Regulatory Normative of Nanomaterials for Their Use in Biomedicine
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.
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.
All authors have read and approved the final version.
- 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.Nanotechnology task force. https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-task-force (2019). Accessed 23 May 2019.
- 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.
- 7.2013 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.Research on nanomaterials. https://www.epa.gov/chemical-research/research-nanomaterials (2019). Accessed 24 May 2019.
- 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.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.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.
- 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.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
- 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
- 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
- 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
- 24.Taniguchi N. On the basic concept of nano-technology. In: Proceedings of international conference on production engineering. London; 1974.Google Scholar
- 26.StatNano. Japan indicators. https://statnano.com/country/japan (2019). Accessed 25 May 2019.
- 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.Strategy CfRaD. Nanotechnology and materials R&D in Japan (2018): an overview and analysis. In: Unit NM, editor. 2018. p. 86.Google Scholar
- 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.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.Office C. The 5th science and technology basic plan. In: Office C, editor. 2016.Google Scholar
- 32.Žagar A. Nanotech cluster and industry landscape in Japan. 2014.Google Scholar
- 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.Worldometers. Japan population. https://www.worldometers.info/world-population/japan-population/ (2019). Accessed 29 May 2019.
- 35.Bank TW. Japan. In data https://data.worldbank.org/country/japan (2019). Accessed 29 May 2019.
- 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
- 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.Jarvis SL, Richmond N. Regulation and governance of nanotechnology in China: regulatory challenges and effectiveness. Eur J Law Technol. 2011;2(3).Google Scholar