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论文编号：	7976
作者编号：	2120132817
上传时间：	2015/12/9 13:38:51
中文题目：	中药注册欧盟传统植物药项目风险管理研究
英文题目：	Study of Risk Management on Chinese Medicine Registration for EU Traditional Herbal Medicine Project
指导老师：	石鉴
中文关键字：	中药，欧盟传统植物药，风险管理
英文关键字：	Chinese Medicine; EU Traditional Herbal Medicine; Risk Management;
中文摘要：	摘 要 欧盟作为全球最大的植物药市场之一，市场规模约250亿美元，但我国中药对欧盟地区的出口，由于受到欧盟2004年颁布《传统植物药注册程序指令》的影响，自2011年4月30日开始，未通过注册的植物药不能以药品的名义在欧盟地区销售，而只能以保健品或食物添加剂的身份进行流通，且严格限定不允许标注适应症和疗效。据统计，在该法令期限之前申请并通过的1000多例传统植物药中并没有一家中国企业产品的身影。这直接造成了自2011年起，中国出口欧盟地区的中成药销售额的大幅度下降。然而随着2012年3月14日，成都地奥制药集团研制生产的“地奥心血康胶囊”获得了荷兰药监局的传统植物药上市批准，成为我国第一例在欧盟获得药品身份的中药产品。更多的中药企业发现，欧盟的注册申请规定并非高不可攀，我国政府也提出鼓励中药企业通过提升质量标准，通过中药创新和提升制造工艺，更好的宣传中医中药文化的政策在这样的背景下，越来越多的中药企业开始选择适合自身的中药品种，开展注册欧盟传统植物药项目，一方面开阔自己的海外市场，一方面提升自己的品牌价值。 然而，中药注册欧盟传统植物药项目具有很高的项目复杂性和困难，企业开展此类项目投入成本高，项目周期长，不确定性高，存在较大的风险性。本研究通过分析我国中药企业的进行注册欧盟传统植物药项目的现状和困难，从项目管理的角度，通过应用项目管理理论中的风险管理知识，分析针对中药注册欧盟传统植物药项目的特点，从技术、市场、政策和管理几个方面，如何进行风险识别和风险防范控制。从我国中药企业在国际化的过程中，向欧盟地区注册申请传统植物药这个领域，分析我国企业目前遇到的问题和障碍，对于问题的原因进行剖析，并试图应用项目管理领域的风险管理理论，分析这一类项目中出现的特定风险的特征，为规划风险管理提供依据，进而更好的识别项目的风险，并为制定风险的应对策略提供基础。从技术方面，由于注册方式差异、文档的管理方式存在差异，在项目的进行中应采取外包和采购的方式进行风险转移。在市场风险方面，由于欧洲复杂的文化传统背景，对于目标市场的选择和市场的定位存在风险，要求企业采取市场调研等方式，提前分析目标国家的市场情况和自身药品的适应症情况，避免选择错误的市场进行注册，造成资源和成本的浪费。从政策角度，欧盟GMP认证要求是强制要求，要求企业在项目开始前尽早通过该认证，避免在项目进行中进行认证造成项目延期，而欧盟注册传统植物药指令所要求的用药记录15年等要求，需要进行适当的法律解读，并保持和欧盟相关监管部门进行流畅而持续的沟通，保证企业的产品符合相关法律法规的要求。从管理风险角度，此类项目具有项目周期长、投入成本相对较高的特点，需要复合型人才，且需要调动企业各个业务部门的人员配合参与项目的不同阶段，故而在人力资源管理方面和沟通管理方面存在比较大的风险，容易对项目的达成目标造成不确定的影响。因此应在项目初期进行人力资源管理计划的制定和沟通管理计划的制定，以保证项目在实施的过程中，对于人力资源和沟通等方面的管理问题风险进行防范。 本研究按照提出问题、分析问题、提供解决问题的方案的思路进行。通过一家中药企业注册欧盟传统植物药的案例，论证风险管理理论应用于中药注册欧盟传统植物药项目中的必要性，通过对中药注册欧盟传统植物药项目的特征分析，进行风险识别和风险应对方案的制定，给其他企业在开展注册欧盟传统植物药项目以参考和建议。本研究的创新点在于对我国中药企业进行注册欧盟传统植物药项目的现状和欧盟政策法规进行分析和梳理后，结合某企业进行注册欧盟传统植物药的项目案例，根据项目的特殊性，对项目中存在的风险管理问题进行分析，并提出注册欧盟传统植物药项目中，如何识别风险和对风险应对措施的最佳实践。本研究结合一个企业通过简化程序注册欧盟传统植物药，并成功顺利完成提交的项目的案例分析，分析该企业在项目的实施过程中，如何使用项目管理理论和方法，尤其是风险管理的方法，在项目的实施过程中，进行风险识别，根据风险识别的优先级规划了风险应对的措施。在A企业实施欧盟植物药注册项目过程中，运用风险管理理论，从技术、市场、政策和管理四个维度进行风险识别和风险防范措施制定，针对A企业在市场和政策方面优势，接受市场和政策两个维度的风险，对于技术和管理两个维度的风险进行针对性的防范措施，实践证明，合理的风险应对措施，可以帮助企业在注册欧盟传统植物药项目中更好的完成项目的目标结果。 同时，为了让更多的中药以药品的身份进入欧盟和其他海外市场，实现中药的现代化发展，并发扬广大中医中药文化。建议我国政府和相关药品管理部门应该尽快和欧美先进标准体系接轨，尤其是GMP标准和通用电子文档标准方面，避免企业在国内一套标准海外一套标准，造成巨大的人力物力浪费。并且，在中药企业进军海外的过程中，国家应制定相关政策和指引性法律规定，避免企业在国际化进程中走弯路，同时，国家应制定更多的更准确并能够解决企业实际困难的产业扶持政策，成为企业进军海外的坚强后盾，为更多的中药企业更快的走向世界舞台提供政策基础。 关键词: 中药，欧盟传统植物药，风险管理
英文摘要：	Abstract The EU, as one of the world's largest herbal market, the market size of about $ 25 billion, but our Chinese exports to the EU region, due to the influence of the EU in 2004 promulgated the "traditional herbal registration process instruction", and from 2011 April 30 start date, not by the name can not be registered herbal medicines sold in the EU, but only his capacity as health care or food additives were in circulation, and strictly limited to labeling indications and efficacy are not allowed. According to statistics, in the period before the application of the Act and more than 1000 cases of traditional herbal adopted and not a figure of Chinese enterprises. This is a direct result since 2011, China's exports dropped significantly in sales of proprietary Chinese medicines in the European Union. However, with the March 14, 2012, Chengdu Diao Pharmaceutical Group to develop and produce "Diao Xinxuekang Capsule" traditional herbal Netherlands won Food and Drug Administration marketing approval, to become China's first case of access to medicines in the EU identity of Chinese medicine products. More Chinese enterprises found that the application for registration to the EU is not unattainable, our government has made to encourage Chinese enterprises by improving quality standards, through Chinese medicine innovation and improve manufacturing processes, to better promote Chinese medicine culture policy in this context next, more and more Chinese enterprises began to choose their own varieties of Chinese medicine, traditional herbal medicine to carry registered EU project, on the one hand broaden their overseas markets, on the one hand to enhance their brand value. However, traditional herbal medicine registered EU projects with high complexity and difficulty of the project, enterprises to carry out such projects of high input costs, long project cycle, uncertainty is high, there is a big risk. In this study, analysis of Chinese enterprises registered traditional herbal EU project status and difficulties, from project management perspective, through the application of project management theory of risk management knowledge, analysis of traditional herbal medicine registered EU project characteristics, from technical, market, policy and management aspects, how to conduct risk identification and risk control. Risk management theory of traditional Chinese medicine enterprises from the process of internationalization, the EU application for registration of traditional herbal medicine in this area, analyze problems and obstacles encountered by Chinese enterprises at present, to analyze the cause of the problem, and try to apply project management field analysis of specific risk characteristics of this type of project appears to provide a basis for planning and risk management, and thus risk better identify projects and provide a basis for the development of coping strategies risk. From a technical aspect, since the difference in registration mode, there are differences in management style of the document, in the progress of the project should be taken in the way outsourcing and procurement risk transfer. In terms of market risk, due to the complexity of the European cultural tradition background, the target market selection and positioning market risk, require companies to take market research, etc., early indications situation analysis target country market conditions and their own medicines, avoid selecting Error market registered, resulting in a waste of resources and costs. From a policy perspective, the EU GMP certification requirements are mandatory, require companies as soon as possible before the start of the project through the certification, certification avoid causing project delays in the project, whereas the EU registration of traditional herbal medication records required by the instruction requirements for 15 years , the need for proper legal interpretation, and to maintain and EU regulatory authorities smooth and continuous communication to ensure the company's products comply with the relevant laws and regulations. From the perspective of risk management, such projects have long project cycle, characteristics of the relatively high cost of inputs, complex talent needs, and the need to mobilize the personnel Enterprise various business units with different stages involved in the project, and therefore in the human resources management and communication the presence of a relatively large risk management, the impact is likely to cause uncertainty in reaching target project. So should develop human resource management plan development and communication management plan early in the project to ensure that in the implementation of the project, for the management of human resources and risk communication and other aspects of prevention. In this study, according to ask questions, analyze problems and to provide solutions to the problem ideas were. EU registered via a traditional herbal medicine business case, risk management theory to demonstrate the need for the EU registration of traditional herbal medicine in the project, through the traditional herbal medicine registered EU projects feature analysis, risk identification and risk response plan development, to other enterprises in the EU to carry out registration of traditional herbal medicine project reference and recommendations. The innovation of this study is to carry out the status quo of Chinese enterprises registered traditional herbal EU projects and EU policies and regulations, analyze and sort out later, a combination of EU enterprises Projects registered traditional herbal medicine, according to the special nature of the project, the project in the presence of risk management issues, and put forward the EU registration of traditional herbal medicine project, how to identify risks and risk responses best practices. In this study, combined with a business registration procedures by simplifying EU traditional herbal medicine, and the successful completion of the project submitted by the successful case studies, analysis of the enterprise in the implementation process of the project, how to use project management theory and methods, especially risk management approach, In the implementation process of the project, risk identification, risk identification based on the priority of planned measures to deal with the risk. A business in the implementation of the EU project herbal registration process, the use of risk management theory, risk identification and risk prevention measures from the technical, market, policy and management of the four dimensions of the development, the advantages of the enterprise in the market for the A and policies, market acceptance and two dimensions of risk policy, technology and risk management for the two dimensions of targeted preventive measures, proved reasonable risk response measures can help businesses target the EU registration of traditional herbal medicine and better projects completed projects result. Meanwhile, in order to allow more medicine to identity drugs entering the EU and other overseas markets and achieve modernization of traditional Chinese medicine, and carry forward the majority of Chinese medicine culture. We recommend that our government and relevant departments should Drug Administration and European integration advanced standards as soon as possible, especially GMP standards and common standards for electronic documents, to avoid a standard domestic enterprises in overseas set of standards, resulting in a huge waste of human and material resources. And, in the process of Chinese enterprises to expand overseas, the state should develop policies and guidelines of the law, to avoid detours business internationalization process, while the state should develop a more accurate and more able to solve the practical difficulties of industrial enterprises support policies, become strong backing to expand overseas, as more Chinese enterprises to the world stage to provide faster policy foundation. Key Words: Chinese Medicine; EU Traditional Herbal Medicine; Risk Management;
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