Evidence guidelines

Guidelines on the evidence required to support indications for listed complementary medicines

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24 July 2014

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 proposed 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 or 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 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 2 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:

Diagram 2: Compiling an evidence package to support the indication/s for your listed medicine

For each indication: Complete the Evidence coversheet: Determine the type of indication/claim: Scientific non-specific, traditional non-specific, traditional specific indication, scientific specific indication, Collate evidence and use appropriate checklists, Determine if the evidecne supports the indication? if no, disregard the item.

  1. Complete the Evidence package coversheet for each indication - Go to Step 2
  2. Determine the type of indication you have (traditional non-specific, scientific non-specific, traditional specific or scientific specific)
    1. If you have a Traditional non-specific indication
      1. Source at least two independent primary sources of evidence
      2. Use the 'Evidence of traditional use filter'
      3. Go to Step 3
    2. If you have a Scientific non-specific indication
      1. Source at least two independent primary sources of evidence -
      2. Use the 'Simplified scientific filter'
      3. Go to Step 3
    3. If you have a Traditional specific indication
      1. Document your search strategy and collate primary information sources and supportive secondary sources for your indication
      2. Determine the relevance of evidence to your medicine and indication by using the 'Evidence of traditional use filter'
      3. Go to Step 3
    4. If you have a Scientific specific indication
      1. Document your search strategy and collate primary information sources and supportive secondary sources for your indication
      2. Determine the relevance, quality and the balance of evidence in relation to your medicine and indication by using the 'Scientific evidence filter'.
      3. Go to Step 3
  3. Can the item of evidence support the indication?
    1. No: Disregard this item of evidence
    2. Yes Collate relevant items of evidence in the appropriate evidence summary for your indication.
    3. End diagram

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