Traditional Chinese medicines: Regulatory and scientific challenges

Development of multi-component botanical products as pharmaceutical drugs requires control of consistency. The foundation for consistency, which provides the basis for establishing comprehensive specifications is based on control of the biomass and thorough characterization of the extract. Validation of the manufacturing process ensures that the specifications are reproducible. Traditional Chinese Medicines require a special focus on defining the composition of the pharmaceutical product to be developed, understanding the biomass pretreatment chemistry, characterizing the multiple herb mixture, and conforming to drug Good Manufacturing Practices (GMP).