Nanotechnology is a compelling and growing scientific field that provides numerous opportunities to develop innovative medicines to address unmet medical needs and create alternatives for many therapeutic areas – from cancer to inflammation, neurological and cardiovascular disorders. Nanoparticles are now present in the new RNA vaccines.
To fully harness their potential and protect patient safety, a fit for purpose regulatory framework for this class of products is needed at EU and International level. Nanomedicines and nanosimilars should be reviewed through a centralised procedure to limit different approaches by Member States regulatory authorities and a separate regulatory framework for nanosimilar “follow-on” products would be beneficial – as it has been for the development of biosimilars over the past years.
The independent non-profit patient safety organisation – the European Alliance for Access to Safe Medicines - EAASM is therefore raising awareness amongst all interested parties of the need for scientific consensus on definitions for nanomedicines across Europe. It is doing this through an advocacy programme comprising a scientific report, summary briefing document and EU Parliament round table discussions as well as a comprehensive outreach campaign to MEPs and stakeholders. This campaign aims to inform the development of the good work that the EMA and DG SANTE are currently undertaking to meet this new regulatory challenge and to accelerate the development of a specific regulatory framework for nanomedicines and nanosimilars.
This initiative is needed as of nanomedicines are complex and because their therapeutic profiles are determined by the manufacturing process which makes them very hard to replicate. In addition, the approval of original medicines and “follow-on” copy products is currently not homogeneous leading to different regulatory agencies taking different approaches.
The EAASM has therefore identified a need for clinical trial protocols to be standardised and for new guidelines to be developed on identifying the clinical quality attributes of these products.
And most Importantly from a patient safety perspective there is clear evidence that nanosimilar or “follow-on” copy products have not always delivered the same efficacy and safety as their originators due to flaws in their regulatory approval process.
The EAASM is in the process of forming a strong and growing alliance which currently comprises IAPO, the International Alliance of Patients’ Organisations, ELP, the European Liver Patients Association and EPD, the European Parkinson’s Disease Association and professional organisations such as ESNO, the European Specialist Nurses Organisation and ERA-EDTA which is the European Renal Association – European Dialysis and Transplant Association.
Please consider joining this alliance and/or signing the petition which can be found here. The EAASM would welcome your support.
For quick reference to the scientific report and the summary leaflet, please click here.
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