Proposed New Guidelines for the Quality of Listed Probiotic Medicines

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines (the Guidelines)’.

Probiotics are defined as live microorganisms that when administered in adequate amounts, are proposed to confer a health benefit on the host. The quality requirements for listed probiotic medicines are complex to piece together. The purpose of these Guidelines is to help sponsors and manufacturers meet the regulatory requirements to ensure the quality of their probiotic medicine is acceptable under the Therapeutic Goods Act 1989 (the Act).

Where these Guidelines provide interpretations of legislation, these are not mandatory requirements but provides transparency to industry by showing sponsors what a TGA delegate considers when assessing the quality of listed and assessed listed probiotics in a compliance review. Additionally, these Guidelines are intended to assist with sponsor and manufacturer compliance by naming and explaining the most relevant applicable legislation related to ensuring the quality of probiotic medicines. 

The purpose of this consultation is to seek stakeholder feedback on the clarity and presentation of information in these guidelines. This feedback will be used to improve the way complex information is communicated as well as the overall readability of the guidelines.

Proposed Guidelines

Draft Guidelines for the Quality of Listed Probiotic Medicines

Why your views matter

The TGA is requesting feedback to help refine the proposed new Guidelines.