The decision tree above is to help support researchers and developers to understand how different guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and European regulatory agencies can be applied to support the development of nanomedicines, although they are not meant to be exhaustive. The classification, new active substances or ‘nanosimilar’ pathways are highlighted in the flow diagram as well. This may help support development of medicinal products involving ‘nano’ drug delivery systems liposomes and lipid nanoparticles (LNPs)…
