Advertisement

Regulatory Normative of Nanomaterials for Their Use in Biomedicine

  • Caitlin Lazurko
  • Manuel Ahumada
  • Emilio I. Alarcon
  • Erik JacquesEmail author
Chapter

Abstract

With nanomedicines increasing in market value and disruptive potential, a rapidly moving field such as this will require engaging in the difficult task of responsible management and the development of appropriate guidelines, which falls into the jurisdiction of governmental agencies. While each is influenced by the countries politics and demands of the people, there are shared goals of improving market success, risk assessment, and safety optimization. In this chapter, we describe the regulatory landscape with regards to nanomedicines in various countries. We first start with the world’s nanotechnological leaders in North America, the European Union, and Asian and then discuss the notable strides taken by emerging countries where nanomedicines have caught the public eye.

Notes

Acknowledgements

Dr. Alarcon thanks the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), Ministry of Economic Development, Job Creation and Trade for an Early Researcher Award, and the New Frontiers in Research Fund—Exploration for a research Grant. Ms. Lazurko thanks the Queen Elizabeth II Graduate Scholarships in Science and Technology for financial support. Dr. Ahumada thanks the CONICYT—FONDECYT (Iniciación en la Investigación) grant #11180616, and to FDP-Universidad Mayor grant #I-2019077.

Disclosures

All authors have read and approved the final version.

References

  1. 1.
    Larsson S, Jansson M, Boholm Å. Expert stakeholders’ perception of nanotechnology: risk, benefit, knowledge, and regulation. J Nanopart Res. 2019;21(3):57.CrossRefGoogle Scholar
  2. 2.
    Corley EA, Scheufele DA, Hu Q. Of risks and regulations: how leading U.S. nanoscientists form policy stances about nanotechnology. J Nanopart Res. 2009;11(7):1573–85.CrossRefGoogle Scholar
  3. 3.
    Bowman DM, Hodge GA. Nanotechnology: mapping the wild regulatory frontier. Futures. 2006;38(9):1060–73.CrossRefGoogle Scholar
  4. 4.
    FDA’s approach to regulation of nanotechnology products. https://www.fda.gov/science-research/nanotechnology-programs-fda/fdas-approach-regulation-nanotechnology-products (2018). Accessed 23 May 2019.
  5. 5.
  6. 6.
    Nanotechnology task force report 2007. https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-task-force-report-2007 (2019). Accessed 24 May 2019.
  7. 7.
    2013 Nanotechnology regulatory science research plan. https://www.fda.gov/science-research/nanotechnology-programs-fda/2013-nanotechnology-regulatory-science-research-plan (2013). Accessed 23 May 2019.
  8. 8.
    Research on nanomaterials. https://www.epa.gov/chemical-research/research-nanomaterials (2019). Accessed 24 May 2019.
  9. 9.
    Control of nanoscale materials under the toxic substances control act. https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/control-nanoscale-materials-under (2019). Accessed 24 May 2019.
  10. 10.
    Policy statement on health Canada’s working definition for nanomaterial. https://www.canada.ca/en/health-canada/services/science-research/reports-publications/nanomaterial/policy-statement-health-canada-working-definition.html (2019). Accessed 23 May 2019.
  11. 11.
    Nanomaterials and their applications in textiles—standards. https://www.ic.gc.ca/eic/site/textiles-textiles.nsf/eng/h_tx03226.html (2019). Accessed 23 May 2019.
  12. 12.
    Amenta V, Aschberger K, Arena M, Bouwmeester H, Botelho Moniz F, Brandhoff P, Gottardo S, Marvin HJP, Mech A, Quiros Pesudo L, et al. Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries. Regul Toxicol Pharm. 2015;73(1):463–76.CrossRefGoogle Scholar
  13. 13.
    Joint action plan for the Canada-United States regulatory cooperation council. https://www.canada.ca/en/treasury-board-secretariat/corporate/transparency/acts-regulations/canada-us-regulatory-cooperation-council/joint-action-plan.html#s4.5.2 (2019). Accessed 23 May 2019.
  14. 14.
    Vencken SF, Greene CM. A review of the regulatory framework for nanomedicines in the European Union. In: Grumezescu AM, editor. Elsevier Inc.; 2018. p. 641–79.Google Scholar
  15. 15.
    Pita R, Ehmann F, Papaluca M. Nanomedicines in the EU—regulatory overview. AAPS J. 2016;18(6):1576–82.CrossRefGoogle Scholar
  16. 16.
    D’Silva J, Van Calster G. Taking temperature—a review of European union regulation in nanomedicine. Eur J Health Law. 2009;16(3):249–69.CrossRefGoogle Scholar
  17. 17.
    Ehmann F, Sakai-Kato K, Duncan R, Pérez de la Ossa DH, Pita R, Vidal J-M, Kohli A, Tothfalusi L, Sanh A, Tinto S, et al. Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines. Nanomedicine 2013;8(5):849–56.CrossRefGoogle Scholar
  18. 18.
    Soares S, Sousa J, Pais A, Vitorino C. Nanomedicine: principles, properties, and regulatory issues. Front Chem. 2018;6:1–15.CrossRefGoogle Scholar
  19. 19.
    Satterstrom FK, Arcuri ASA, Davis TA, Gulledge W, Foss Hansen S, Shafy Haraza MA, Kapustka L, Karkan D, Linkov I, Melkonyan M, et al. Considerations for implementation of manufactured nanomaterial policy and governance. In: Linkov I, Steevens J, editors. Dordrecht: Springer; 2009. p. 329–51.Google Scholar
  20. 20.
    Trisolino A. Nanomedicine: building a bridge between science and law. NanoEthics. 2014;8(2):141–63.CrossRefGoogle Scholar
  21. 21.
    Teunenbroek TV, Baker J, Dijkzeul A. Towards a more effective and efficient governance and regulation of nanomaterials. Part Fibre Toxicol. 2017;14(54):1–5.Google Scholar
  22. 22.
    Canu IG, Schulte PA, Riediker M, Fatkhutdinova L, Bergamaschi E. Methodological, political and legal issues in the assessment of the effects of nanotechnology on human health. J Epidemiol Commun Health. 2018;72(2):148–53.CrossRefGoogle Scholar
  23. 23.
    Kreyling WG, Semmler-Behnke M, Chaudhry Q. A complementary definition of nanomaterial. Nano Today. 2010;5(3):165–8.CrossRefGoogle Scholar
  24. 24.
    Taniguchi N. On the basic concept of nano-technology. In: Proceedings of international conference on production engineering. London; 1974.Google Scholar
  25. 25.
    Iijima S. Helical microtubules of graphitic carbon. Nature. 1991;354(6348):56–8.CrossRefGoogle Scholar
  26. 26.
    StatNano. Japan indicators. https://statnano.com/country/japan (2019). Accessed 25 May 2019.
  27. 27.
    Director General of Labour Standards Bureau M. Notification on precautionary measures for prevention of exposure etc. to and other effects of nanomaterials. In: Ministry of Health Law, editor. 2009.Google Scholar
  28. 28.
    Strategy CfRaD. Nanotechnology and materials R&D in Japan (2018): an overview and analysis. In: Unit NM, editor. 2018. p. 86.Google Scholar
  29. 29.
    Tolochko N. History of nanotechnology. In: Valeri NCB, Sae-Chul K, editors. Nanoscience and nanotechnologies. Encyclopedia of Life Support Systems (EOLSS). Oxford: Eolss Publishers; 2009.Google Scholar
  30. 30.
    Ministry of Education C, Sports, Science and Technology. Science and technology basic plan. http://www.mext.go.jp/en/policy/science_technology/lawandplan/title01/detail01/1375311.htm (2019). Accessed 28 May 2019.
  31. 31.
    Office C. The 5th science and technology basic plan. In: Office C, editor. 2016.Google Scholar
  32. 32.
    Žagar A. Nanotech cluster and industry landscape in Japan. 2014.Google Scholar
  33. 33.
    Japan So. 2015 Population census. In e-Stat https://www.e-stat.go.jp/en/stat-search/files?page=1&toukei=00200521&tstat=000001080615&second=1 (2019). Accessed 28 May 2019.
  34. 34.
    Worldometers. Japan population. https://www.worldometers.info/world-population/japan-population/ (2019). Accessed 29 May 2019.
  35. 35.
    Bank TW. Japan. In data https://data.worldbank.org/country/japan (2019). Accessed 29 May 2019.
  36. 36.
    Matteucci F, Giannantonio R, Calabi F, Agostiano A, Gigli G, Rossi M. Deployment and exploitation of nanotechnology nanomaterials and nanomedicine. In: AIP conference proceedings 2018; 1990.Google Scholar
  37. 37.
    Dube A, Ebrahim N. The nanomedicine landscape of South Africa. Nanotechnol Rev. 2017;6(4):339–44.CrossRefGoogle Scholar
  38. 38.
    Arcuri ASA, Grossi MGL, Pinto VRS, Rinaldi A, Pinto AC. Developing strategies in Brazil to manage the emerging nanotechnology and its associated risks. In: Linkov I, Steevens J, editors. Dordrecht: Springer; 2009. p. 299–309.Google Scholar
  39. 39.
    Jarvis SL, Richmond N. Regulation and governance of nanotechnology in China: regulatory challenges and effectiveness. Eur J Law Technol. 2011;2(3).Google Scholar
  40. 40.
    Bhatia P, Chugh A. A multilevel governance framework for regulation of nanomedicine in India. Nanotechnol Rev. 2017;6(4):373–82.CrossRefGoogle Scholar
  41. 41.
    Bhatia P, Vasaikar S, Wali A. A landscape of nanomedicine innovations in India. Nanotechnol Rev. 2018;7(2):131–48.CrossRefGoogle Scholar
  42. 42.
    Mishra M, Dashora K, Srivastava A, Fasake VD, Nag RH. Prospects, challenges and need for regulation of nanotechnology with special reference to India. Ecotoxicol Environ Saf. 2019;171:677–82.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Caitlin Lazurko
    • 1
    • 2
  • Manuel Ahumada
    • 3
  • Emilio I. Alarcon
    • 1
    • 2
  • Erik Jacques
    • 1
    Email author
  1. 1.Division of Cardiac SurgeryUniversity of Ottawa Heart InstituteOttawaCanada
  2. 2.Department of Biochemistry, Microbiology, and Immunology, Faculty of MedicineUniversity of OttawaOttawaCanada
  3. 3.Facultad de CienciasCentro de Nanotecnología Aplicada, Universidad MayorHuechuraba, RMChile

Personalised recommendations