Project Summary
Over the past three decades, the applications of nanotechnology in pharmaceutical drug products have resulted in many benefits to the patient and the society, for e.g., the doxorubicin liposome for treatment of ovarian cancer and Kaposi sarcoma, and more recently the lipid nanoparticles as carriers for messenger RNA (mRNA) for some COVID-19 vaccines. However, there remains a critical lack of both documentary and reference material standards. In 2016, FDA organized the “Global Summit on Regulatory Science (GSRS16) on Nanotechnology Standards and Applications” in collaboration with other regulatory agencies and standards development organizations across the globe to identify a list of standards needs in nanotechnology through stakeholder engagement. Since then, a number of standards have been developed through ASTM International E56 Committee on Nanotechnology (https://www.astm.org/get-involved/technical-committees/committee-e56) and ISO TC229 (https://www.iso.org/committee/381983/x/catalogue/p/0/u/1/w/0/d/0). FDA recognized 20 consensus standards to date under Specialty Task Group Area: Nanotechnology. (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) This list gets updated periodically when new standards are considered for recognition.
The primary aim of this survey is to probe and update the current and upcoming needs and prioritize the development of standard analytical methods for physicochemical characterization, quality and equivalence assessment of products that contain nanomaterials, including for drug delivery, gene delivery and combination products. The benefit of adopting and use of the international standards may include reduction in developmental cost, increase in predictability during premarket review, among others. However, active communication and dialog among key stakeholders (e.g., industry, academia, regulatory agency) on the current thinking and the preparedness of the pre-market product development and assessment of complex nanotechnology-based products is crucial. Input on this survey will help identify training, research and standards needs that will facilitate the development of new and generic complex products.
The survey is currently closed and the summary of the survey results will be shared on our website once it is available.