Abstract
This article provides an overview of the European Union (EU) framework for the marketing authorisation of medicinal products, at both European and National level, and aims to demonstrate the current position and experience with nanomedicines. It will be described how the EU promotes the development of new nanomedicines by publishing guidance, providing scientific advice and engaging with multiple regions for the convergence of scientific requirements to support the quality, safety and efficacy of nanomedicines. It will also be highlighted the regulatory challenges deriving from the use of an innovative technology that crosses different platforms and the importance of overcoming challenges for the benefit of public health.
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The views expressed are those of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency.
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Guest Editors: Katherine Tyner, Sau (Larry) Lee and Marc Wolfgang
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Pita, R., Ehmann, F. & Papaluca, M. Nanomedicines in the EU—Regulatory Overview. AAPS J 18, 1576–1582 (2016). https://doi.org/10.1208/s12248-016-9967-1
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DOI: https://doi.org/10.1208/s12248-016-9967-1