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UK – Decision tree for navigating nanotechnology-based products for medical application

MHRA has received an increase in interest and scientific advice queries on nanomedicines in recent years, particularly on lipid nanoparticles. There appears to be a perception that there is no clear regulatory pathway available for these products and researchers are unclear how to develop their products in accordance with the various guidelines currently in place. 

The decision tree 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).

More information on the MHRA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (26 mars 2025). UK – Decision tree for navigating nanotechnology-based products for medical application. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/13knl


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