THE HUMAN GUT MICROBIOME: CONSIDERATIONS TOWARD REGULATORY TESTING FOR DRUGS AND VACCINES

Health regulatory authorities worldwide are tasked with approving drugs, medical devices, and vaccines to ensure their safety, efficacy, and quality for public use. Significantly over the past three decades, testing of these products has witnessed increasingly stringent tests due to advancing scientific knowledge and technology. Specifically, the relatively new field of studies on the human gut microbiome and its interactions with drugs and vaccines may accumulate enough evidence in the future to justify its testing prior to regulatory approval or during post-marketing surveillance.