Regulation of Probiotics and Postbiotics

Please see below for information on the CMA /TGA Probiotics Day at Lipa Pharmaceuticals, held in October 2022.

Today’s alert for technical members provides key information for members who are involved with applications for new microorganisms in listed medicines, which are whole cell or intact – these may be probiotics (live) or postbiotics (non-viable). It also applies to the development of new listed assessed or registered medicines based on these microorganisms. A 5 page Appendix describing TGA feedback on extensive consultation with CMA on new substance microorganisms is included.

In addition, the alert contains some clarifying information for members regarding postbiotics for existing microorganisms in the Permissible Ingredients Determination, based on CMA-TGA discussion.

Member update: CMA/TGA Probiotics Day at Lipa Pharmaceuticals

CMA are pleased to report the success of the CMA/TGA meeting and facility tour, as part of a probiotics discussion day, held at Lipa Pharmaceuticals on 24 October 2022.

CMA led a delegation of industry members and TGA staff, including TGA Manufacturing Quality Branch GMP inspectors and Complementary Medicine and OTC Branch staff, to attend a member manufacturing facility. The visit included a tour of the facility and information in relation to storage, testing, validation, blending uniformity and stability. The delegation also engaged in robust discussions on critical quality topics ensuring market continuance of important products, and aspects of methods of enumeration, acceptance limits, species and genus specific enumeration, overages and multi-strain products.

This meeting saw positive and constructive discussion between the group, and provided the opportunity to hear information and perspectives from the TGA and industry on how to best regulate the probiotics process from a finished product quality and legislative / regulatory and global leading perspective. The TGA are considering producing further guidance for the quality of finished probiotics that is likely to be released during 2023.

This event assisted in bridging the gap in understanding between the TGA and industry, and contributed to building a positive relationship with the regulator on challenging areas of technical regulation. The meeting was seen to facilitate renewed TGA connections with a view to enhancing a greater understanding of industry expertise and practices.

CMA thanks Lipa and other attending regulatory professional members for their invaluable contribution.



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