Guidelines for levels and kinds of evidence to support indications and claims
Guidelines
These guidelines have been developed to assist sponsors in determining the appropriate evidence to support indications and claims made in relation to Listable medicines. In particular, they relate to complementary medicines, sunscreens and other Listable medicines.
Guidelines for levels and kinds of evidence to support indications and claims (pdf,140kb)
The Therapeutic Goods Act 1989 requires that at the time of Listing, sponsors must certify that they hold information or evidence to support any claim that the applicant makes relating to the medicine. All indications and claims made about therapeutic goods must be capable of substantiation - that is, evidence must be held by sponsors which demonstrates the indications and claims are true, valid and not misleading.
Sponsors should also make reference to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) <http://www.tga.gov.au/docs/html/argcm.htm> which contain further advice in relation to the evidence requirements to support the indications and claims for Listable medicines. Specifically, ARGCM Part II - Listed Complementary Medicines <http://www.tga.gov.au/docs/html/argcm.htm#argcmp2>, Section 6.2.2.
In addition, ARGCM Part I - Registration of Complementary Medicines <http://www.tga.gov.au/docs/html/argcm.htm#argcmp1>, Sections 4.1.3 and 7.3 includes the following advice for sponsors in relation to the Registration of complementary medicines:
The Guidelines on levels and kinds of evidence to support claims on therapeutic goods offers advice on the level (general, medium and high) of an indication or claim and the evidence required to support it. Registered medicines can carry claims of any level, provided the TGA has evaluated the evidence to support the indication(s) and approved the indication(s) for the Registered medicine.
Contents
- Executive summary
- How to make indications/claims based on evidence of traditional use
- How to make indications/claims based on scientific evidence
- Introduction
- The therapeutic goods regulatory system
- Levels and kinds of evidence to support claims
- The kinds of evidence which may support claims
- What kinds of indications and claims does the evidence support?
- Registrable diseases list
- In conclusion
- Glossary of terms used in these guidelines
- Definitions - types of claims
- TGA-approved texts
Evidence summary table for Listed medicines
The TGA undertakes post market reviews of medicines Listed in the Australian Register of Therapeutic Goods via the Electronic Listing Facility whereby approximately 25% of medicines are randomly selected for a review of their labels, product specifications and summary of evidence held by the sponsor to support the claims/indications made for the medicines. In order to ensure consistency in both formatting and content of the summary of the evidence provided by different sponsors, the TGA recommends that the sponsors summarise their evidence as shown in the following table. The information presented in the summary table is used by the TGA for the purpose of assessing whether the supporting evidence and the claims/indications are consistent with the Guidelines for the Levels and Kinds of Evidence to Support Claims and Indications for Listed Medicines. Where the claims/indications do not appear to be consistent with the evidence guidelines, the TGA may request the sponsors to submit full text copies of all relevant reference materials for evaluation.