Europe has been supporting the development of nanomedicine and the emergence of companies in the medical field for 15 years. Given the rapid evolution of available technologies in this area, legislation had to evolve too.
To overcome regulatory stumbling blocks regarding market access for these medicinal products and make up ground on the USA, the European Union has implemented Refine, a project designed to bring information to regulators and developers of nanomedical healthcare solutions to assist in their decision-making. Refine will provide the most advanced analytical developments to help them understand what happens to nanodrugs in the human body and therefore better determine their toxicity and efficacy.
The objective is to develop tests that will improve the preclinical characterisation of nanodrugs. The ultimate aim is to ensure that the safety of these nanodrugs is thoroughly assessed before a licence is issued for clinical trials or medical applications.
"We are preparing a decision support system specific to each product, to identify the most efficient means of providing the data required by legislation through the best analytical methods. By the end of the Refine project timeline, a decision tree will indicate the regulatory framework that will specifically apply to a given product, highlight which data is missing and point out the optimum methods to comply with this legislation. Companies will then be able to map out a cost- and time-efficient market access strategy. Obviously, this approach is aligned with industrial R&D practices ", explains Simon Baconnier, CEA-Leti Researcher and Refine Project Coordinator for the CEA
Refine brings together a vast community of stakeholders in the fields of law, industry, science and technological development, in addition to patients and end users, within a consortium set up to progress regulatory science in biomaterials and nanomedicine.