Regulation Study For Botanical Drug Product Marketing In USA

Under the world trend of returning to the nature, health care is more and more expensive, and with the population is aging, health care is getting more attention of people. Botanical drug products are directly derived from the nature materials, having the relative lower toxicity compared with chemical drugs, lower cost, they are becoming the focus of the world people. The United States is the world's most developed pharmaceutical market, its development and changes will directly affect the world pharmaceutical market.Asia is the birthplace of traditional plant medicine, especially in China. As the birthplace of traditional Chinese medicine (TCM), the majority of which is botanical drug.TCM has a long history of using, but its exploitation is at a low level. Some primary raw materials and extracts are the main types of exporting. The main subject of Chinese pharmaceutical industry is how to promote Chinese medicine, in particularly to promote the development of botanical drug to arrive at mainstream level of Europe and the United States.U.S. is the largest pharmaceutical market of the world, every company who want enter the market will have to face it. The first thing is to study the laws and regulations related to botanicals. FDA has changed their concept on botanical drug with the current technology development and the actual demand on botanical products from American people. "Guidance for Industry: Botanical drug products" was issued in June 2004 and the botanical drug of VeregenTM was successfully approved by FDA, which means it is possible to for botanical product as a real drug market in U.S.. We should consider the change of FDA's policy, promote domestic enterprises to understand U.S. FDA regulations, help them to enter the United States and other first-class medical market.On the above target, studied used statistical analysis, comparison and contrast, case studies and other methods to concluded that U.S. is a potentially huge market for botanical drug and several different market paths, including dietary supplements and drugs. In which, drug includes OTC and NDA. The difference of laws and regulations on dietary supplements and drugs were comparatively described. Market a botanical products in US as drug may be a major way. Guidance is the base to develop and NDA application. The article summarized the pre-clinical research and clinical research requirements. Some suggestion was given on developing and marketing botanical drug products in U.S. Author hope that it will be helpful to promote Chinese company to know the regulations on Botanical drug products if they want market their products in U.S.