Nanomedicines are medicinal products of at least one dimension in the nanoscale ranges – from 1nm to 100nm. They enhance the way in which medicines target and reach areas of disease within the body, opening new therapeutic options. They offer potential solutions for current treatment challenges, such as cancer, cardiovascular and neurodegenerative diseases, as well as other illnesses. In recent years, a consequent number of developments occurred in the area of nanomedicines.

At present the EU lacks a fit-for-purpose regulatory framework specific to these products and their off-patent follow-on copy products, nanosimilars. This leads to unnecessary risks for patient safety.

This 24 February 2022, the EAASM has published a new article “Nanomedicines and Nanosimilars — The EU urgently needs a Robust Centralised Regulatory Framework to Enhance Patient Safety” in the prestigious medical journal Frontiers. It is an urgent requirement that the EU takes action to enhance patient safety in this area and prevent patient harm. At the moment, nanomedicines in the EU can be assessed under four different types of procedure: the national procedure, the decentralised procedure, mutual recognition, and the centralised procedure. This has led to strong regional differences in the regulation of nanomedicines and allows for the marketing of different brand names, which in turn makes pharmacovigilance linkage difficult and thus compromises patient safety.

The EU Nanomedicines Regulatory Coalition, as part of the EAASM, calls on the EU to establish a framework whereby all nanomedicines and nanosimilars are assessed through an EMA centralised regulatory procedure.