Explorations And Discussins On The 《Guidance For Industry Botanical Drug Products》

FDA (the Food and Drug Administration) of the United States delared the "Guidance For Industry Botanical Drug Products " in 2000 August on the Internet. The 《Guidance For Industry Botanical Drug Products》, was firstly drafted by the FDA in 1996 August 16.The "Guidance For Industry Botanical Drug Products" clearly points out that the botanical drug products is different from chemistry medicine, and admit the function of several botanical products .On account of FDA of the United States is the authority in the international drugs administration, the " Guidance For Industry Botanical Drug Products" become an importance marking . It shows that the United States , together with other countrys, is making good use of the advanced management method to new drug, making use of modern science technique to the research and development the new botanical drug products.The Chinese traditional medicine includes the herbal medicine, animal medicine, mineral medicine, among which the herbal medicine is facing the vigorous competition with challenge.This thesis contains 3 main purposes:Firstly , the thesis manage to reflect to the front of the administration to the new botanical drug products.Secondly, import some of the advanced administrational methods.Thirdly, supply some advice to application for new botanical drug products.