Developing Herbal Medicine to Botanical Drugs
US FDA botanical drug Development Guidance for the Industry has opened a door for botanical products, such as herbal medicine or cannabis products to apply as botanical drugs. Examples of herbal medicines in various US FDA regulatory filing for prescription botanical drugs are listed below.
All of those TCMs are currently widely used in China for many decades: their safety and efficacy have already been known and demonstrated on large population. Developing those TCMs to US prescription botanical drugs is a efficient drug development pathway.