Information on prior human use may substitute for animal toxicology studies. The non-clinical evaluation may be reduced or delayed for certain botanical products entering phase 1 and 2 trials.
Flexible CMC approach is emphasized:
Identification of active components in a botanical mixture may not be necessary, but relevant chemical marker(s) are needed for quality control.
Further purification generally not needed, but additional control of botanical raw material needed.
The overall clinical efficacy and safety requirements are the same for both botanical and non-botanical drugs in order to obtain NDA approval.