Identification of regulatory needs for nanomedicines

Europe received fewer submissions of nanomedicines for market authorisation in comparison to other regions in the world in the last five years.

This is one of the major outcomes of a recent survey performed with international regulatory bodies done by JRC scientists in collaboration with the Norwegian SINTEF Institute for Materials and Chemistry.

Ten regulatory bodies of the International Pharmaceutical Regulators Forum (IPRF) Nanomedicines Working Group participated in the survey providing a general overview on regulatory needs of nanomedicines and indicated some trends on future requirements.

Besides strong regional differences in the number of applications for the authorisation of nanomedicines, the survey summarised the regulatory relevance of information requirements related to the physicochemical characterisation of the nanomaterial. It also highlighted potential needs of additional (eco)toxicological testing.

Finally, the survey confirmed the interest of regulatory agencies in a characterisation testing facility that can support nanomedicine developers and at the same time assess the performance of existing and new characterisation methods for their application to the field of nanomedicine.

An increase of applications for market authorisation can also be expected in Europe as other regions such Canada, Taiwan and USA are already facing challenges in the regulation of nanotechnology enabled health products. The anticipation of additional information requirements related to the quality, safety and efficacy of these innovative products as well as standardised methods is needed to allow a smooth translation towards clinical applications.

Read more in: Susanne Bremer-Hoffmann, Blanka Halamoda-Kenzaoui and Sven Even F. Borgos, Identification of regulatory needs for nanomedicines, EUR 28224 EN, doi 10.2788/585950 (with the support of H2020 EU-NCL project)

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Identification of regulatory needs for nanomedicines