Chapter 10: Developing a Predictable Regulatory Path for Nanomedicines by Accurate and Objective Particle Measurement

The approval of medicines and medical devices is well regulated worldwide, with significant literature, guidelines and legislation to ensure that appropriate procedures are adhered to in order to give confidence in the safety of the product. The development and progression of nanomedicines has the potential to drastically improve the detection, treatment and outlook of many diseases, but it has not come with concomitant development of the regulatory pathways. While some guidelines and regulations have been introduced, there is still a need for clear definitions and pathways to enable transparent, consistent processes to be established for manufacturers to follow. Despite the improved solubility, biodistribution and uptake that is often seen with nanoscale medicines, in many cases the reason behind the effect is unknown. This is sometimes due to the difficulty in characterisation, which poses a number of unique challenges in the nanoscale. Accurate measurement of the size, concentration and charge of the constituent particles can be difficult. This chapter reviews the current regulatory pathways of nanomedicines and the importance of accurate measurement of nanoparticles for this purpose. The current measurement techniques are discussed in relation to the regulatory authorities’ requirements, and potential future directions are considered.