaches. The models focus on five questions: 1) who has access to drugs; 2) how access is obtained; 3) where drugs can be accessed; 4) how much people can obtain; and 5) where drugs can be consumed. The models were presented to stakeholders in the context of an international meeting on legal regulation, and then adapted to a more “user-friendly” form: a collaborative negotiation-based Regulation Game, which was presented at a workshop in Montréal, Canada. Engaging different stakeholder groups on policy choices of legal regulation revealed initial barriers that we feel more confident can be overcome through creative and innovative tools such as the Regulation Game. Use of the game as a foundation for more traditional focus groups could be effective in reducing barriers to fulsome policy discussions on legal regulation.