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The Regulatory Landscape of New Health Technologies and Nanotechnologies: The Role of Complexity of Nanosystems

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GeNeDis 2022 (GeNeDis 2022)

Part of the book series: Advances in Experimental Medicine and Biology ((AEMB,volume 1425))

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Abstract

Herein we present the modern issue of new health technologies that emerge in Medicine and Therapeutics, with regard to their development, regulatory framework, approval, and post-approval monitoring. The European law and legislation distinguish the various subcategories of health technologies in medicinal products, medical devices, biotechnological products, advanced therapy medicinal products, and nanomedicinal products. Each of these categories presents its own distinctive characteristics, based on principles that regard the development technology and intended therapeutic use, and, as a result, is defined by a unique regulatory framework inside the European legislation environment. New health technologies are a key of twenty-first-century knowledge, science, and economy and a part of society growth and economic development, while at the same time they present significant challenges, mainly through matters that regard their safety, efficacy, and value for the public. In this environment, the concept of complexity of living and artificial systems arises, as part of their nature, but also as a perspective that will give answers regarding their dynamic behavior, evolution, and overall quality.

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References

  1. Rushefsky ME, Patel K (2002) Health care policy in an age of new technologies. Taylor & Francis Group, Oxfordshire

    Google Scholar 

  2. Webster A (2006) New technologies in health care: challenge, change and innovation. Palgrave Macmillan, New York

    Book  Google Scholar 

  3. Rizzo AS, Bouchard S (2019) Virtual reality for psychological and neurocognitive interventions. Springer, New York

    Book  Google Scholar 

  4. Flear ML, Farrell AM, Hervey TK, Murphy T (2013) European law and new health technologies. Oxford University Press, Oxford

    Book  Google Scholar 

  5. OECD (2017) New health technologies: managing access, value and sustainability. OECD Publishing, Paris

    Book  Google Scholar 

  6. EMA. Advanced therapy medicinal products: overview. https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview#committee-for-advanced-therapies-section. Accessed 12 June 2020

  7. EMA. Innovation in medicines. https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines. Accessed 12 June 2020

  8. Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ L 88, 4.4.2011, pp 45–65

    Google Scholar 

  9. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, pp 67–128

    Google Scholar 

  10. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, pp 1–43

    Google Scholar 

  11. EMA. ICH S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals. https://www.ema.europa.eu/en/ich-s6-r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals. Accessed 4 June 2020

  12. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance), OJ L 136, 30.4.2004, pp 1–33

    Google Scholar 

  13. EMA. Multidisciplinary: nanomedicines. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-nanomedicines. Accessed 12 June 2020

  14. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance), OJ L 50, 20.2.2004, pp 44–59

    Google Scholar 

  15. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance), OJ L 50, 20.2.2004, pp 28–43

    Google Scholar 

  16. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1.5.2001, pp 34–44

    Google Scholar 

  17. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products (Text with EEA relevance), OJ L 91, 9.4.2005, pp 13–19

    Google Scholar 

  18. EMA. Non-clinical guidelines. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/non-clinical-guidelines. Accessed 31 May 2020

  19. Kosta E, Bowman DM (2011) Treating or tracking? Regulatory challenges of nano-enabled ICT implants. Law Policy 33:256–260

    Article  Google Scholar 

  20. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281, 23.11.1995, pp 31–50

    Google Scholar 

  21. European Convention on Human Rights and Fundamental Freedoms, Art 8

    Google Scholar 

  22. OECD. OECD guidelines on the protection of privacy and transborder flows of personal data (OECD, 23 September 1980). www.oecd.org/document/18/0,2340,en_2649_34255_1815186_1_1_1_1,00.html. Accessed 31 May 2020

  23. EMA. Authorisation of medicines. https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines. Accessed 31 May 2020

  24. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189, 20.7.1990, pp 17–36

    Google Scholar 

  25. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331, 7.12.1998, pp 1–37

    Google Scholar 

  26. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products Text with EEA relevance, OJ L 348, 31.12.2010, pp 1–16

    Google Scholar 

  27. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Text with EEA relevance, OJ L 348, 31.12.2010, pp 74–99

    Google Scholar 

  28. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance), OJ L 324, 10.12.2007, pp 121–137

    Google Scholar 

  29. Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007–2013) Statements by the Commission, OJ L 412, 30.12.2006, pp 1–43

    Google Scholar 

  30. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213, 30.7.1998, pp 13–21

    Google Scholar 

  31. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 102, 7.4.2004, pp 48–58

    Google Scholar 

  32. EMA. Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework, EMEA/P/24143/2004 Rev. 1 corr, 18 March 2009

    Google Scholar 

  33. EMA. ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals, EMA/CPMP/ICH/286/1995, December 2009

    Google Scholar 

  34. EMA. Guideline for good clinical practice E6(R2) Step 5, EMA/CHMP/ICH/135/1995, 1 December 2016

    Google Scholar 

  35. Wong AYT, Mahalatchimy A (2018) Human stem cells patents-emerging issues and challenges in Europe, United States, China, and Japan. J World Intellect Prop 21:1–30

    Article  Google Scholar 

  36. Liddicoat J, Liddell K, McCarthy AH et al (2019) Continental drift? Do European clinical genetic testing laboratories have a patent problem? Eur J Hum Genet 27:997–1007

    Article  PubMed  PubMed Central  Google Scholar 

  37. EC. Advanced therapies. https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview Accessed 8 June 2020

  38. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance), OJ L 242, 15.9.2009, pp 3–12

    Google Scholar 

  39. EC. Guidelines on good manufacturing practice specific to advanced therapy medicinal products, C(2017) 7694 final, 22.11.2017

    Google Scholar 

  40. EC. Good clinical practice specific to advanced therapy medicinal products, C(2019) 7140 final, 10.10.2019

    Google Scholar 

  41. EMA. Committee for Advanced Therapies (CAT). https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat#comment-38087. Accessed 7 June 2020

  42. EMA. Advanced therapy classification. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification. Accessed 8 June 2020

  43. EMA. Reflection paper on classification of advanced therapy medicinal products, EMA/CAT/600280/2010 Rev.1, 20 June 2014

    Google Scholar 

  44. Iglesias-López C, Agustí A, Obach M, Vallano A (2019) Regulatory framework for advanced therapy medicinal products in Europe and United States. Front Pharmacol 10:921

    Article  PubMed  PubMed Central  Google Scholar 

  45. EMA. Reflection paper on stem cell-based medicinal products, EMA/CAT/571134/2009, 16 March 2010

    Google Scholar 

  46. Yu TTL, Gupta P, Ronfard V, Vertès AA, Bayon Y (2018) Recent progress in European advanced therapy medicinal products and beyond. Front Bioeng Biotechnol 6:130

    Article  PubMed  PubMed Central  Google Scholar 

  47. Abou-El-Enein M, Elsanhoury A, Reinke P (2016) Overcoming challenges facing advanced therapies in the EU market. Cell Stem Cell 19:293–297

    Article  CAS  PubMed  Google Scholar 

  48. Ten Ham RMT, Hoekman J, Hövels AM, Broekmans AW, Leufkens HGM, Klungel OH (2018) Challenges in advanced therapy medicinal product development: a survey among companies in Europe. Mol Ther Methods Clin Dev 11:121–130

    Article  PubMed  PubMed Central  Google Scholar 

  49. EMA. Support for advanced-therapy developers. https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/support-advanced-therapy-developers. Accessed 13 June 2020

  50. Commission Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’ (Text with EEA relevance), C/2018/3193, OJ L 132, 30.5.2018, pp 1–4

    Google Scholar 

  51. EMA. Nanotechnology. https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview. Accessed 10 June 2020

  52. Commission Recommendation of 18 October 2011 on the definition of nanomaterial Text with EEA relevance, OJ L 275, 20.10.2011, pp 38–40

    Google Scholar 

  53. Li Z, Tan S, Li S, Shen Q, Wang K (2017) Cancer drug delivery in the nano era: an overview and perspectives (Review). Oncol Rep 38:611–624

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  54. EMA. Ad hoc CHMP Expert Group Meeting on ‘Nanomedicines’. https://www.ema.europa.eu/en/events/ad-hoc-chmp-expert-group-meeting-nanomedicines. Accessed 11 June 2020

  55. Farjadian F, Ghasemi A, Gohari O, Roointan A, Karimi M, Hamblin MR (2019) Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities. Nanomedicine (London) 14:93–126

    Article  CAS  Google Scholar 

  56. Demetzos C, Pippa N (2014) Advanced drug delivery nanosystems (aDDnSs): a mini-review. Drug Deliv 21:250–257

    Article  CAS  PubMed  Google Scholar 

  57. Naziris N, Pippa N, Pispas S, Demetzos C (2016) Stimuli-responsive drug delivery nanosystems: from bench to clinic. Curr Nanomed 6:1–20

    Article  Google Scholar 

  58. Soares S, Sousa J, Pais A, Vitorino C (2018) Nanomedicine: principles, properties, and regulatory issues. Front Chem 6:360

    Article  PubMed  PubMed Central  Google Scholar 

  59. European Parliament. Parliamentary questions, Question for written answer E-000731-19 to the Commission, Rule 130. https://www.europarl.europa.eu/doceo/document/E-8-2019-000731_EN.html. Accessed 10 June 2020

  60. Ehmann F, Sakai-Kato K, Duncan R, Pérez H, de la Ossa D, Pita R, Vidal JM, Kohli A, Tothfalusi L, Sanh A, Tinton S, Robert JL, Silva LB, Amati MP (2013) Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines. Nanomedicine (London) 8:849–856

    Article  CAS  Google Scholar 

  61. EMA. Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product, EMA/CHMP/806058/2009/Rev. 02, 21 February 2013

    Google Scholar 

  62. EMA. Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products, EMA/325027/2013, 22 May 2013

    Google Scholar 

  63. EMA. Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products, EMA/CHMP/13099/2013, 19 December 2013

    Google Scholar 

  64. EMA. Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product, EMA/CHMP/SWP/620008/2012, 26 March 2015

    Google Scholar 

  65. Demetzos C (2015) Biophysics and thermodynamics: the scientific building blocks of bio-inspired drug delivery nano systems. AAPS PharmSciTech 16:491–495

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  66. Naziris N, Pippa N, Pispas S, Demetzos C (2017) Thermal analysis of liposomal formulation as element to evaluate their effectiveness as drug and vaccine delivery systems. In: Pearson BR (ed) Liposomes: historical, clinical, and molecular perspectives. Nova Science Publishers, New York, pp 265–318

    Google Scholar 

  67. Demetzos C, Pippa N (2015) Fractal geometry as a new approach for proving nanosimilarity: a reflection note. Int J Pharm 483:1–5

    Article  CAS  PubMed  Google Scholar 

  68. Naziris N, Chountoulesi M, Stavrinides S, Hanias M, Demetzos C (2022) Chaotic dynamics and stability of liposomal nanosystems. Curr Nanosci 18:375–390

    Article  CAS  Google Scholar 

  69. Naziris N, Pippa N, Pispas S, Demetzos C (2017) The role of the information/entropy balance in self-assembly. The structural hierarchy of chimeric drug delivery nanosystems. Pharmakeftiki 29:77–82

    Google Scholar 

  70. Demetzos C (2021) Nanoplatforms as information carriers and thermodynamic epitopes, in neurodegenerative and immune diseases. In: Vlamos P et al (eds) Handbook of computational neurodegeneration. Springer Nature, Cham, pp 1–13

    Google Scholar 

  71. Shannon CE (1948) A mathematical theory of communication. Bell Syst Techn J 27:379–423

    Article  Google Scholar 

  72. Demetzos C, Vlamos P, Vlachakis D (2022) Perspectives to fight viruses. The example of SARS-CoV-2. Proc Eur Acad Sci Arts 1:1–6

    Google Scholar 

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Authors and Affiliations

  1. Section of Pharmaceutical Technology, Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece

    Nikolaos Naziris & Costas Demetzos

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  1. Nikolaos Naziris
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  2. Costas Demetzos
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Correspondence to Nikolaos Naziris .

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  1. Department of Informatics, Ionian University, Corfu, Greece

    Panagiotis Vlamos

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Naziris, N., Demetzos, C. (2023). The Regulatory Landscape of New Health Technologies and Nanotechnologies: The Role of Complexity of Nanosystems. In: Vlamos, P. (eds) GeNeDis 2022. GeNeDis 2022. Advances in Experimental Medicine and Biology, vol 1425. Springer, Cham. https://doi.org/10.1007/978-3-031-31986-0_56

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