Determining which sources of evidence of traditional use are relevant All (and only) information that is relevant to proposed listable indications must be considered as part of the relevant body of evidence. The following table provides guidance on the inclusion and exclusion of items of evidence from further analysis based Excellent Good Satisfactory Unsatisfactory Relevance Identical active Identical active Identical of Different to ingredient, ingredient and administration, active medicine dosing details route of comparable ingredient or and route of administration, active of administration. comparable ingredient or administration. dosing details, formulation dose form and dosing details formulation. and dose form. Relevance Traditional Traditional Some Major population is population is differences differences or to target population identical to the comparable to between differences of target the target traditional uncertain population. population. population and clinical target significance populations but exist between traditional and ‘clinically reasonable’ to target extrapolate populations. evidence to the target population. Relevance The wording of The wording of The wording for The wording to the indication the indication the indication is and intent for traditional is identical to is identical in identical in the indication health item of intent to item intent to item of is inconsistent benefit evidence, of evidence, evidence, but with the item including, the including, the using of evidence. use of use of contemporary traditional traditional terminology terminology. terminology (modern (traditional synonym used synonym used to describe the to describe the traditional indication). indication). Relevance Clearly Identified Identified Not consistent to identified and within the within the with the traditional used relevant relevant relevant context continuously traditional traditional traditional within the paradigm but paradigm with paradigm. relevant with disclarity disclarity traditional regarding regarding paradigm over consistency of consistency of
Determining which sources of evidence of traditional use are relevant All (and only) information that is relevant to proposed listable indications must be considered as part of the relevant body of evidence. The following table provides guidance on the inclusion and exclusion of items of evidence from further analysis based Excellent Good Satisfactory Unsatisfactory Relevance to medicine Identical active ingredient, dosing details and route of administration. Identical active ingredient and route of administration, comparable dosing details, dose form and formulation. Identical of administration, comparable active ingredient or formulation dosing details and dose form. Different active ingredient or of administration. Relevance to target population Traditional population is identical to the target population. Traditional population is comparable to the target population. Some differences between traditional population and target populations but ‘clinically reasonable’ to extrapolate evidence to the target population. Major differences or differences of uncertain clinical significance exist between traditional and target populations. Relevance to traditional health benefit The wording of the indication is identical to item of evidence, including, the use of traditional terminology. The wording of the indication is identical in intent to item of evidence, including, the use of traditional terminology (traditional synonym used to describe the indication). The wording for the indication is identical in intent to item of evidence, but using contemporary terminology (modern synonym used to describe the traditional indication). The wording and intent for the indication is inconsistent with the item of evidence. Relevance to traditional context Clearly identified and used continuously within the relevant traditional paradigm over Identified within the relevant traditional paradigm but with disclarity regarding consistency of Identified within the relevant traditional paradigm with disclarity regarding consistency of Not consistent with the relevant traditional paradigm.
consult-cm-evidence-listed-medicines-120827-a.docx