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Guidelines on the evidence required to support indications for listed complementary medicines
Cross-evidence base medicine: What evidence do you need to support your medicine with a combination of traditional and scientific indications?
A listed medicine can have a combination of scientific and traditional indications where:
- an ingredient in the medicine is supported by both scientific evidence and evidence of traditional use ('cross-evidence base ingredient')
- the medicine contains both traditional and non-traditional ingredients with associated traditional and scientific indications ('cross-evidence base medicine')
It is important that the indications for your listed medicine accurately describe the evidence base for the indication. You are also required to have supportive evidence for all your traditional and scientific indications. Refer to:
- Traditional indications: what evidence do you need to support your traditional indication?
- Scientific indications: what evidence do you need to support your scientific indication?
Cross-evidence base ingredient (scientific and traditional)
In cases where you have supportive evidence of traditional use and scientific evidence for an ingredient, both scientific and traditional indications may be made for that ingredient.
Example: Indications for a 'cross-evidence base ingredient'
A medicine contains Evening Primrose seed oil (EPO) with a high gamma-linolenic acid content.
Potential permitted indications included in ARTG (if supported by evidence):
'Traditionally used in Western herbal medicine to relieve symptoms of mild eczema/dermatitis'
Linked symptom indication: 'Soothe/relieve skin inflammation'
Potential indications on the medicine label
'Evening primrose seed oil (EPO) has been used traditionally in western herbal medicine to relieve symptoms of mild eczema, such as skin inflammation. Gamma-linolenic acid is a component in EPO that has anti-inflammatory properties.'
If you are aware that there is conflicting evidence between the history of traditional use and contemporary scientific evidence for your medicine, then it is advisable to include a statement to this effect in any labelling and advertising associated with the medicine, for example: 'this traditional use is not supported by scientific evidence'. This will ensure that the advertised information relating to your medicine is truthful, valid and not misleading.
Cross-evidence based medicine
A medicine with a mixture of scientific and traditional indications (mixed paradigm medicine) with traditional and non-traditional ingredients requires scientific evidence to support the scientific indications and evidence of tradition of use to support the traditional indications.
Where your medicine contains multiple ingredients, with some associated with scientific indications and others with traditional indications, the kind of evidence supporting each indication must be clearly communicated to the consumer.
Evidence may refer to a formulation or an ingredient of the medicine. Indications must only refer to entire formulations or specific combination of ingredients for which the evidence is held. When evidence supports a health benefit for one or more ingredients in the medicine (but not the medicine as a whole) indications must include this information.
Example: An indication for a cross evidence base medicine
A medicine that contains Echinacea purpurea and ascorbic acid (vitamin C).
Potential permitted indications in the ARTG (if supported by evidence):
'Traditionally used in Western herbal medicine to enhance/improve/promote immune system function'
'Maintain/support immune system health'
Potential indications on the medicine label
'This medicine has been formulated from traditional and modern ingredients for a healthy immune system function. Echinacea purpurea has been traditionally used in Western herbal medicine to promote immune system function. Vitamin C supports immune system health.'
How to compile a summary of the evidence to support your indication for your cross-evidence based medicine
You should compile an evidence summary demonstrating that you have conducted an objective, comprehensive and transparent review of the literature relating to your indication/s. The resulting evidence you hold must be relevant to your medicine, be of high quality and adequately demonstrate that all indications claimed for your medicine are true, valid and not misleading.
Evidence package checklists provided on the TGA website assist you to collate your evidence summary and filter evidence items to those that are credible and relevant to your medicine. You are required to hold all the information contained within the relevant forms for your medicine before listing it. Refer to the Appendix 1: How to use evidence package checklists for assistance with the process. While presentation in this manner is not compulsory, it will expedite the compliance review process, should your medicine be selected for an evidence compliance review.