Nano-Enabled Medicinal Products: Time for an International Advanced Community?

The application of nanotechnology in healthcare is a driver of biomedical innovation, which could also address unmet medical needs. The number of innovative nanoparticle-enabled medicinal products (NEMPs) being developed has been continually increasing [1], thus challenging both the scientific community and regulators on how to efficiently develop and evaluate these innovative products. The guidelines and reflection papers published by multiple regulatory bodies [2–6] implicitly demand product assessment in their quality, safety and efficacy in order to support their decision-making process, allowing effective translation toward a clinical application and subsequent commercialization. If compared with ‘classical’ small molecule drugs, the assessment for NEMPs demands the investigation of many additional physico-chemical (PC) properties, including particle size distribution and polydispersity, dispersion stability, drug loading and drug release, particle shape, surface charge, surface coating, among many others. To complicate matters, each NEMP is unique, imposing different methodological approaches to characterize its PC properties and to determine the critical quality attributes, which could impact its immunological effects, biodistribution, pharmacokinetics, metabolism and safety profile.