TGA New Substance Applications (Listed Medicines)
Listed medicines in Australia are low risk medicines such as many vitamin herbal and mineral supplements. Listed medicines must only contain TGA pre-approved low-risk ingredients (actives and excipients). Pre-approved ingredients are listed in the Therapeutic Goods (Permissible Ingredients) Determination. Listed medicines must also only refer to low-risk pre-approved TGA indications, more on that below. The TGA evaluates both the quality (e.g. manufacture, specification, analytical methods) and safety of the substance.
Enimera RegsPlus can help get your chemical, botanical or animal-derived substance on the TGA pre-approved ingredient list so it can be used in listed medicines. Contact Enimera RegsPlus to learn more.
TGA Listed-Assessed Medicines
One of the key differences between TGA listed-assessed medicines and TGA listed medicines is that the indication(s) listed-assessed medicines deviate from the listed medicine pre-approved indications – they are relatively stronger indications. Given this, TGA listed-assessed medicines are evaluated for efficacy by the TGA.
Enimera RegsPlus can help with clinical trial design and preparation of the TGA application for your listed-assessed medicine.
Interested in learning more about new listed medicine substances or listed assessed medicines?
The first step is often a gap and option analysis in a feasibility assessment to understand TGA data requirements, TGA process, and key risks. Contact Enimera RegsPlus to understand how we can help.
