Nanomedicines are medicinal products that have a size in the nanoscale range. They have unique properties which allow them to distribute in the body in a way that was previously impossible. This is one of the reasons why nanomedicines have been gaining increasing attention in academia and research.
In spite of the opportunities they bring, nanomedicines are highly complex and their quality attributes are closely linked to their manufacturing process. In order to ensure their safety and efficacy, it is therefore essential that a robust regulatory process exists and that all stakeholders, including health authorities, payers, pharmacists and prescribers are fully aware of their complexities.
No specific, robust nor overarching regulatory framework designed for the nanomedicines exists. The EAASM believes that it is the right time to set the scene for building a consensus so that this regulatory weakness can be addressed and thus provide the highest quality medicines with safety, efficacy and quality attributes. This not only applies to existing medicines but the plethora of new medicines that are in the pipeline.
In collaboration with other European associations, the EAASM has produced a leaflet calling upon DG SANTE, the EMA, Member States’ health authorities and regulatory bodies to address unmet medical needs and enhance quality, safety and efficacy of nanomedicines and nanosimilars by addressing patient safety issues due to significant regulatory challenges across Europe.
A Call to Action to the EU Institutions and Member States Health Authorities