reasonable’ to exist between extrapolate traditional and evidence to the target target population. populations. Relevance The wording of The wording of The wording for The wording to the indication the indication is the indication is and intent for traditional is identical to identical in intent identical in intent the indication health item of to item of to item of is inconsistent benefit evidence, evidence, evidence, but with the item of including, the including, the use using evidence. use of of traditional contemporary traditional terminology terminology terminology. (traditional (modern synonym synonym used to used to describe describe the the traditional indication). indication). Relevance Clearly Identified within Identified within Not consistent to identified and the relevant the relevant with the traditional used traditional traditional relevant continuously paradigm but with paradigm with traditional context within the disclarity some disclarity paradigm. relevant regarding regarding traditional consistency of use characterisation of paradigm over over a period of the active at trial 75 75 years. ingredients or years. formulation. Only of evidence achieving ratings of or above in ALL four relevance categories are ‘satisfactory’ considered relevant to a proposed listable indication. All items achieving four ratings of or above ‘satisfactory’ must be included in the analysis of evidence, and those not achieving this ranking must be excluded. 3.2.2.6 Quality of relevant evidence When supporting evidence includes independent written histories of use in the classical or traditional literature, the significance and clarity of references to any health benefit must be assessed. The assessment of quality must consider how well the: traditional paradigm has been defined ingredient(s)/product has been characterised preparation has been described dose and dosing details have been documented route of administration has been specified target population has been defined; and
reasonable’ to extrapolate evidence to the target population. 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 at 75 years. Identified within the relevant traditional paradigm but with disclarity regarding consistency of use over a period of 75 years. Identified within the relevant traditional paradigm with some disclarity regarding characterisation of the active ingredients or formulation. Not consistent with the relevant traditional paradigm. Only of evidence achieving ratings of ‘satisfactory’ or above in ALL four relevance categories are considered relevant to a proposed listable indication. All items achieving four ratings of ‘satisfactory’ or above must be included in the analysis of evidence, and those not achieving this ranking must be excluded. 3.2.2.6 Quality of relevant evidence When supporting evidence includes independent written histories of use in the classical or traditional literature, the significance and clarity of references to any health benefit must be assessed. The assessment of quality must consider how well the: traditional paradigm has been defined ingredient(s)/product has been characterised preparation has been described dose and dosing details have been documented route of administration has been specified target population has been defined; and trial
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