International harmonization of regulation of nanomedicine

Gary Marchant, Douglas Sylvester, Kenneth Abbott, Tara Lynn Danforth

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nano-technologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether there are mechanisms of international harmonization or cooperation that can facilitate the development of more effective and efficient regulatory regimes for nanomedicine? Part I of this paper briefly summarizes the promise of nanomedicine as well as potential concerns about the risks of nanomedical applications that will require regulatory oversight. In Part II, we analyze the various factors weighing for and against attempts to harmonize regulatory requirements at the international level. Finally, in Part III we identify some specific existing or feasible mechanisms that may be useful for fostering international harmonization in the regulation of nanomedicine.

Original languageEnglish (US)
Article number6
JournalStudies in Ethics, Law, and Technology
Volume3
Issue number3
DOIs
StatePublished - 2009

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Medical nanotechnology
nanotechnology
harmonization
regulation
Nanotechnology
Disease
Weighing

Keywords

  • Harmonization
  • International
  • Medicine
  • Nanotechnology
  • Regulation

ASJC Scopus subject areas

  • Computer Science Applications
  • Law
  • Sociology and Political Science

Cite this

International harmonization of regulation of nanomedicine. / Marchant, Gary; Sylvester, Douglas; Abbott, Kenneth; Danforth, Tara Lynn.

In: Studies in Ethics, Law, and Technology, Vol. 3, No. 3, 6, 2009.

Research output: Contribution to journalArticle

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