A fructan-type plant polysaccharide, inulin (IN), is abundantly distributed in the natural world. The main plant sources of IN are Jerusalem artichokes, chicory, and dahlia. Its unique and flexible structure, stabilizing/protecting qualities, and organ-targeting ability distinguish it from other biodegradable polysaccharides, making it a potential carrier for drug delivery. Inulin has three hydroxyl groups on each fructose unit which serve as platform for chemical modification. This promotes targeted, prolonged, and regulated release of medications and biomolecules while also enhancing cellular absorption and bioavailability. It provides a thorough analysis of the preliminary studies required for regulatory approval of pharmaceuticals based on inulin. It explores the complexities of preclinical research, encompassing investigations into toxicity, pharmacokinetics, pharmacodynamics, and formulation development. Determining whether inulin is a dietary fiber or a medication, ensuring safety and effectiveness through clinical trials, and adhering to international standards for purity and quality are important factors to be taken into consideration. Regulatory frameworks differ across regions, requiring thorough compliance strategies for market access. Regulating agencies have strict standards for the quality and purity of pharmaceuticals, especially inulin-containing formulations. Good manufacturing practice (GMP) compliance is essential for maintaining the reliability and consistency of manufacturing processes, which reduces the possibility of contamination or variances in product quality. It addresses the complicated area of intellectual property protection, highlighting how crucial it is to protect innovation in order to increase patient access to these valuable medications. This chapter examines the complex structure of regulations governing these products’ manufacture, labeling, and distribution.