REFINE – Dec 2017 – Feb 2022

Project Details: Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices)

Specific challenge: REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials. 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.

Scope: The heart of our 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.

Expected Impact: We will demonstrate the relevance of the framework for the most pressing regulatory challenges, which are: borderline products, nanosimilars, and products combining several functionalities. In order to do so, we will identify the regulatory challenges with Regulation Authorities from Europe and abroad, and design methods for tiered decision tree, guided by the latest scientific knowledge. We will study/predict physiological distribution of nanomedicines and biomaterials, as well as develop and validate 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 standardisation of our assays.

Funded under

  • INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Overall budget € 7,967,941.00

TCD PI: Dr Adriele Prina-Mello, TTMI, School of Medicine

TCD budget: € 633,990.00

Weblink at European Commission portal:

Results and outcomes available at: