General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Open this folder and view contents4. Other Issues and Considerations
View the documentReferences
Open this folder and view contentsAnnexes
Open this folder and view contentsAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Open this folder and view contentsAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Close this folderAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
View the documentClaims Based on Evidence of Traditional Use
View the documentWhat Kinds of Claims Does the Evidence Support?
View the documentRegistrable Diseases List
View the documentClaims Based on Evidence of Traditional Use
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

What Kinds of Claims Does the Evidence Support?

As described earlier in these guidelines there are two types of evidence which can be used to support claims on therapeutic goods. These are scientific evidence and evidence based on traditional use of a product or substance.

Claims based on scientific evidence

There are various types of claims based on scientific evidence that can be made; they are generally categorised according to the type of information they convey. Additionally, claims can be ranked in relation to the relative strength of the claim and their likely impact on consumers. These rankings provide a basis for the level of scientific evidence which may be required to support each type of claim.

In Australia, claims that may be made about therapeutic goods are categorised into three levels - high, medium and general. Different levels of evidence are required to support each level of claim. Within these three levels there are several different types of claims that may be made. For simplicity, this approach can be summarised as shown in Table 2. A summary of the definitions of the types of claims is provided at Attachment 1 to these guidelines.

Table 2. Levels and types of claims and the evidence required to support them - based on scientific evidence

Level of claim

Type of claim

Evidence required to support claim

HIGH1

• Treats/cures/manages any disease/disorder.
• Prevention of any disease or disorder.
• Treatment of vitamin or mineral deficiency diseases.

High level. Registration only - evaluated by the CMEC, MEC (Medicines Evaluation Committee) or the ADEC (Australian Drug Evaluation Committee).

MEDIUM

• Health enhancement2.
• Reduction of risk of a disease/disorder.
• Reduction in frequency of a discrete event.
• Aids/assists in the management of a named symptom/disease/disorder.
• Relief of symptoms of a named disease or disorder3.

Medium level. Sponsor must hold the evidence for Listable goods.

GENERAL

• Health maintenance, including nutritional support.
• Vitamin or mineral supplementation4.
• Relief of symptoms (not related to a disease or disorder)3.

General level. Sponsor must hold the evidence for Listable goods.

Notes:

1 There are some specific exemptions to this table which are not considered to be high level claims. These are shown in Attachment 2 to these guidelines.

2 Health enhancement claims apply to enhancement of normal health. They do not relate to enhancement of health from a compromised state.

3 All claims relating to symptoms must be accompanied by the advice “If symptoms persist consult your healthcare practitioner”.

4 Vitamin or mineral supplementation claims are only permitted where the recommended daily dose of the product provides at least 25 percent of the Recommended Dietary Intake (RDI) for that vitamin or mineral. Where vitamins or minerals are the subject of other kinds of claims, the dose must be consistent with the evidence to support the claim being made. Claims should not refer to the presence of vitamins or minerals unless they are present in the recommended daily dose of the product to at least the level of 10% of the RDI, unless there is evidence to support a therapeutic effect below this level.

There is a wide variety of references, research papers and texts which may be used as sources of evidence to support these claims. No list of acceptable references can be exhaustive, but some broad guidance for sponsors is offered in Attachment 3 to these guidelines. The absence of a reference from this list does not necessarily mean the reference is unsuitable for inclusion.

Sponsors should make sure that the research on which they rely is relevant to the specific product being promoted and to the specific benefit being claimed. Further guidance for Registrable products is available in the Australian Guidelines for the Registration of Drugs (volume 2) for OTC products, and for complementary medicines, the Australian Guidelines for Complementary Medicines (currently in draft form).

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