Nanotechnology (NTc), specifically NTc-based therapeutic products and substances, has opened up a world of possibilities for innovative solutions to most of the current challenges societies face presently. On the other hand, NTc is a product development field that moves quicker than the regulatory landscape and frameworks. It is due to the complexity of specific nanomaterials (NMs) and nanomedicines (NMc), the unavailability of an interna-tionally standardized regulatory framework, and worldwide regulatory landscape differences. In the last two decades, scientific institutions and regulatory agencies have put in a lot of effort to meet these issues. However, there has been substantial progress in significant analytical methodologies for labelling applications and the creation of appropriate test criteria for NMs and their safety analysis. More worldwide collaboration and cooperation in the regulatory area is still required. The growing presence of nano-based products in almost every sphere of science, especially in pharmaceuticals has again proved the vital significance of NTc in today's world. However, it has also led to concerns regarding their associated quality, safety, efficacy, and toxicity issues among the public and scientific communities. Here comes the role of the regulators to ensure the maintenance of reg-ulatory concerns of NMs and NMc, hence maintaining the confidence and trust of the public as well. However, due to the complicated nature of the NMs, they pose particular challenges for the regulators to form necessary legislations, guidelines, and rules. This review has focused to discuss regulatory challenges, safety assessments, and regulatory guidelines comprehensively. Moreover, the clinical significance, NMc approved or under clinical development, and the current global regulatory landscape of NMs and NMc have been presented.
