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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
Consistent with their low risk status, listed medicines may only use low level indications that will not lead to their unsafe or inappropriate use. From March 2018 all medicines listed under section 26A of the Act (AUST L listed medicines) must:
- only use indications included in the Therapeutic Goods (Permissible Indications) Determination
- must comply with all requirements relating to the use of those indications
A 3 year transition period is in place (ending 6 March 2021) for sponsors of medicines listed under s26A of the Act before 6 March 2018, to meet the new requirements for indications. At the end of the transition period, listed medicines that do not meet the legislative requirements for permitted indications will be cancelled from the ARTG. You cannot supply a medicine that is cancelled from the ARTG in the Australian market. For more information on the transition arrangements go to Permitted indications for listed medicines on the TGA website.
Medicines listed under section 26AE of the Act [AUST L(A) assessed listed medicines] may use indications included in the Permissible indications Determination and in addition, must have at least one intermediate level indication related to the assessed pathway. The efficacy of the medicine is assessed by the TGA prior to ARTG entry. For more information on the regulatory and evidence requirements for AUST L(A) assessed listed medicines, refer to Assessed listed medicines evidence guidelines.
Indications included in the Permissible indications Determination have been assessed against a set of criteria and determined to be appropriate for listed medicines. These criteria are intended to ensure that permitted indications will only cover (and AUST L listed medicines will be limited to making) indications relating to:
- health maintenance
- health enhancement
- prevention of a non-serious vitamin or mineral dietary deficiency
- a non-serious form of a disease, ailment, defect or injury
To be consistent with their low risk status, regulatory requirements are placed on the use of certain indications in listed medicines. These are specified in the Permissible Indications Determination.
See Permitted indications for listed medicines guidance for more information on: what permitted indications for listed medicines are including: terminology; structure; use; and applying for new indications.
Indication types and evidence requirements
The Permissible Indications Determination specifies the type of evidence (traditional or scientific) that must be held by sponsors to support the use of each permitted indication for listed medicines. The types of indications and evidence sources are described in Table 1 below.
|Type of indication||Type of evidence|
|Scientific indications||Must be supported by scientific evidence, such as clinical studies or systematic reviews, for example: 'Help maintain/support bone mineralisation'.|
|Traditional indications||Must be supported by evidence of traditional use in a recognised paradigm outside modern conventional medicine. These include indications that can be used across different traditional paradigms, for example: 'Blood cleanser/purifier'.|
|Traditional Chinese medicine indications||Must be supported by evidence of traditional use within traditional Chinese medicine (TCM). These indications use specific terminology used in TCM, for example: 'Traditionally used in Chinese medicine to warm and nourish yang'.|
|Traditional Ayurvedic indications||Must be supported by evidence of traditional use within traditional Ayurvedic medicine. These indications use specific terminology used in Ayurvedic medicine, for example: 'Traditionally used in Ayurvedic medicine to relieve aggravated vata'.|
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 indication sub-type does your evidence of traditional use support?' and 'What indication sub-type does your scientific evidence support?').
Note that indications included in Permissible Indications Determination are not categorised as 'Specific' or 'Non-specific'. The overall presentation of a medicine, including such things as the combination of indications and product name will be considered when determining if indications are specific or non-specific for a particular medicine.
Table 2 and 3 provides examples of non-specific indications.
|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.||
'Maintain general health and wellbeing'
'Traditionally used in Ayurvedic medicine to maintain/support healthy digestion'
|Relief of general symptoms||Symptoms not related to a named condition||
'Decrease/reduce/relieve skin redness'
'Traditionally used in Chinese medicine to relieve muscle pain'
|General nutritional supplementation (scientific indications only)||
Supplementation with vitamins, minerals or other essential nutrients 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.
|'Maintain/support calcium levels in the body'|
|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 enhance blood circulation to the peripheral areas of the body (legs, hands and feet)'
'Traditionally used in Western herbal medicine to promote healthy digestion'
|Reduce occurrence or frequency of a named condition, symptoms or discrete event||Reduce the occurrence of a specified, non-serious illness, condition, disease or disorder.||
'Help reduce occurrence of symptoms of medically diagnosed Irritable Bowel Syndrome'
'Traditionally used in Australian indigenous medicine to help reduce occurrence of abdominal bloating'
|Management or relief of symptoms linked to a named symptom/disease/ disorder condition||Reduces the frequency, duration and/or severity of symptoms associated with a named illness.||
'Relieve symptoms of hayfever'
'Traditionally used in Western herbal medicine to relieve symptoms of indigestion/dyspepsia'
|Improved quality of life without resolution of the underlying non-serious illness, condition, disease or disorder.||
'Enhance/improve/promote/increase bowel regularity'
'Traditionally used in Western herbal medicine to decrease symptoms of mild arthritis/osteoarthritis'
|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).||
'Support calcium absorption in bones to promote bone strength'
'Helps increase body utilisation of magnesium to help reduce occurrence of muscle cramp'
When you enter your medicine in the electronic Listing Facility (ELF), you may also choose to select indication qualifiers from drop down lists to make a permitted indication more specific and align with the evidence you hold for your medicine. For more information see:
- Permitted indications for listed medicines guidance
- Listed medicines application and submission user guide for information on selecting indication qualifiers
Evidence to support indications for listed medicines
The term 'evidence' refers to both information and evidence as described in paragraph 26A(2)(j) and subsection 28(6) of the Act.
As the sponsor of a listed medicine, you must hold evidence to support all the indications you make for your medicine at the time you list the medicine in the ARTG. The evidence you hold must adequately support all indications and demonstrate all claims made for the medicine are true, valid and not misleading. You must keep that evidence for the whole time the medicine remains listed and provide it to the TGA if requested to do so [as provided by subsection 26A(2)(j) and 28(6) of the Act].
What type of evidence do you have to support your indication?
Before deciding the indication/s for your medicine, you must determine the type of evidence you have on which to base the indication. That is, do you have evidence of traditional use or scientific evidence? And, is the evidence you hold supportive of a specific or non-specific indication?
Your evidence must:
- have the same meaning and intent as the selected indication
- be related to the same medicine or active ingredient/s; and
- have the same therapeutic action and the same context, for example: the same target population; the same traditional paradigm.
Where there are differences between the ingredient and reported therapeutic benefit, a justification will be required in your evidence package to address the discrepancy.
Do you have evidence of traditional use?
Traditional medicines are based on an extensive history of use, often measured over thousands of years. This history provides an accumulated repository of systematic observation and underpins the use of these medicines in a traditional setting. Usually when a medicine or a relevant ingredient in the medicine has been used over a long period of time its dosage and formulation have been refined by experience to maximise therapeutic effectiveness and minimise risk.
Evidence of traditional use for an indication needs to show that the medicine or the relevant ingredients in the medicine have a significant history of use in the specified tradition for the specified therapeutic purpose. You are required to hold documentary evidence that your medicine or its active ingredient has been used for at least three generations (at least 75 years) in the tradition it belongs to. This will establish that it belongs to that tradition and that there is an accumulated repository of observations in humans that underpins the use of the medicine.
For many traditional medicines there has been little quantifiable scientific research, scientific assessment or scrutiny undertaken on the medicine's mode of action or effect. It is inappropriate to use evidence of traditional use to support a scientific claim of efficacy, a mechanism of action or an underlying physiological process, as these are required to be supported by scientific evidence.
If you have determined that the evidence you have is traditional, 'What evidence do you need to support your traditional indication?' provides guidance on compiling your evidence package.
Do you have scientific evidence?
Scientific evidence refers to quantifiable data and usually includes reports of clinical trials in humans, human epidemiological studies, animal studies and other cellular or pharmacological studies. Due to the quantifiable nature of scientific evidence, scientific indications can imply clinical efficacy where the indication is supported by such data.
Examples of scientific evidence include:
- systematic reviews
- reports of clinical studies
- peer-reviewed published review articles; and
- pharmacopoeias and monographs.
If you only have non-clinical studies, cellular or pharmacological studies, these alone are not considered sufficient evidence to support a scientific indication. However, such studies can be used to provide secondary support to human data.
If you have determined that the evidence you have is scientific, 'What evidence do you need to support your scientific indication?' provides guidance on compiling your evidence package.
Do you have a combination of scientific evidence and a history of traditional use (cross-evidence base medicine)?
It is possible for a listed medicine to have scientific and traditional indications where there is a combination of traditional and non-traditional ingredients (cross-evidence base medicine) with a similar therapeutic purpose. Also, it is possible that an ingredient in a cross-evidence base medicine may have evidence of traditional use that is also supported by current scientific literature (cross-evidence base ingredient).
Each scientific or traditional indication requires supportive evidence and the indications must indicate the evidence source (that is, traditional indications must include the traditional context of use).
If you have a combination of scientific and traditional evidence for your medicine, 'Cross-evidence base medicine: What evidence do you need to support your medicine with a combination of traditional and scientific indications?' provides guidance on compiling your evidence package.
How to source, assess, record and present evidence to support your indication
Before listing your complementary medicine, you should compile an evidence summary to support your traditional, scientific or 'cross evidence base' indications. Your evidence summary should show that you have conducted an objective, comprehensive, transparent and robust review of the literature relating to your indication. The resulting evidence you hold should be of high quality, credible and relevant to your medicine.
Evidence package checklists available on the TGA website help you sift through the available literature to identify what is appropriate evidence and exclude what is not. The checklists will assist you to collate and compile your evidence summary and determine which evidence items are credible, relevant and of high quality.
As a mechanism of establishing that you have the evidence to support your indications, you should consider completing the appropriate checklists for your medicine and associated indications, before listing your medicine on the ARTG. You should hold all the information contained within the checklists for your medicine and submit this information to the TGA when requested to do so.
During a compliance review of your medicine, the TGA may request the evidence you hold to support the indications you make for your medicine. At this time, you may include the appropriate checklists (or similar information) as part of your response to the TGA's request for information. While presenting your information in the provided checklist format is not mandatory, submitting information in this format will help facilitate and expedite the compliance review process.
Diagram 1 provides a general flow chart on the steps for compiling your evidence package for your listed medicine. Detailed guidance on compiling traditional or scientific evidence packages is provided in: