Evidence to support indications for listed medicines

The NHAA did not do a submission to the TGA on this issue for a number of reasons. Some members also expressed concerns that this will lead to a similar situation as has been experienced in the UK and America.


The reasons for not putting in a submission are:

  1. We had trusted representation on the original advisory committee that compiled the draft.
  2. We were given very little time to do a thorough assessment (a complaint many others made), and as a volunteer board this was a bigger issue than for a company whom could allocate an employee to the task)
  3. While we could certainly see some issues with the first draft (mainly in format), we basically agreed with the new requirements, so elected to await the revisions before making a decision on making further comment.

Assessing the draft, important elements of the changes to evidence requirements for manufacturers have been reviewed by the NHAA. These include;

  1. The continued recognition of “Traditional Evidence”.
  2. Improved compliance for manufacturers in meeting evidence requirements.
  3. Recognition of Herbalists and Naturopaths as experts in compiling evidence for TGA evidence submissions.
  4. Clearer labeling requirements for OTC products

With regards to comparisons to the regulatory situation in the UK and Europe, this is quite different. As mentioned in the draft the most compelling reason for this review by the TGA was the large % of sponsors who were non compliant with existing evidence requirements. The changes will hopefully improve the quality of OTC products and reduce fraudulent claims on product labeling.