Following targeted consultation work through the ComTech committee, the TGA has now released their document “Guidelines for the Quality of Listed Probiotic Medicines” for public consultation. This consultation period will run from 24 July 2023 to 10 September 2023. The Draft Guidelines are available for review and comment here.
The purpose of these Guidelines is to help sponsors and manufacturers meet the technical, scientific and regulatory requirements to ensure the quality of their probiotic medicine is acceptable under the Therapeutic Goods Act 1989.
These Guidelines apply to probiotic medicines that are listed on the Australian Register of Therapeutic Goods (ARTG), including Listed and Listed (Assessed) medicines.
Consultation closes on 10 September 2023, so be sure to provide the TGA with your feedback before then. If you would like to know how these new Guidelines (or other new Guidelines that the TGA has provided) apply to your products, please contact us.