The JRC has published a detailed report into the slow development of regulatory framework around nanomedicines, highlighting a common challenge in all emerging technologies, that science and applications accelerate far more quickly than the regulatory ecosystem in which they operate.
The unique, complex and innovative nature of medical needs and novel products is a challenge regardless of scale, particularly when the mode of action often cannot be fully elucidated for a new medicine. The report highlights the speed of innovation and lack of datasets and aims to guide research projects in outputs that support regulatory framework development.
Dr Claire Skentelbery, NIA DG commented "from the NIA perspective, comprehensive public datasets are unlikely to ever be viable for such novel and unique materials, particularly for increasingly personalised medicine, however the high value nature of medical products does create a greater market drive for advanced characterisation. Nano is a strong enabler of new medicines, particularly for clinically unmet needs and regulations need to reflect ambitious intentions and speed into clinic."
The full white paper can be downloaded HERE.
