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, quality for public use. Significantly over the past three decades, testing of these products has witnessed increasingly stringent tests due advancing scientific knowledge technology. Specifically, relatively new field studies on human gut microbiome its interactions drugs may accumulate enough evidence in future justify prior approval or during post-marketing surveillance.