Next generation probiotics (NGP) or live biotherapeutics are organisms that have been designed to be used as living medicines to treat, cure or diagnose disease. They differ from traditional probiotics in that they are likely to be registered under a drug regulatory framework. At present, conventional probiotics are used as either functional foods or as supplements, whereas NGPs are mainly used as therapeutics and hence are subject to the full range of registration processes and clinical trials.

This article describes the issues and regulatory processes in the development and registration of next-generation probiotics, and their potential for application in aquaculture.