Nanotechnological medical devices and nanopharmaceuticals: the European regulatory framework and research needs
- PMID: 18283854
Nanotechnological medical devices and nanopharmaceuticals: the European regulatory framework and research needs
Abstract
The European regulatory framework is examined in relation to nanotechnology based medical devices and medicinal products. Medical applications of nanotechnology will have to comply with the requirement for a high level of public health, safety, consumer, and environmental protection. An evaluation of the possible health or environmental risks of nanoparticles must therefore be carried out and it is important to ensure that particle size and chemistry are taken into account when investigating possible adverse effects. Further research is needed on the toxicological and ecotoxicological properties of nanoparticles, their uptake in the body, accumulation in tissues and organs, transport characteristics, exposure and dose-response data, and their distribution and persistence in the environment. The existing regulations appear adequate to manage the risks of nanotechnology at its current stage of development but continuous review of the regulatory regime will be needed to determine whether it is sufficient to protect human health and the environment. Modification of the legislation may prove necessary as new scientific evidence emerges regarding the effects of nanoparticles on living organisms and in the ecosystems.
Similar articles
-
Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.Food Chem Toxicol. 2008 Mar;46 Suppl 1:S2-70. doi: 10.1016/j.fct.2008.02.008. Epub 2008 Feb 13. Food Chem Toxicol. 2008. PMID: 18328408 Review.
-
Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology.J Intern Med. 2010 Jan;267(1):89-105. doi: 10.1111/j.1365-2796.2009.02187.x. J Intern Med. 2010. PMID: 20059646
-
Do nanoparticles present ecotoxicological risks for the health of the aquatic environment?Environ Int. 2006 Dec;32(8):967-76. doi: 10.1016/j.envint.2006.06.014. Epub 2006 Jul 21. Environ Int. 2006. PMID: 16859745 Review.
-
Legal aspects of E-HEALTH.Stud Health Technol Inform. 2008;141:47-56. Stud Health Technol Inform. 2008. PMID: 18953124
-
[Procedures and methods of benefit assessments for medicines in Germany].Dtsch Med Wochenschr. 2008 Dec;133 Suppl 7:S225-46. doi: 10.1055/s-0028-1100954. Epub 2008 Nov 25. Dtsch Med Wochenschr. 2008. PMID: 19034813 German.
Cited by
-
Nanoparticle delivery systems, general approaches, and their implementation in multiple myeloma.Eur J Haematol. 2017 Jun;98(6):529-541. doi: 10.1111/ejh.12870. Epub 2017 Mar 28. Eur J Haematol. 2017. PMID: 28208215 Free PMC article. Review.
-
Of risks and regulations: how leading U.S. nanoscientists form policy stances about nanotechnology.J Nanopart Res. 2009 Oct;11(7):1573-1585. doi: 10.1007/s11051-009-9671-5. Epub 2009 Jun 17. J Nanopart Res. 2009. PMID: 21170136 Free PMC article.
-
Nanomedicine--challenge and perspectives.Angew Chem Int Ed Engl. 2009;48(5):872-97. doi: 10.1002/anie.200802585. Angew Chem Int Ed Engl. 2009. PMID: 19142939 Free PMC article. Review.
MeSH terms
Substances
LinkOut - more resources
Medical