Active ingredient vs excipient debate for nanomedicines

Nanomedicines are complex drugs where components that have typically been regarded as excipients may now be considered part of the active ingredient. The distinction between the active ingredient and excipients for nanomedicines has important consequences for regulatory review and product development. The dissimilarity in the review of the recent ribonucleic acid (RNA)-based lipid nanoparticles highlights the need for further regulatory alignment on this topic.