Launched in December 2017, H2020 project REFINE aims to develop a regulatory science framework for nanotechnology-enabled health products. Recently released REFINE’s White Paper summarises main regulatory challenges in the field and provides information on relevant legislative/regulatory frameworks and involved organisations.
The REFINE White Paper and related scientific publication “Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products” call for a discussion on identified challenges among the involved communities, including regulators, industry and academia. In order to better understand the needs and perspectives of different communities a short questionnaire is available HERE. The feedback should help to develop an improved version of the White Paper
About the REFINE Framework
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.