The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
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 (the Act).
Note: This document is a guide only
- These Guidelines are not mandatory requirements but rather show sponsors what a TGA delegate considers in a compliance review. However, there may be individual circumstances that justify a departure from these Guidelines and in any circumstance the TGA will consider the merits of each case against the regulatory requirements.
- Providing transparent and clear guidance on the elements considered by a TGA delegate in a compliance review is good regulatory practice and aims to mitigate the risk of non-compliance.
- It is the responsibility of each sponsor to understand and comply with the regulatory requirements contained in the Therapeutic Goods Act 1989 (the Act) and supporting regulations. You are encouraged to seek your own professional advice on how therapeutic goods legislation and other applicable laws apply to you.