A review of the regulatory framework for nanomedicines in the European Union

摘要: The inclusion of nanotechnology into the development and manufacturing of drugs and medical devices has brought about major gains in efficacy and accuracy. However, with these gains, the novel field of nanomedicine has also introduced many unknowns, the majority of which concern their safety to human health and the environment. Nanomedicine safety and the regulation thereof have been major topics of investigation and discussion by stakeholders in the nanomedicine field. These stakeholders also include the governmental agencies responsible for the regulation of medicines and medical devices. This chapter describes the history of nanomedicine regulation by the institutions of European Union and its member states.