While the consultation is open you can make a submission at our TGA consultation hub.
We review the submissions carefully. After that the submissions and our decision will be available on the same page at the TGA consultation hub.
Overview
Interim decisions regarding substances discussed at the expert advisory meetings.
The Therapeutic Goods Administration (TGA) is conducting a public consultation and seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines. The proposals address the following issues:
- Curcuma species and curcumin and the risk of liver injury
- Green tea extract and the risk of liver injury
- Safe levels of benzophenone
- Clarification of the requirements for Soy phosphatidylserine-enriched ingredients
- Clarification of the requirements for Terminalia ferdinandiana
These ingredients are included in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). This is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989. This instrument specifies all of the ingredients that are available for use in listed medicines and the requirements for their use. The Determination is continually reviewed by the TGA to ensure that all ingredients are safe for use in low-risk medicines.
Timetable
The consultation opens on Thursday 3 August 2023. Interested parties must respond by close of business Thursday 14 September 2023.
Please see the Schedule for annual low-negligible risk changes.
Enquiries
For enquiries relating to the consultation document or your submission please email listed.medicines@health.gov.au.
All current TGA consultations can be found at the TGA consultation hub.