植物药美国上市的法规研究

发布时间：2018-03-08 15:07

本文选题：植物药　切入点：植物药产品　出处：《上海交通大学》2010年硕士论文　论文类型：学位论文

【摘要】： 在回归自然的世界潮流下,随着医疗保健费用越来越昂贵,人口的老龄化发展,人们更加看重养生保健。植物药因其直接来源于自然,毒副作用相对化学药和天然药较小,同时成本较低,日益受到美国民众的青睐。美国是全球最为发达的医药市场,它的发展与变化直接影响着世界医药市场。亚洲是传统的植物药发源地,尤其是中国。中国作为中药的发源地,使用历史悠久,中药中绝大多数是植物药。当前我国中药的发展仍处于较低的水平,中药市场的国际贸易中主要是出口初级的原材料和提取物。如何促进我国中药,尤其是促进植物药的发展并与欧美主流医药市场接轨,这是当前国内制药业界面对的主要问题。美国是全球最大的药品市场,要把植物药推向美国市场,必须首先了解美国对于植物药的有关法律、法规。同时,随着植物药技术的发展和美国民众对植物药产品的实际需求, FDA(Food and Drug Administration)对植物药的政策不断转变。2004年6月《植物药指南》的正式发布,以及2006年10月底FDA成功批准的第一个植物药上市表明,植物药以药品形式在美国上市成为可能。如何根据当前FDA评审政策的要求,促进国内企业对美国FDA法规熟悉和了解,促进我国植物药走向美国等世界医药市场,是我们迫切面待和需要解决的问题。本研究采用统计分析、比较对照、案例研究等方法进行,明确美国将是植物药潜在的巨大市场;同时分析植物药产品在美国上市的两条主要途径饮食补充剂和药品;而药品又包括非处方药和新药申请(NDA, New Drug Application)两种截然不同的形式。研究阐述了以饮食补充剂和药品上市所涉及的法规的差异,提出以药品形式上市将是植物药产品发展的主流方向。《植物药指南》是植物药的企业研究和FDA批准的法规性依据,本文总结了指南中植物药临床前研究和临床研究的要求。通过FDA批准的第一只植物药VeregenTM产品进行案例分析,提出我国植物药发展的几点思考,希望能促进国内企业对美国上市植物药法规有深入的了解。
[Abstract]:In the natural world, with health care costs more and more expensive, the development of aging population, people pay more attention to health care. Because of its medicinal plants directly from nature, side effects of chemical medicine and natural medicine is relatively small, and low cost, has been to the United States the United States is the most popular among people. Developed medicine market in the world, its development and change directly affects the pharmaceutical market in the world.
Asia is the birthplace of traditional medicinal plants, especially China. Chinese as the birthplace of traditional Chinese medicine, has a long history, the vast majority of Chinese medicine is plant medicine. The current development of Chinese medicine in our country is still at a relatively low level of Chinese medicine market in international trade is the main export of raw materials and how to promote the extract. China's traditional Chinese medicine, especially in promoting the development of plant medicine and integration with the mainstream pharmaceutical market in Europe and the United States, this is the main problem facing the domestic pharmaceutical industry.
The United States is the world's largest pharmaceuticals market to plant drugs into the U.S. market, we must first understand the relevant laws of the United States, for plant medicine regulations. At the same time, along with the development of plant medicine technology and the American people on the actual demand of herbal products, FDA (Food and Drug Administration) to plant medicine policy changing.2004 June < > plant medicine guide officially released, and the first plant medicine at the end of October 2006 FDA approved listing shows that plant medicine in the form of drugs listed in the United States as possible. According to the current FDA review policy requirements, promote domestic enterprises to understand and familiar with FDA of the United States laws and regulations, promote our country to plant drugs such as the United States the pharmaceutical market, we face to be urgent and need to solve the problem.
This study uses statistical analysis, comparative method, case study, made clear that the United States would be a huge market potential and analysis of medicinal plants; herbal products in the United States listed the two main ways of dietary supplements and drugs; and drugs including non prescription drugs and new drug application (NDA, New Drug Application) two distinct the study illustrates the differences in form. Dietary supplements and drugs listed related regulations, presented in the form of drugs listed will be the mainstream direction of plant medicine product development. Plant medicine guidelines > is a legal basis for approval of plant medicine enterprise research and FDA, this paper summarizes the requirements of plant medicine preclinical research and clinical research the guide for case analysis. Through the FDA approved the first drug VeregenTM plant products, proposes several thoughts for development of plant medicine in China, hoping to promote the domestic enterprises of the United States There is a deep understanding of the listed plant drug regulations.

【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：D971.2;DD912.1

【引证文献】