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2019 | OriginalPaper | Chapter

10. Regulatory Normative of Nanomaterials for Their Use in Biomedicine

Authors : Caitlin Lazurko, Manuel Ahumada, Emilio I. Alarcon, Erik Jacques

Published in: Nanoengineering Materials for Biomedical Uses

Publisher: Springer International Publishing

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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.

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Literature
1.
go back to reference Larsson S, Jansson M, Boholm Å. Expert stakeholders’ perception of nanotechnology: risk, benefit, knowledge, and regulation. J Nanopart Res. 2019;21(3):57.CrossRef Larsson S, Jansson M, Boholm Å. Expert stakeholders’ perception of nanotechnology: risk, benefit, knowledge, and regulation. J Nanopart Res. 2019;21(3):57.CrossRef
2.
go back to reference 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.CrossRef 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.CrossRef
3.
go back to reference Bowman DM, Hodge GA. Nanotechnology: mapping the wild regulatory frontier. Futures. 2006;38(9):1060–73.CrossRef Bowman DM, Hodge GA. Nanotechnology: mapping the wild regulatory frontier. Futures. 2006;38(9):1060–73.CrossRef
12.
go back to reference 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.CrossRef 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.CrossRef
14.
go back to reference 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. 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.
15.
go back to reference Pita R, Ehmann F, Papaluca M. Nanomedicines in the EU—regulatory overview. AAPS J. 2016;18(6):1576–82.CrossRef Pita R, Ehmann F, Papaluca M. Nanomedicines in the EU—regulatory overview. AAPS J. 2016;18(6):1576–82.CrossRef
16.
go back to reference 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.CrossRef 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.CrossRef
17.
go back to reference 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.CrossRef 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.CrossRef
18.
go back to reference Soares S, Sousa J, Pais A, Vitorino C. Nanomedicine: principles, properties, and regulatory issues. Front Chem. 2018;6:1–15.CrossRef Soares S, Sousa J, Pais A, Vitorino C. Nanomedicine: principles, properties, and regulatory issues. Front Chem. 2018;6:1–15.CrossRef
19.
go back to reference 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. 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.
20.
go back to reference Trisolino A. Nanomedicine: building a bridge between science and law. NanoEthics. 2014;8(2):141–63.CrossRef Trisolino A. Nanomedicine: building a bridge between science and law. NanoEthics. 2014;8(2):141–63.CrossRef
21.
go back to reference 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. 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.
22.
go back to reference 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.CrossRef 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.CrossRef
23.
go back to reference Kreyling WG, Semmler-Behnke M, Chaudhry Q. A complementary definition of nanomaterial. Nano Today. 2010;5(3):165–8.CrossRef Kreyling WG, Semmler-Behnke M, Chaudhry Q. A complementary definition of nanomaterial. Nano Today. 2010;5(3):165–8.CrossRef
24.
go back to reference Taniguchi N. On the basic concept of nano-technology. In: Proceedings of international conference on production engineering. London; 1974. Taniguchi N. On the basic concept of nano-technology. In: Proceedings of international conference on production engineering. London; 1974.
25.
go back to reference Iijima S. Helical microtubules of graphitic carbon. Nature. 1991;354(6348):56–8.CrossRef Iijima S. Helical microtubules of graphitic carbon. Nature. 1991;354(6348):56–8.CrossRef
27.
go back to reference 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. 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.
28.
go back to reference Strategy CfRaD. Nanotechnology and materials R&D in Japan (2018): an overview and analysis. In: Unit NM, editor. 2018. p. 86. Strategy CfRaD. Nanotechnology and materials R&D in Japan (2018): an overview and analysis. In: Unit NM, editor. 2018. p. 86.
29.
go back to reference 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. 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.
31.
go back to reference Office C. The 5th science and technology basic plan. In: Office C, editor. 2016. Office C. The 5th science and technology basic plan. In: Office C, editor. 2016.
32.
go back to reference Žagar A. Nanotech cluster and industry landscape in Japan. 2014. Žagar A. Nanotech cluster and industry landscape in Japan. 2014.
36.
go back to reference 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. 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.
37.
go back to reference Dube A, Ebrahim N. The nanomedicine landscape of South Africa. Nanotechnol Rev. 2017;6(4):339–44.CrossRef Dube A, Ebrahim N. The nanomedicine landscape of South Africa. Nanotechnol Rev. 2017;6(4):339–44.CrossRef
38.
go back to reference 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. 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.
39.
go back to reference Jarvis SL, Richmond N. Regulation and governance of nanotechnology in China: regulatory challenges and effectiveness. Eur J Law Technol. 2011;2(3). Jarvis SL, Richmond N. Regulation and governance of nanotechnology in China: regulatory challenges and effectiveness. Eur J Law Technol. 2011;2(3).
40.
go back to reference Bhatia P, Chugh A. A multilevel governance framework for regulation of nanomedicine in India. Nanotechnol Rev. 2017;6(4):373–82.CrossRef Bhatia P, Chugh A. A multilevel governance framework for regulation of nanomedicine in India. Nanotechnol Rev. 2017;6(4):373–82.CrossRef
41.
go back to reference Bhatia P, Vasaikar S, Wali A. A landscape of nanomedicine innovations in India. Nanotechnol Rev. 2018;7(2):131–48.CrossRef Bhatia P, Vasaikar S, Wali A. A landscape of nanomedicine innovations in India. Nanotechnol Rev. 2018;7(2):131–48.CrossRef
42.
go back to reference 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.CrossRef 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.CrossRef
Metadata
Title
Regulatory Normative of Nanomaterials for Their Use in Biomedicine
Authors
Caitlin Lazurko
Manuel Ahumada
Emilio I. Alarcon
Erik Jacques
Copyright Year
2019
DOI
https://doi.org/10.1007/978-3-030-31261-9_10

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