Regulatory Science Framework for Nano(bio)material-based Medical Products and DevicesAbout
What REFINE is proposing and aiming
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 approach is aligned with the industrial R&D innovation and developmental practice.
We will demonstrate the relevance of the framework for the most pressing regulatory challenges. These 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.
Regulatory Scientific Framework – REFINE Approach
Presently, nanomedicines follow the regulation of medicinal products and use common guidelines for their assessment based on ICH guidelines. However, the differences in the approval process can originate from regionally different legislative frameworks and classification of pharmaceuticals.
All national regulatory agencies provide scientific advice and support for approval/authorisation in a “case-by-case” approach to address the “nano-specific” properties of the nanomedicines. This has been presented in several recent publications, books, and perspective on the aspect of nanomedicine product regulation.
(Pharmaceutical Nanotechnology, Innovation and Production, 2017 (Book); Handbook of Clinical Nanomedicine, 2016 (book); Bremer-Hoffmann et al., JOIN 2018 (article); Narang et al., JPS 2013 (commentary), and others.