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The AAPS Journal

, Volume 18, Issue 6, pp 1576–1582 | Cite as

Nanomedicines in the EU—Regulatory Overview

  • Ruben PitaEmail author
  • Falk Ehmann
  • Marisa Papaluca
Regulatory Note Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future
First Online:
Part of the following topical collections:
  1. Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future

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.

KEY WORDS

EMA EU innovation nanomedicine regulatory science 
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Notes

Compliance with Ethical Standards

Disclaimer

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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Copyright information

© American Association of Pharmaceutical Scientists 2016

Authors and Affiliations

  1. 1.European Medicines AgencyLondonUK

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