In an article published this week by Parliament Magazine, Member of the European Parliament Petar Vitanov called for a centralized regulatory approach to nanomedicine.
The article supports the recommendations formulated in September 2020 in a report by the European Alliance for Access to Safe Medicines and including: the development of a scientific consensus on a nanomedicine definition; the adoption of a centralized procedure by the European Medicines Agency (EMA) for all nanomedicines; and the clarification of the regulatory criteria for the approval of follow-on/nanosimilar medicines. The recommendations as well as the full report can be found here.
As the NIA had already had the opportunity to discuss (see our Nano-Blog), the vast complexity of materials and applications in nanomedicine means that the development of a regulatory definition would be no easy task. It should also be noted that the EU already has a stringent regulatory framework in place to ensure medicine safety, which also covers nano applications.
A few of these interesting nanomedicine applications were covered in the NIA webinar Diagnostics and therapeutics advancing through nanotechnology, whose materials are available here; and in the joint event with INL, Nanomedicine - What is it and what can it be used for? (information at this link).
