Table 3.

Nanomedicine guidelines published by FDA, EMA, MHLW, and NMPA.

Regulatory Agency	Nanomedicine Guidelines
FDA	Guidance for industry: Considering whether an FDA-regulated product involves the application of nanotechnology; Drug products, including biological products, that contain nanomaterials guidance for industry (draft); Guidance for industry: liposome drug products chemistry, manufacturing, and controls; human pharmacokinetics and bioavailability; and labeling documentation.
EMA	Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product; Surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products; Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product; Development of block-copolymer-micelle medicinal products—Joint EMA and MHLW; Non-clinical studies for generic nanoparticle iron medicinal product applications.
MHLW	Development of block-copolymer-micelle medicinal products—Joint EMA and MHLW; Guideline for the Development of Liposome Drug Products; Reflection paper on nucleic acids (siRNA)-loaded nanotechnology-based drug products.
NMPA	Guideline for the quality control of nanomedicines (draft); Guideline for the non-clinical pharmacokinetics of nanomedicines (draft); Guideline for the non-clinical safety evaluation of nanomedicines (draft).