In cases where the traditional terminology may be unclear to consumers, the information should (also) be communicated using appropriate conventional terminology. The use of appropriate contextual qualifiers and the inclusion of a statement to the effect that the health benefit is based exclusively on long-term use and experience, ensures that such information is readily available to consumers. In situations where the requirements for both scientific evidence and evidence of traditional use are met for an active ingredient or product, traditional and/or scientific indications may be made. If an indication is solely supported by scientific evidence, it must not use the words used’. ‘traditionally The guidance regarding the assessment of evidence for scientific and traditional indications is provided in Section 3. 2.2 Types of indication according to type of health benefit Listable indications may be further classified according to type of health benefit. In broad terms, indications may target biological factors or processes, health states or clinical conditions. The following diagram provides a schematic representation of all states of health through healthy to symptomatic illness. It also includes a description of the different types of indications according to the action or effect on the indication target. Indications can be conveniently separated into three clusters indications targeting: a – generally healthy state; risk reduction/prevention; and illness. All indications must be supported by evidence that is appropriate and valid. Figure 1: Schematic diagram showing relationships of different types of indications Cluster 1: Health indications Health indications target healthy individuals and assist in maintaining or improving their state of health and wellbeing. The health indication cluster includes the following types of indications: health maintenance: normal physiological effects of nutrients and trial substances in growth, development and normal functions of the body. health enhancement: specific beneficial effects of nutrients and other substances on physiological and psychological activities beyond their role in normal growth, development and normal functions of the body. Cluster 2: Risk reduction and prevention indications Risk reduction/prevention indications target individuals at risk of illness and partially or completely reduce the risk. The risk reduction/prevention indication cluster includes the following types of indications: risk reduction: favourable modification of a known risk factor for a specified illness. condition, disease or disorder. prevention: prevents the development of a named illness.
In cases where the traditional terminology may be unclear to consumers, the information should (also) be communicated using appropriate conventional terminology. The use of appropriate contextual qualifiers and the inclusion of a statement to the effect that the health benefit is based exclusively on long-term use and experience, ensures that such information is readily available to consumers. In situations where the requirements for both scientific evidence and evidence of traditional use are met for an active ingredient or product, traditional and/or scientific indications may be made. If an indication is solely supported by scientific evidence, it must not use the words ‘traditionally used’. The guidance regarding the assessment of evidence for scientific and traditional indications is provided in Section 3. 2.2 Types of indication according to type of health benefit Listable indications may be further classified according to type of health benefit. In broad terms, indications may target biological factors or processes, health states or clinical conditions. The following diagram provides a schematic representation of all states of health through healthy to symptomatic illness. It also includes a description of the different types of indications according to the action or effect on the indication target. Indications can be conveniently separated into three clusters – indications targeting: a generally healthy state; risk reduction/prevention; and illness. All indications must be supported by evidence that is appropriate and valid. Figure 1: Schematic diagram showing relationships of different types of indications Cluster 1: Health indications Health indications target healthy individuals and assist in maintaining or improving their state of health and wellbeing. The health indication cluster includes the following types of indications: health maintenance: normal physiological effects of nutrients and substances in growth, development and normal functions of the body. health enhancement: specific beneficial effects of nutrients and other substances on physiological and psychological activities beyond their role in normal growth, development and normal functions of the body. Cluster 2: Risk reduction and prevention indications Risk reduction/prevention indications target individuals at risk of illness and partially or completely reduce the risk. The risk reduction/prevention indication cluster includes the following types of indications: risk reduction: favourable modification of a known risk factor for a specified illness. condition, disease or disorder. prevention: prevents the development of a named illness. trial
consult-cm-evidence-listed-medicines-120827-a.docx