TGA Consultation: Pre-market approval of HCNs

Avicenna Consulting has made a submission to the TGA consultation on pre-market approval of HCNs (or herbal component names).

We have suggested that the current pre-market approval of HCNs does not align with the boarder regulatory framework for listed medicines, which requires evidence to be reviewed in a post-market setting. However; we support the continued use of HCNs to allow sponsors and consumers to differentiate between products.

We have also raised a number of issues regarding the provision of guidelines for industry, the management of existing ingredients, and the potential for non-compliance of a small group of sponsors.

Click here to read the full submission or click here to learn more about our services.