# Decision tree for navigating nanotechnology-based products for medical application

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/4b18ad28-181c-4283-bb80-9da835ed474b
Type: Standard
Published: February 5, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance to address the increasing interest and perceived lack of regulatory clarity regarding nanomedicines, specifically lipid nanoparticles and liposomes. This document introduces a decision tree designed to help researchers navigate the development process in accordance with existing frameworks from the International Council for Harmonisation (ICH) and various European regulatory agencies. The guidance identifies specific pathways for both new active substances and 'nanosimilar' products, helping developers understand how to apply technical requirements to nano-based drug delivery systems. While the decision tree provides a useful starting point, the MHRA clarifies that it does not cover medical devices and should not serve as a substitute for direct consultation. Therefore, the MHRA recommends that companies and researchers actively engage with the MHRA Innovation Office or schedule formal scientific advice meetings to discuss product-specific challenges and ensure full regulatory compliance during the development of these complex medicinal products.

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## Content

We have 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 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). It should be noted, however, that the nanomedicine decision tree is not considered as a substitute for a regulatory or scientific advice meeting with the MHRA when specific issues may also need to be considered for your medicinal product or medical devices. Consideration for medical devices is also outside the scope of this decision tree. Researchers and companies are encouraged to submit your queries relating to nano-medicines or devices for regulatory or scientific advice, when appropriate. For more information, see our guidance on seeking scientific advice from the MHRA and contacting the MHRA Innovation Office .

## Attachments

- [Nanomedicine decision tree](https://assets.publishing.service.gov.uk/media/67a371fc567402152f553c82/Nanomedicine_decision_tree.pdf)