The recent rise of science in the microbiome field has brought to light new opportunities of health technologies development. Microbiome-derived products are very diverse and encompass several product categories such as foods as well as medicinal products. While some guidance and recommendations are being drawn for very specific microbiome applications, there is no consolidated regulatory framework applicable to all microbiome products. Any specific requirements should be carefully considered on a case-by-case basis in order to demonstrate the safety and efficacy of these new high potential healthcare solutions. Specific challenges due to the nature of microbiome health products must be addressed for toxicology assessment and clinical translation. Colonization and proliferation processes for live microorganisms need to be controlled. Some solutions are already available for microbiome products development, such as dedicated nonclinical models, and emerging tools such as in silico modeling may potentially prove useful. This chapter aims to draw the regulatory landscape for microbiome-derived products prior to debating various nonclinical tests systems to evaluate their toxicology.

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