There is a list of diseases/disorders about which claims may be made only after evaluation of the product and the claim(s) through Registration of the product. The list refers to serious diseases/disorders and it applies to claims based on evidence of traditional use, as well as to those based on scientific evidence. The list is known as the “Registrable disease” list and it applies to medicines but not devices. Decisions made with respect to the Registration of medical devices are based on a different set of categorisations and guidelines.
The definition of a serious disease or disorder is one for which there is a substantial body of medical opinion that the disease cannot or should not be diagnosed or treated except under medical advice.
Claims for Registrable diseases may be made under certain circumstances, but only after the safety, quality and efficacy of the product and the claim(s), have been evaluated by the CMEC or other relevant evaluation committee. Where a sponsor seeks to mention a Registrable disease in what would otherwise have been categorised as a medium or general level claim, that claim would become Registrable and the product would require Registration (that is, evaluation by the TGA with the advice of the CMEC, MEC, or ADEC). The “Registrable disease” list is shown in Table 3.
Table 3. The Registrable disease list (for medicines)
Disease/disorder/action - serious manifestation of |
Abortifacient action. |
Cardiovascular diseases but not: |
|
• the use of devices to measure parameters or control circulation locally; or |
|
• reference to assistance of peripheral circulation. |
Dental and periodontal disease but not |
|
• dental caries. |
Diseases of joint, bone, collagen, and rheumatic disease, but not |
|
• relief of symptoms; |
|
• osteoarthritis, or |
|
• calcium for the prevention of osteoporosis. |
Diseases of the eye or ear likely to lead to severe impairment, blindness or deafness. |
Diseases of the liver, biliary system or pancreas, but not: |
|
• liver tonic or liver formula. |
Endocrine diseases and conditions, including diabetes and prostatic disease, but not: |
|
• pregnancy testing. |
Gastrointestinal diseases or disorders, but not |
|
• relief of symptoms. |
Haematological disorders and diseases. |
Immune disorders and diseases. |
Other: |
Immunisation |
Infectious diseases, including sexually transmitted diseases, but not: |
|
• symptomatic relief of upper respiratory tract infections; |
|
• management of cold sores; |
|
• the use of condoms to prevent transmission during sexual intercourse; or |
|
• topical treatment for non genital warts. |
Insomnia, persistent. |
Mental diseases, ailments or defects, including substance abuse. |
Metabolic disorders. |
Musculoskeletal diseases. |
Neoplastic disease (all cancers). |
Nervous system diseases, but not |
|
• folate for neural tube defects. |
Renal diseases and diseases of the genito-urinary tract. |
Respiratory diseases, but not: |
|
• symptomatic relief of upper respiratory tract infections. |
Skin diseases, other than relief of symptoms by topical treatment, with a warning not to use for long periods without medical advice. Sunscreens may however, carry claims relating to the prevention of skin cancer and skin damage. |
Poisoning, venomous bites and stings - treatment of. |
The CMEC is in the process of developing a guideline to support the interpretation of the Registrable diseases list. The guideline identifies those diseases/disorders that may be mentioned in claims on Listed goods, and therefore claims relating to these diseases/disorders do not, in general, require Registration. TGA advice may be sought where sponsors are in doubt about diseases/disorders that are not included in either list. The first draft of such a guideline (The Listable disease list) is at Attachment 4 to this document.
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