The TGA undertakes post-market reviews for the safety, quality, and efficacy of listed medicines. These reviews may be random or targeted.
The TGA has updated its listed medicines compliance priorities for 2023. These are:
- Efficacy of listed medicines for exercise performance
- Efficacy of Lysine Hydrochloride containing medicines for cold sores
- Listed medicines containing caffeine
- Listed medicines at risk of containing safrole
- Efficacy of medicines containing Vitamin D that use indications relating to bone
Sponsors who have medicines which fall into one of these categories should review their products and ensure that they are compliant with the TGA’s regulatory framework. In particular, we recommend that you ensure that all of the indications listed in the Australian Register of Therapeutic Goods for your medicines are supported by sufficient evidence. If you are not sure if your products meet the expected standard, get in touch! We’re always happy to review your existing evidence package or prepare a new one for you.