Nanomedicines and nanocarriers in clinical trials: surfing through regulatory requirements and physico-chemical critical quality attributes.

Abstract

Elucidation of physical-chemical characteristics of investigational medicinal products should be established with suitable methodology. Characterization of nanomedicines and nanocarriers in clinical trials may require the definition of additional specific properties depending on the nature of the nanostructures or nanomaterials composing the investigational medicinal product. The availability of regulatory requirements and guidelines is investigated focusing on critical quality attributes for nanomedicines and nanocarriers, mapping them in a clinical trial setting. Current regulatory challenges and issues are highlighted. The increasing complexity of nanostructures, the innovative connotation of applied nanotechnology, and the lack in capillarity or misalignment of relevant guidelines and terminology may lead to a potential not standardized approach in the characterization of nanomedicines and nanocarriers in clinical trials and delays in the approval process. Further efforts and a proactive approach from a regulatory standpoint would be desirable to surf the wave of innovation that impact nanomedicines and nanocarriers in clinical trials, in order to support clinical drug development capitalizing on technological advances and still ensuring a strong regulatory framework.