Summary Report of PQRI Workshop on Nanomaterial in Drug Products: Current Experience and Management of Potential Risks

Abstract

At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

Identification of regulatory needs for nanomedicines

“…All agencies offer early scientific advice procedures for product developer in order to guide them through the approval/authorisation process and they preconize “case‐by‐case” approach to address nano‐specific properties of the product. Furthermore, a number of initiatives were launched within the regulatory agencies to advance the challenges linked to the regulation of nanomedicines (Bartlett et al, ; Yu et al, ). In some countries like the USA, Japan, and in the European Union, some initial guidance documents were released to help product developer in the evaluation of the nanotechnology based products searching for the regulatory approval (Table ).…”

“…In the countries participating in the survey, there is no specific regulatory framework designed for the nanotechnology based products (Bartlett et al, ; Guo et al, ). The so‐called nanomedicines follow the regulation of medicinal products and use common guidelines for their assessment based on ICH guidelines.…”

Nanomedicine for COVID-19: the role of nanotechnology in the treatment and diagnosis of COVID-19

“…There is no clear regulatory framework for nanotechnology-based products in different countries [ 282 ]. Variations reported in the approval process in these countries can arise from regionally different regulatory mechanisms and the classification of pharmaceuticals [ 283 ].…”

The evolving landscape of drug products containing nanomaterials in the United States

“…There is a focus on increasing the awareness of a drug products containing nanomaterials' critical quality attributes (CQAs) and their ultimate impact on drug product quality, safety and efficacy [35][36][37] . One aim of the current analysis was therefore to provide a baseline understanding of how nanomaterials have been characterized in drug products containing nanomaterials.…”