Evidence guidelines

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

Book pagination

24 July 2014

Appendix 1: How to use evidence package checklists

The following guidance assists you complete the evidence package checklists (provided on the TGA website and listed below) for the indications for your listed medicine.

Table: List of checklists and when they should be used
Checklist title Applicable for: Scientific evidence Applicable for: Evidence of traditional use
Checklist 1: Evidence package cover page Yes Yes
Checklist 2: Evidence search strategy Yes Yes

Checklist 3: Evidence of traditional use filter

Guidance to filter your evidence to identify those items that are credible, relevant and of high quality

No Yes

Checklist 4: Scientific evidence filter

Guidance to filter your evidence to identify those items that are credible, relevant and of high quality.

Yes No
Checklist 5: Evidence of traditional use summary No Yes
Checklist 6: Evidence of scientific use summary Yes No

The evidence which supports an indication for each ingredient is drawn from evidence of traditional use, or from other scientific research into the ingredient. Refer to the evidence guidelines for information on type of indications and evidence required to support them.

An indication may be related to one or more active ingredients, or to a fixed combination of active ingredients. For each indication-ingredient relationship, you need to complete the appropriate checklists to document:

  • your search for evidence
  • the findings from your search
  • the credibility of the evidence you wish to use to support the indication or claim; and
  • the relevance and consistency of the evidence, indication and medicine.

Your evidence package should include a summary of the evidence you hold supporting all the indications of your medicine and attached copies of evidence items.

If you have a traditional indication with evidence of traditional use

You are advised to include checklists 1, 2, 3 and 5 in your evidence package.

If you have a scientific indication with scientific evidence

You are advised to include checklists 1, 2, 4 and 6 in your evidence package.

If you have a both evidence of traditional use and scientific evidence

You are advised to include all checklists (1, 2, 3, 4, 5 and 6) in your evidence package.

Top of page

Checklist 1: Evidence package cover page

Complete all sections of this document and attach to the front of your evidence package.

1a: Identification of listed medicine and sponsor details

Provide:

  • the medicine name
  • the medicine's AUST L number [when this has been assigned to the medicine - upon completion of your medicine application via the TGA's eBusiness services (eBs)]
  • your name; and
  • your contact details (as recorded in eBs).

1b: Listed medicine details

Provide general information on your medicine:

  • dosage form, for example: tablet, capsule, oral liquid
  • route of administration, for example: oral or topical
  • intended population, for example: general, children, adults, elderly
  • recommended dose unit, for example: 2 tablets
  • maximum recommended daily dose (MRDD), for example: 6 tablets per day
  • directions for use, for example: 'take 2 tablets before a meal'
  • duration of use (where relevant): 'take for 2 weeks'; and
  • cautions and contraindications, for example: 'not suitable for use in children'.

1c: Listed medicine active ingredients

For each active ingredient in your listed medicine, provide:

  • the Australian Approved Name (AAN) for the ingredient
  • plant/animal part (where relevant), for example: herb, flower, rhizome
  • preparation (where relevant), include all extraction details:
    • number of extraction steps
    • solvent used
    • concentration
    • equivalent weights; and
    • any other relevant details.
    • For example: 'dried powder', '5:1 extract (in 25% ethanol) equivalent to 1g fresh leaf'.
  • equivalent dose of substance per unit dose, for example: 500 mg per dose; and
  • maximum recommended daily dose (MRDD), for example: 2 g per day.

1d: Listed medicine indication details

For each indication, you should assign a reference number (for evidence package) and record:

  • the indication (health benefit of the medicine). Where the indication is traditional, the indication should use terminology appropriate to the traditional medical paradigm
  • the active ingredient to which the indication relates to (as provided in 1c); and
  • indicate whether the indication is traditional or scientific.

For medicines with more than one active ingredient, evidence to support the indications can be for the formulated medicine or be derived for each individual active ingredient.

A single active ingredient medicine can have more than one indication, for example: a medicine formulated with a single active ingredient might have two indications attributed to it: 'decreasing nausea' and 'aids digestion.' You should hold evidence for each of the medicine's indications.

1e: Evidence package details

Use this table to confirm that your evidence package includes:

  • a completed cover page (checklist 1)
  • scientific and/or traditional evidence search strategy (checklist 2)
  • evidence filter for your traditional indication (checklist 3)
  • scientific filter for your scientific indication (checklist 4)
  • summary of evidence of traditional use for your traditional indication (checklist 5)
  • summary of scientific evidence for your scientific indication (checklist 6)
  • copies of supporting evidence for your indication (as listed in your evidence summary ) attached: and
  • an indication of the number of attachments and the total number of pages in the evidence package.

Next step

Complete checklist 2 to record your literature research.

Checklist 2: Evidence search strategy

You should undertake a literature search for your scientific or traditional indication. The Australian Regulatory Guide for Complementary Medicines (ARGCM) provides guidance on performing a literature search. It is recommended that the help of a specialist librarian is sought, particularly when searching non-English databases when conducting the literature review.

Use checklist 2 to document the outcomes of your search of all items of evidence associated with your medicine. You should complete a separate document for each indication for your medicine. Add as many rows to the table as you need to record all evidence sources identified. This information is important to demonstrate that you have conducted an objective, comprehensive, transparent and reproducible review of the literature relating to your indication.

The quality of evidence will determine the nature of any claim and the wording that can truthfully be used. You are encouraged to refer to credible online sources, such as other regulatory authorities and other reputable agencies. New and unpublished data may be relevant, but they must be assessed within the context of the existing published body of knowledge.

Selecting and combining terms is of fundamental importance in searching electronic databases. You should document the search terms (online and within books) and databases you use and the number of references retrieved.

As traditional indications refer to a tradition of use rather than efficacy, efficacy data is not required (such as clinical trials or studies). However, it is important that the terms used to refer to a health benefit in the evidence held are identical or equivalent to those used in an indication.

Include all references that you find: even those you may discard later because they are irrelevant or poor quality. In particular include those references which do not support your proposed indication to show that a balance of evidence approach has been considered. You may be required to provide a justification to the TGA as to why this evidence was considered irrelevant.

The search must extend retrospectively for at least 10 years from the present day. Searches should not be limited to English, but every effort must be made to obtain translations of key references. Non-English language literature will need to be considered if this is a source of significant scientific work. All publications appended to the final report must be in the English language, or be a certified English transcript from the native language

Search strategy

Provide the following information in the table provided:

  • Source searched:
    • identifying bibliographic details
    • exclude duplicate sources; and
    • include any website links.
  • Date range of search: applicable for scientific literature searches.
  • Search terms: include key words and specific exclusion terms.
  • Type of evidence: Indicate if the evidence is scientific (such as: random control trial, evidence based text, Cochrane review) or evidence of traditional use (traditional pharmacopoeia, material medica).
Example of entries in the search strategy table:
Search strategy for evidence package
Source searched Date range of search Search terms Type of evidence
Medline 01/01/2003-10/10/2012

Echinacea and common cold

NOT: influenza ,flu

Scientific: RCTs, non-clinical studies, mechanistic studies
British Herbal pharmacopoeia NA Echinacea species Traditional: monograph

Next step

The items of evidence that you have collated through this process should be filtered in checklist 3 (evidence of traditional use) or checklist 4 (scientific evidence). The filtering process will determine the relevance and quality of each evidence item. This should be completed for all items of evidence.

Top of page

Checklist 3: Evidence of traditional use filter

Use this checklist for traditional non-specific (general) and specific indications. Complete the checklist for each item of evidence.

Checklist 3 provides a filtering process to help you assess your item of evidence to determine:

  • that the evidence supports a tradition of use for your indication
  • the credibility of the item of evidence; and
  • the relevance of the evidence to your medicine/indication.

The filter assists you reduce the number of evidence items to those that are credible and relevant, or to those that you can justify their inclusion into your evidence summary.

If you wish to use evidence for several ingredients to support an indication, each ingredient should be supported by evidence that meets the majority of checklist 3a.

3a Filter for evidence of traditional use

Evidence item

Provide the details of the item of evidence that you are assessing.

Part 1: Tradition of use

This section of the checklist aims to establish if the evidence supports a history of traditional use (3 generations or 75 years) for your indication.

Your evidence of traditional use should refer to primary sources of evidence and you should check if they are adequately referenced. Some literature items cite, comment on or build on primary sources of evidence. If you use such an evidence item, you must locate the original or primary source of evidence of traditional use so as to establish primary references. That is, is find copies or quotations from the original documents cited in footnotes. If this is not possible then include the footnotes in your evidence summary to clearly indicate that the textbook is based on original historic records.

Where it is impossible to find the original reference that describes the traditional use, evidence of traditional use may be supported by more recent references reporting the original tradition. However, these references should provide enough information to support that your medicine is consistent, as far as possible, with the one described in the original reference.

Part 2: Filter for credibility of evidence

This section of the checklist establishes whether the evidence item is from a credible source, such as internationally recognised monographs and pharmacopoeias. The credibility of evidence of traditional use may vary with the nature of the reference source, and the degree of clarity of references to a health benefit.

Part 3: Filter for relevance of evidence

The available evidence should be directly relevant to the proposed indication and ingredient characteristics (such as plant part and dose). This section of the checklist asks you questions relating to specific concepts to determine the level of relevance of the item of evidence.

This will allow you to make an assessment on whether to include the item in your evidence summary.

You assess whether your item of evidence of traditional use is relevant by determining how similar it is to your medicine/indication. You determine this by answering by selecting either 'identical', 'similar', 'different' or 'unknown' to the questions for each piece of evidence you hold.

Indication

Your evidence should refer to the same specific health benefit (with the same meaning and intent) as your medicine.

If your indication is a specific traditional indication, the evidence should support this specific health benefit and context of use, for example: target population

Evidence of traditional use may be derived from populations that do not closely resemble the general Australian population (which is the target population for listed medicines in Australia). Further, some traditional medicine paradigms may specifically exclude certain subgroups of the populations from using a particular medicine (for example: children, pregnant women). Your indication should reflect this evidence

Active ingredient characterisation and traditional methods of formulation

The active ingredient should be clearly identified and characterised in the evidence, including:

  • name:
    • Latin binomial for herbal species; or
    • correct scientific name (including relevant salt) for minerals, vitamins or other non-herbal substances)
  • plant part; and
  • preparation and extraction method.

Route of administration

Dosage

The dose, dosage form, dosage range and dosage frequency of the ingredient/medicine should be consistent with your evidence and the composition and preparation of the medicine should be consistent with the principles of the tradition about which the indication is made.

Duration of use

How similar to your medicine is the duration of use specified in the evidence, for example: long term, short term?

Risks, cautions or contraindications

How similar to your medicine is the information regarding any risks, cautions or contraindications (including identification of no known risks, cautions or contraindications) in the evidence to those of your medicine?

For example: if the evidence refers to the ingredient being contraindicated for use in children, your medicine should also reflect this restriction in use.

Top of page

Assessment of evidence to support your indication

If you answer 'yes' and 'identical' to the majority of questions in checklist 3a, then your evidence item is likely to have a history of traditional use, be credible and relevant to your medicine. Such an item would be considered a primary source of evidence and can be used to support your indication.

If you answer 'no', 'similar' or 'different or not specified' to the majority of questions in checklist 3a, it is likely that the evidence does not support your indication and you should disregard it. If you choose to include this item of evidence in your evidence package you should provide justification as to why that item of evidence is included (see 3b).

3b Justification of evidence

It is recognised that it may be difficult to provide evidence for traditional indications that fulfil all aspects of the credibility and relevance criteria.

Some sources of evidence may not include sufficient details to meet the majority of the relevance and quality criteria in the traditional checklist filter (3a). In this situation, you should hold several sources of evidence that meet most of the relevance criteria in the traditional checklist and when these are combined, the collective source should provide all aspects of the evidence for all concepts raised in the filter. That is the combined items of evidence should address data gaps identified in 3a. This process allows you to use multiple sources of evidence of traditional use to accurately support your traditional indication.

If the evidence summary table lists evidence items that are not relevant (and no justification has been provided for their inclusion into your evidence summary), you may be asked for further clarification as to why you have included evidence that appears irrelevant.

Traditional ingredient changes

Traditional ingredients or medicines which have been altered significantly in their constituent profile from the classical traditional medicine on which the indication is based, further information may be required to justify the alteration in order to substantiate their claimed indication.

Next step

Once you have filtered your evidence to those references that are credible and relevant, or have a justification for their inclusion in your evidence summary, then these references should be included and summarised in Checklist 5: Summary table for evidence of traditional use.

Checklist 4 Scientific evidence filter

Checklist 4 has been provided to assist you with the decision on which items of evidence are relevant to your medicine and are of high-quality. Use this document to assess the relevance, quality and balance of your scientific evidence.

During your search for evidence you may come across many different types of evidence from a variety of different sources of literature and you must review the literature to collate high-quality evidence that is relevant to the indication or medicine - known as 'filtering'.

All indications based on scientific evidence must be supported by primary evidence, such as clinical studies. The scientific uncertainties involved in extrapolating human data from animal and In vitro studies limit their usefulness as an evidence base to support your indication. Non-human and In vitro studies may, however, be used to support any discussion on biological plausibility of a potential mode of action in humans.

Establishing the relevant evidence base for your proposed indication is a critical step in the review of evidence. This requires an assessment of the relevance of every item retrieved during the literature review to your proposed medicine, dose and indications. The relevant evidence base for your indication includes all studies that are relevant in terms (amongst others) of ingredient, health benefit, population and context of use.

Additionally, you will be able to determine which items of evidence can be classified as a primary source of evidence (either supporting or non-supporting of your indication), and which item should be relegated to a secondary source of evidence.

If your medicine has more than one indication, you should fill out a new version of checklist 4 for each indication.

Use the scientific evidence filter to reduce the number of evidence items to those that are relevant and of high-quality, or to those that you can justify their inclusion into your evidence summary.

You should also ensure that the evidence supporting your indications remains valid for the life of the medicine, and this is best achieved using a body of evidence approach. As research advances, the body of scientific evidence supporting a particular health benefit may change. Newer clinical studies may enhance the strength of the evidence supporting your claim, or it may be inconsistent with the strength of previous research. Having a body of supporting evidence will allow you to ensure that the indications claimed for your medicine remain true, valid, not misleading and consistent with scientific evidence for the life your medicine.

4a: Simplified filter for non-specific supplementation indication

Vitamin, mineral and nutrient supplementation is often supported by high-quality and credible scientific literature. Use this simplified checklist if your medicine provides a vitamin, mineral or nutrient and the indication refers to general health and wellbeing and does not claim a specific health benefit.

Evidence item

Provide the details of the item of evidence that you are assessing.

Part 1: Filter for credibility of evidence

The questions in this part aim to establish that your evidence item is from a well-recognised and credible source.

Part 2: Filter for relevance of evidence

This part establishes that you have the same ingredient as in the evidence, it is absorbable by the body and the medicine provides and 25% of the Recommended Daily Intake (RDI).

Assessment of evidence item

If you answered yes to the majority of questions above and have 2 sources of primary evidence, it is likely your indication will be supported by the evidence.

4b: Scientific evidence filter: relevance and quality

This section assists you determine which items of evidence in your evidence summary are relevant to your medicine and assess the quality of evidence that are relevant.

Provide details of the item of evidence at the top of the table

Evidence item

Provide the details of the item of evidence that you are assessing.

Part 1: Relevance of the evidence source to the indication.

The checklist includes questions to allow you to assess whether the item of evidence is relevant to your medicine. You assess whether your item of evidence of traditional use is relevant by determining how similar it is to your medicine/indication. You determine this by answering by selecting either 'identical', 'similar', 'different' or 'unknown' to the questions for each piece of evidence you hold.

Indication

You must ensure that the research is relevant to your proposed specific indication for your medicine. In drafting indications, you should take care to make sure that they match the underlying evidence you hold. Indications that do not match the science, no matter how sound that science is, are unlikely to be supported. Indications should not exaggerate the extent, nature, or prominence of the effects achieved in a study (the study outcomes), and should not suggest greater scientific certainty than that which actually exists.

Specificity

Your evidence should refer to the same specific health benefit (with the same meaning and intent) as your medicine.

If your indication is a specific traditional indication, the evidence should support this specific health benefit and context of use, for example: target population

Active ingredient characterisation

The active ingredient should be clearly identified and characterised in the evidence, including such things as plant part, preparation and extraction method.

For specific scientific indications, the different formulation between your medicine and that of the formulation reported in the scientific evidence is very important (for example: the use of a novel tablet matrix). If there are differences noted, then further justifications will be required to address the data gaps identified using the checklists provided.

Active ingredient name

The evidence must be relevant to the ingredient name used in your medicine, such as the:

  • Latin binomial for herbal species; or
  • correct scientific name (including relevant salt) for minerals, vitamins or other non-herbal substances).
Dosage

For scientific indications, the recommended dosage and duration or frequency of administration of the medicine must be consistent with the evidence supporting the indication.

Route of administration

The evidence must relate to the whole medicine, the same active constituent(s) with a similar route of administration to the medicine for which a claim is being made.

Duration of use

The recommended duration of use for your medicine should reflect the evidence.

Risks, cautions and contraindications

Your medicine should restrict us to any risks, cautions or contraindications included in the evidence.

Part 2b: Quality of the evidence item

In addition to determining the relevance of the item of evidence, you need to determine whether the evidence is of high quality, as the quality of evidence is important. Only items of evidence that are relevant to your medicine need to be filtered in this part of the scientific filter. ]

Clearly stated hypothesis

The item of evidence should clearly state the hypothesis or purpose of the study/research.

Study methodology

The clinical research being used to support your scientific indication should be conducted in a reliable manner to yield meaningful and reproducible results. The design, implementation, and results of each piece of research are important to assessing the adequacy of the substantiation of the health benefit or study outcome.

There are some principles generally accepted in the scientific community to enhance the validity of test results. However, there is no single set protocol for how to conduct research. For example, a study that is carefully controlled, with blinding of subjects and researchers, is likely to yield more reliable results. A study of longer duration can provide better evidence that the claimed effect will persist and better evidence to identify potential safety concerns.

You should critically appraise scientific studies in terms of methodological quality and the possibility of bias and/or confounding. Studies that have been peer-reviewed are more likely to be methodologically robust, but may not be.

Filtering to relevant evidence to those of high quality will involve, as a minimum, an assessment of the following:

  • characterisation of the ingredient/s
  • study design/methods
  • participant eligibility (inclusion/exclusion criteria)
  • adequacy of randomisation and blinding of participants (for example Randomised Controlled Trials (RCT))
  • sample size justification
  • controlling for potential confounders
  • study attrition (for RCT and cohort studies); and
  • statistical analyses undertaken.

For each study, the meaningfulness of the observed effect/s to consumers at an individual and/or population level (clinical significance) must be assessed.

Participants enrolled in studies used to justify indications for your listed medicine should fit the following eligibility criteria, unless your medicine is directed to a specific population sub-group:

  • male and female participants
  • generally healthy
  • aged 18-65 years; and
  • socioculturally similar to the Australian population.

Secondary evidence or non-clinical studies (such as mechanistic studies) are normally insufficient to support indications implying efficacy. However, secondary evidence may be used in conjunction with primary evidence to strengthen the wording of an indication.

Participant dropouts

Attrition rates are commonly high in studies that evaluate health gains that are modest and require long-term commitment. High attrition can introduce serious bias (attrition bias) into these studies because the reasons for non-completion vary across initially randomised groups. High attrition rates may also diminish the general applicability of the treatment to the Australian population. The resulting data from a high attrition study should be interpreted with caution.

Confounders

Do any of the study's confounders or variable affect the relevance of the evidence to your indication?

Method of randomisation

Studies that incorporate randomisation process of assigning trial subjects to treatment or control groups are often considered of greater quality due the reduction of potential for bias. The randomisation method should be described in the study report and meet contemporary standards (such as using post-study questionnaires' of study participants to confirm that they remained blinded). Similarly, the incorporation of good blinding methods in the study design tends to result in studies that are methodologically robust.

Blinding protocol

Blinding protocols aim to avoid bias. A double blind protocol is where neither the experimenter nor experimental subjects have knowledge of the identity of the treatments or the results until after the experiment is complete.

Statistical analysis

Statistical significance of study outcomes is important. A study that fails to show a statistically significant difference between test and control group may indicate that the measured effects are merely the result of a placebo effect or chance. The results should translate into a meaningful benefit for consumers. Some results that are statistically significant may still be so small that they may not provide a positive effect to consumer health.

Study limitations

You need to consider if any study limitation affect the relevance of the evidence to your indication.

Clinical significance

You should assess the results of scientific studies for statistical significance and meaningfulness (clinical significance) of the reported therapeutic benefit. Your evidence should demonstrate an overall improvement in the expected health benefit that is statistically and clinically significant.

Assessment of evidence to support your scientific indication

If you have answered yes or identical to the majority of questions it is likely that the item of evidence is relevant and of high quality and supports your indication.

Items that are considered to be of low quality should be disregarded unless you can provide a justification (refer to 4d) for its inclusion into your evidence summary as a secondary source of evidence.

Top of page

4c: Balanced view of evidence

Part 4c assists you in make a balanced assessment of the evidence, which is an important criterion in evaluating the validity of your package is whether your evidence package represents a balanced view of the currently available body of evidence.

Before you list a medicine on the ARTG you must be satisfied that the balance of evidence supports your indication. In other words, a reasonable person making an objective assessment of all the relevant, high-quality evidence about your medicine would conclude that the weight of good evidence is in favour of your indication rather than against it. Your indications must not, indirectly, or by implication, lead consumers to believe that your medicine will assist in a health benefit that is not explicitly supported by the balance of evidence.

Studies cannot be evaluated in isolation of the surrounding context. The surrounding context of the scientific evidence is just as important as the internal validity of individual studies. You need to consider all relevant research relating to the claimed benefit of your medicine and should not focus only on research that supports the effect, while discounting research that does not. A well-constructed literature search should normally be undertaken to help ensure that the general body of evidence related to a specific indication is identified.

Your evidence should rely on studies that are largely consistent with the surrounding body of evidence. Where there are inconsistencies in the evidence, it is important that you examine whether there is a plausible explanation for those inconsistencies. In some instances, for example, the differences in results will be attributable to differences in dosage, the form of administration, the population tested, or other aspects of study methodology. You should assess how relevant each piece of research is to the specific indication you wish to make, and also consider the relative strengths and weaknesses of each. If a number of studies of different quality have been conducted on a specific topic, you should look first to the results of the studies with more reliable methodologies (that is, RCTs or systematic reviews).

To facilitate the assessment of balance view of evidence, both relevant non-supporting and supporting items of evidence will need to be assessed for quality.

Checklist 4c provides a mechanism to determine the number of high-quality items that are relevant to your medicine. You will need to have regard to irrelevant studies noted during the search of the available literature to make an assessment of the balance of evidence for supporting your indication. Only if the balance of high quality evidence is equivocal are the outcomes of lower quality studies to be included in assessing the balance of evidence.

This checklist is designed to help you assess whether a reasonable person making an objective assessment of all the relevant, high-quality evidence about your medicine would conclude that the weight of high-quality evidence is in favour of your indication rather than against it.

When the balance of scientific evidence supports your proposed indication then complete the Scientific Evidence summary. Otherwise, you should reconsider your indication and modify the indication such that it is consistent with the evidence that you hold.

4d: Justification of evidence

If you choose to include a piece of evidence in your evidence summary that is not relevant, of high quality or reflective of the balance of evidence, you should provide justification for doing so. Otherwise you may choose to reconsider the wording (or strength/specificity) of your indication and evaluate the evidence for a modified indication.

If your evidence does not include certain details (for example: frequency of dose or dosage form) you should provide justification for the inclusion of these specific details on your medicine and this may be derived from another item of evidence.

Justification can consist of written explanations, documents and supportive evidence.

Next step

Once you have filtered your evidence to those references that are credible and relevant, or have a justification for their inclusion in your evidence summary, then these references should be included and summarised in Checklist 6: Summary table for evidence of scientific use.

Top of page

Checklist 5: Evidence of traditional use summary

Use this document to summarise your evidence items that when considered together support your traditional indication (combined collection of evidence). You should only need to complete this summary document once for all indications related to your medicine.

5a: Reference list for indications

Provide the indications as listed in checklist 1; Evidence package cover page, part 1d.

5b: Reference list for items of evidence

Enter full citation details of the evidence into the table, and then use the corresponding 'Evidence reference number' to add detail on each of these references to the table in 5c.

You should record the following, where relevant, for each item of evidence you find in the summary of evidence of traditional use table:

  • the bibliographic details
  • author name
  • article title
  • journal title
  • journal volume/issue number
  • month and year of publication; and
  • page numbers.

5c: Evidence summary for traditional indications

Use this section to summarise the findings and how they relate to your medicine. Ensure that the reason for including each item of evidence is clear from the information included in the list. If aspects of the evidence such as dosages, preparation types, indications or patient populations differ from those applicable to your medicine, include the justification of the relevance of the evidence in the 'Summary of findings' column.

You should attach a copy of each item of evidence to the checklist that applies to it, and make sure you note the correct publication details.

Examples of the type of the types of evidence included in the summary for a traditional indication include:

  • copies of primary sources of information, for example: the relevant pages of a recognised pharmacopoeia such as the British Herbal Pharmacopoeia
  • verified translations of those pages if the sources are in languages other than English
  • video footage (digital format, not on film) or transcripts of any video footage being used as evidence; and
  • any additional information to support justifications for inclusion of evidence items.

Top of page

Checklist 6: Evidence summary for scientific indications

The evidence summary table is what the whole evidence-filtering process leads up to. Checklist 6 includes all the required summary information for your listed scientific indication.

If the evidence summary table lists items of evidence that are not relevant or includes poor quality studies (without providing justification for their inclusion into your evidence summary), the TGA may ask for further clarification as to why you have included evidence that appears irrelevant.

Does the Evidence summary table only include relevant, high quality evidence?

If not, then you will need to provide justifications as to why you have included these items in your evidence summary.

6a: Reference list for indications

Provide the indications as listed in checklist 1; Evidence package cover page, part 1d.

6b: Reference list for items of scientific evidence

Enter full citation details of the evidence into the table, and then use the corresponding 'Evidence reference number' to add detail on each of these references to the table in 6c.

You should record the following, where relevant, for each item of evidence you find in the summary of evidence of traditional use table:

  • author name
  • article title
  • journal title
  • journal volume/issue number
  • month and year of publication; and
  • page numbers.

6c: Evidence summary for scientific indications

Use this checklist to assist you to summarise your evidence and justify how it supports the scientific indications you claim for your medicine. You will take the items of evidence from checklist 4 which have been classified as supporting and summarise these in checklist 6.

You should attach a copy of each item of evidence and any additional information (for example: to support justifications for inclusion of evidence items) to your evidence package.

Book pagination