Exploration And Discussions On The "Guidance For Industry Botanical Drug Products" ( â…¡)

On the June 9, 2004, FDA( Food and Drug Administration)of the United States formally issued the"Guidance for Industry Botanical Drug Products". When the draft is declared, it has called the attention about the policy about the botanical drugs. Also, the guidance has played an active role in promoting the market of R & D and production. Many countries have adjusted their policy of the botanical drugs to adapt the stream of the world, at the same time, it has kept our policy up to date. In October 1, 2007, we issued the new law about the Drug Registration for the new drug development and new drug registration. It has opened up our new horizons to the international drug registration, and made the policy more internationalization,normalization and scientificalization.Researching on this paper is based on the results which are made by Meng Fanli, an upperclassman in our school. And my paper will study through the perspective of Pharmacy Administration, the background of the current international policy on botanical drug research, the focus on the policy emphasis, and the changes of the policy direction in this 7 years in the domestic to analyze the trend of dynamic situation of botanical drugs all over the world. Using the comparative analysis, logical antithesis, illustration and literature retrieval method, also doing a lot of tracking about the Internet News Information to compare the difficulties and difference between the two country in new drug application. Also this paper will discuss the future direction of new drug policy through the illustration of the botanical drug which was first adopted by FDA.