Sponsors of herbal medicines may continue to "make claims about herbal components on their medicine labels without pre-market evaluation by the TGA as long as they are not confusing or scientifically incorrect" the Therapeutic Goods Administration (TGA) has stated following its consultation on the subject.
Including one from Complementary Medicines Australia, the TGA received only seven submissions on the subject, the majority of which supported the option of industry and the TGA working together to produce a workable mechanism that allows for the discontinuation of pre-market evaluation of herbal component names (HCNs) applications.
The TGA's position is that the pre-market evaluation of such low-risk products "was not commensurate with a risk-based approach to the regulation of complementary medicines".
Given that the evaluations were never cost-recovered, this was an expensive piece of unnecessary red tape that was costly to the tax-payer and a frustratingly lengthy and unpredictable hurdle for industry sponsors.
Accordingly, effective immediately the TGA is no longer accepting new HCN applications, with existing HCN forms and links on the agency's website to be archived.
Relevant guidance documents will also be updated, while IT system changes will deactivate existing non-mandatory HCNs in the Ingredients Repository.
The above article was sent to subscribers in Pharmacy Daily's issue from 28 Aug 18
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 28 Aug 18
