REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials. The heart of this framework is the development of a product-specific Decision Support System that identifies the most efficient way to deliver the data required by regulation by the best-fitting methods. The decision tree will explicate the product’s specific regulatory challenges and the priorities of both missing data and missing methods to match these challenges. It will thus allow planning a cost and time efficient strategy both for necessary measurements and for the advancement of methods. Our approach is aligned with the industrial R&D practice of stage gating.
The relevance of the framework will be demonstrated for the most pressing regulatory challenges, which are: borderline products, nanosimilars, and products combining several functionalities. In order to do so, the regulatory challenges will be identified with Regulation Authorities from Europe and abroad, and design methods for tiered decision tree, guided by the latest scientific knowledge. The physiological distribution of nanomedicines and biomaterials will be studied/predicted, as well as the development and validation of new analytical or experimental methods and assays requested by the regulators. These latter development will be performed in a quality management system, ensuring the possible standardization of these assays.
REFINE will gather a wide community of stakeholders in regulation, industry, science, technology development, patients, and end-users, into a Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicine.