On 1 July, the European Nano-Characterisation Laboratory funded by the European Union’s Horizon 2020 research and innovation programme was launched. The laboratory is a cooperative arrangement between Europe and the United States and the first European transnational infrastructure in nano-medicine.
It aims at fostering innovation by sharing knowledge between academia and industry and will ultimately contribute to the competiveness of nano-medicine products and facilitate their regulation in Europe.
The European Nano-Characterisation Laboratory (EU-NCL) will provide a trans-disciplinary testing infrastructure for Europe, fostering the deployment of standard operating procedures, benchmarking materials and quality management of medicinal nano-products. It will also promote inter-sectorial and interdisciplinary communication among key drivers of innovation, especially between developers and regulatory agencies.
The laboratory brings together nine partners from eight countries, including the Nanotechnology Characterization Lab of the National Cancer Institute in the U.S. (U.S. NCL), in order to facilitate the international harmonisation of analytical protocols and to help standardise regulatory requirements for clinical evaluation and marketing of nano-medicine internationally. "The venture holds great promise for using nanotechnologies to overcome cancer and other major diseases around the world", said Scott E. McNeil, director of U.S. NCL.
Within the EU-NCL, six analytical facilities will offer access to their existing analytical services for public and private developers, and will also develop new or improved analytical tests to keep EU-NCL at the cutting edge of nano-medicine characterisation.
The JRC will contribute to the EU-NCL activities through the development of new methods for nanomaterial characterisation and the application of these methods for nano-medicine analysis prior to pre-clinical tests.
The JRC has a long-standing expertise in pre-normative research and the harmonisation of regulatory methods for the testing of nanomaterials. Under the EU-NCL programme, this expertise will be used for developing appropriate methods for assessing the quality and safety of nano-medicines. The JRC will also provide technical and scientific expertise to the working groups and technical committees of European and international standardisation bodies such as OECD and ISO, thus ensuring that the relevant standardisation actions take the novel and rapidly developing field of nano-medicine into consideration.
Finally, as part of its core mission, the JRC will provide informed advice to policy makers regarding the field of nano-medicine and will contribute to the development and provision of guidance on regulation and policy implementation to stakeholders. In all of the above activities, the JRC will interact and engage with stakeholders and actively contribute to the dissemination of information about the EU-NCL activities and results.
The EU-NCL project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 654190.