REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials.
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.
REFINE long-term vision is that the REFINE framework will support:
Regulatory science to quickly analyse whether a new NBM raises new challenges to testing.
Producers, CRO/CDMOs to design safer products, and more efficient testing & manufacturing.
Researchers to meet urgent needs of regulators and define Adverse Outcome Pathways.
REFINE will support safer, more cost- and time-efficient testing, in a framework that will remain sustainable beyond the project.
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.
To set up/ build a Regulatory Science framework to close the gap presently on the existing development of nanomedicine products. We aim to set in motion a sustained forum that liaises regulators, scientist, and developers in the task to develop:
A clear overview of current and anticipated regulatory concerns, including harmonisation,
A gap analysis where regulatory concerns and scientific evidence don’t seem to match up,
A heuristic to transfer new scientific evidence into regulatory strategies, and to translate regulatory concerns into hot spots in the standard testing cascades