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
 

Registrable Diseases List

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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