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Guidelines on the evidence required to support indications for listed complementary medicines
Part A: Evidence to support indications for listed complementary medicines
Indications for listed medicines
In relation to therapeutic goods, the definition of 'indications' is provided in Section 3 of the Therapeutic Goods Act 1989 (the Act) as: 'the specific therapeutic use/s of the goods'.
The indication of a medicine is its claimed purpose or health benefit, for example: 'relieves coughs'.
What is not an indication?
Statements or claims which do not convey a specific therapeutic use such as references to the properties of the product or the packaging are not considered to be therapeutic indications. Some examples are:
- 'contains 25% more'
- 'new formula'; and
- 'high in vitamin C'.
Indications must be included in the ARTG entry for a medicine, whereas other claims not related to therapeutic use are not required to be in the ARTG. However, sponsors must hold evidence to support both indications and other claims for their medicine.
Any statement you make in relation to the medicine, such as marketing claims, must be truthful, factual and not misleading. Refer to the Therapeutic Goods Advertising Code (TGAC) for details of advertising requirements.
What indications are suitable for use in listed medicines?
Consistent with their low risk, listed complementary medicines may only carry appropriate indications that will not lead to their unsafe or inappropriate use.
When listing a medicine, you must certify3 that the medicine is eligible for listing. To be eligible for listing (pursuant to Schedule 4 of the Therapeutic Goods Regulations 1990), the indications for the goods must not refer to the treatment of specified types of diseases, conditions, ailments or defects4.
In addition, to be included on the label, an indication must not refer to a serious form of those diseases, conditions, ailments or defects without prior approval by the TGA5. Serious forms include conditions which are generally accepted not to be diagnosed, treated or managed safely without the assistance of a qualified healthcare practitioner.
In general, an indication suitable for use in listed medicines:
- will describe a specific therapeutic use
- may refer to health maintenance and/or health enhancement
- may not refer to the treatment or cure of a disease, ailment, defect or injury; and
- may not refer to a serious form of a disease, ailment, defect or injury.
Indications not suitable for listed medicines
In general, indications that refer (explicitly or implied) to the treatment, or cure of diseases, conditions, ailments or defects are NOT suitable for use in listed medicines.
In specific circumstances, the TGA may allow indications for listed medicines to refer to serious forms of conditions (referred to as restricted representations) where it is considered in the public interest to do so. This can occur upon application by the sponsor for approval to use a restricted representation under s 42DK(1) of the Act.
Should a sponsor wish to make a high-level indication for their medicine, then the product is required to be registered and must undergo full pre-market evaluation by the TGA for quality, safety and efficacy.
What does an indication look like?
An indication must describe the specific therapeutic use(s) of the goods. An indication is made up of the components listed in Table 1.
Context of traditional use
For traditional indications, the indication must include a statement providing the 'context of traditional us, which is the traditional paradigm.
A statement of 'traditional context' is not required for scientific indications.
'Traditionally used in Western herbal medicine...'
'Traditionally used in Chinese herbal medicine...'
|Action||The action or effect.||Reduces; prevents; improves; maintains; stimulates|
|Target||The target may be a biological factor or process, a health state or a clinical condition. Targets may be non-specific or specific.||
Non-specific targets: 'general health and wellbeing'; 'growth and development'
Specific targets: headache; fever; joint pain
|Additional qualifying terms (optional)||Additional qualifying terms may be included to provide information relating to the action, the target or the indication context (of therapeutic use).||
Action qualifiers: helps; assists
Target qualifiers: mild; healthy
Indication qualifier: 'in postmenopausal women'
The structure of an indication is provided in Diagram 1.
Diagram 1: Indication structure
- Indication structure
- TRADITIONAL CONTEXT (if applicable)
- +/- action qualifier (optional)
- +/- target qualifier (optional)
- +/-indication qualifier (optional)
- Indication structure
Examples of indication structure
'Traditionally used in Western herbal medicine (context) to help (action qualifier) reduce (action) mild (target qualifier) nausea (target) in pregnant women (indication qualifier)'.
'For the temporary (action qualifier) relief (action) of mild (target qualifier) headache (target)'.
An indication that does not clearly specify the tradition it belongs to is, by default, scientific and is required to be supported by scientific evidence.
What are the different types of indications?
Traditional and scientific indications are further classified into 'non-specific' or 'specific' sub-types depending on the how the indication is phrased.
What are traditional indications?
Traditional indications belong to a recognised paradigm outside modern conventional medicine. Traditional medicine is an integral part of many cultures and includes a diverse range of health practices, approaches, knowledge sets and belief systems relating to medicines. Examples of traditional medicines include:
- Traditional Chinese Medicine (TCM)
- Aboriginal and Torres Strait Islander healing practices
- Ayurvedic medicine
- Western herbal medicine
- Homoeopathic medicine
- Aromatherapy; and
- other indigenous medicines.
Traditional indications must indicate that the health benefit is based on long-term use and experience in a specific traditional paradigm. As traditional indications are not based on scientific evidence, they cannot imply efficacy in a clinical setting.
Examples of traditional indications:
- 'Traditionally used in Chinese medicine to 'resolve phlegm' to relieve cough'.
- 'Traditionally used in Western herbal medicine to relieve nasal congestion'.
- 'Traditionally used in Homoeopathic medicine to improve appetite'.
- 'Traditionally used in Ayurvedic medicine to support healthy immune function'.
What if your traditional medicine includes multiple ingredients?
For medicines that have multiple active ingredients from the same traditional paradigm, indications can be linked to individual ingredients or relate to the entire medicine (if the indications for each ingredient are traditionally used for the same health benefit).
Example of a traditional indication for multiple ingredients from the same paradigm:
- 'The ingredients in this medicine are traditionally used in Western herbal medicine to maintain a healthy liver function'.
What if your medicine includes multiple ingredients from different traditional paradigms ('multiple traditional paradigm medicine')?
If all the active ingredients from the different traditional paradigms are traditionally used for the same health benefit, the indication/s can be applied to the whole medicine. Alternatively, an indication can be provided for each individual ingredient.
Example of a traditional indication for a 'multiple traditional paradigm medicine':
- 'Ingredients in this medicine have traditionally been used in Ayurvedic and Chinese medicine for relieving common cold symptoms'.
Example of individual indications for different ingredients in a 'multiple traditional paradigm medicine':
- 'Trichosanthis kirilowii (tian hua fen) is traditionally used in Chinese medicine to 'clear and drain lung heat' to help relieve chest congestion' and
- 'Ocimum tenuiflorum is traditionally used in Ayurvedic medicine to help remove excess 'kapha' (mucus) from the lungs and nasal passages'.
What are scientific indications?
Scientific indications belong to conventional modern medicine and are supported by scientific literature, such as clinical studies or systematic reviews (refer to 'Do you have scientific evidence?').
Examples of scientific indications:
- 'Helps relieve common cold symptoms.'
- 'Helps maintain blood circulation to the peripheral areas of the body.'
- 'Assists in the management of mild acne pimples.'
- 'Helps support a healthy immune system.'
What if your medicine has a combination of traditional and scientific indications ('cross evidence base medicine')?
A medicine with a combination of scientific and traditional indications (a 'cross evidence base' medicine) requires scientific evidence to support the scientific indications and evidence of traditional use to support the traditional indications.
Example of indications for a medicine that has cross paradigm indications:
- A medicine that contains Panax ginseng, Bacopa monnieri and folic acid may have the following indications (if supported by appropriate evidence):
- 'This medicine has been formulated from traditional and non-traditional ingredients, to help support a healthy memory, specifically:
- Panax ginseng is traditionally used in Chinese medicine to tonify qi (vital energy) and support memory in times of fatigue.
- Bacopa monnieri is traditionally used in Ayurvedic medicine to improve memory.
- Folic acid helps support cognitive function'.
What are the indication sub-types (specific or non-specific)?
Traditional or scientific indications can be further classified into two sub-types:
Sub-type 1: Non-specific (general indications)
Non-specific indications refer to general health and wellbeing, such as:
- health maintenance
- relief of symptoms not related to a named condition; and
- general vitamin, mineral or nutritional supplementation.
Sub-type 2: Specific indications
Specific indications refer to health benefits beyond general health and wellbeing, such as:
- health enhancement
- reduction of risk or frequency of a named condition or symptoms
- management or relief of symptoms linked to a named condition; and
- nutritional supplementation claims linked to a specific therapeutic benefit.
Whether using traditional or scientific indications, the specificity of your indication determines the level of evidence required to support your indication (refer to 'What level of indication does your traditional evidence support?' and 'What level of indication does your scientific evidence support?')
Tables 2a and 2b provide examples of specific and non-specific indication sub-types.
|Non-specific indications (scientific or traditional)|
|Health benefit||Definition of health benefit||Example of an indication|
|Health maintenance||Normal physiological effects of substances in growth, development and normal functions of the body.||
'Helps maintain general health and wellbeing'
'Traditionally used in Ayurvedic medicine to support a healthy digestion function'.
|Relief of general symptoms||Symptoms not related to a named condition||
'Helps soothe dry skin'
'Traditionally used in homoeopathic medicine to relieve muscle aches and pains'.
|General nutritional supplementation (scientific indications only)||
Supplementation with vitamins, minerals or other essential nutrients (for example: a source of calcium) that imply a general health benefit such as the maintenance of good health.
Note: to make a supplementation claim for a named vitamin or mineral, the product must provide at least 25% of the recommended dietary intake (RDI) for that vitamin or mineral.
'Provides vitamins and minerals to help support the body's nutritional needs'
'Provides vitamin A to help maintain healthy hair and skin'.
|Specific indications (may be scientific or traditional)|
|Health benefit||Definition of health benefit||Example of an indication|
|Health enhancement||Specific beneficial effects of nutrients and other substances on the physiological and psychological state of the body above and beyond normal growth, development and functions of the body.||
'Helps increase blood circulation to the peripheral areas of the body (hands and feet)'.
'Traditionally used in Chinese medicine to stimulate digestion'.
|Reduce risk or frequency of a named condition, symptoms or discrete event||Reduce the risk of a specified, non-serious illness, condition, disease or disorder.||
'Helps reduce the risk/ occurrence of indigestion'.
'Traditionally used in Chinese medicine to reduce the occurrence of common colds.'
|Management or relief of symptoms linked to a named symptom/disease/disorder condition.||Reduces the frequency, duration and/or severity of a symptom or cluster of symptoms associated with a named illness.||
'Helps relive mild dermatitis itchy red skin'.
'Traditionally used in Western herbal medicine to reduce common cold symptoms'.
|Improved quality of life without resolution of the underlying non-serious illness, condition, disease or disorder.||
'Assists in management of mild/moderate indigestion abdominal bloating'.
'Traditionally used in Western herbal medicine to relieve arthritic joint pain'.
|Supplementation indications linked to a specific therapeutic benefit (scientific indications only)||If a supplementation indication is linked to a specific therapeutic benefit, additional supportive scientific evidence is required (as well as the requirement to provide 25% of the RDI for that nutrient).||
'Helps prevent dietary vitamin B12 deficiency'.
'Assists in the management of medically diagnosed dietary vitamin B12 deficiency'.
'Provides calcium to improve bone strength'.
- Section 26A(2)(a) Therapeutic Goods Act 1989
- The diseases, conditions, ailments or defects are listed in Appendix 6 of the Therapeutic Goods Advertising Code 2007.
- Part 5(2) of the Therapeutic Goods Advertising Code 2007.