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Nanomedicine: Principles, Properties, and Regulatory Issues.

Sara Soares1, João Sousa1,2, Alberto Pais3

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Nanotechnology has revolutionized drug development, introducing nanomedicines to the pharmaceutical market. This review explores their concepts, methodologies, challenges, and regulatory landscape, particularly in the EU.

Keywords:
nanomaterialsnanomedicinenanotechnologynanotoxicologypharmaceutical development

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Area of Science:

  • Nanotechnology's impact on pharmaceutical sciences.
  • Evolution of nanomedicines and nanosystems.

Background:

  • Nanotechnology offers unique properties for drug delivery.
  • Significant advancements in new drug substances and products.

Purpose of the Study:

  • Review the introduction of nanomedicines into the pharmaceutical market.
  • Discuss controversies in basic concepts and methodologies for nanosystems.
  • Critically analyze challenges and regulatory issues in nanomedicine development.

Main Methods:

  • Review of scientific literature on nanomedicines.
  • Analysis of methodologies for nanosystem characterization.
  • Discussion of regulatory frameworks, focusing on the European Union.

Main Results:

  • Nanotechnology has significantly advanced drug development.
  • Controversies exist regarding nanomedicine concepts and characterization.
  • Regulatory hurdles are a key challenge for market introduction.

Conclusions:

  • Nanomedicines represent a significant evolution in pharmaceuticals.
  • Further clarification of concepts and standardization of methods are needed.
  • Regulatory harmonization is crucial for broader EU adoption and future development.