The JRC organised a dedicated workshop to bridge scientific communities involved in progressing the regulatory science of nanomedicines. There was a general agreement by the participants that existing standards and guidance documents might not be always sufficient for the regulation of nanomedicines due to their particularities.
There is increasing evidence that the application of nanotechnology in the medical field can address in the future unmet medical needs, such cancer, dementia, cardiovascular diseases. This results in a growing trend of the global nanomedicine market. In order to leverage the numerous opportunities for the patients and the economic growth in this sector, an early-on – ideally during product development - common understanding of regulatory requirements between product developer and regulatory bodies of the various regions is essential.
To discuss these issues, the JRC hosted a dedicated workshop on 27-28 September 2017 with twenty scientists representing various pan European regulatory organisations and partners in Horizon 2020 projects.
The participants discussed challenges and upcoming needs in quality and safety assessments of nanomedicines. A focus of the discussions was on the potential interaction of nanomedicines with the blood and immune system. Regulatory uncertainties that might hinder the translational process were identified and can now be addressed in ongoing Horizon 2020 projects such as the European Nanomedicine Characterisation Laboratory.
The discussions and recommendations will be published in a peer reviewed journal.
- 11. detsember 2017