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Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory “Astrolabe” Inspired System

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Abstract

The application of the nanotechnology in medicine and pharmaceutics opens new horizons in therapeutics. Several nanomedicines are in the market and an increasing number is in clinical trials. But which is the advantage of the medicines in nanoscale? The scientists and the regulatory authorities agree that the size and consequently the physiochemical/biological properties of nanomaterials play a key role in their safety and effectiveness. Additionally, all of them agree that a new scientific-based regulatory landscape is required for the establishment of nanomedicines in the market. The aim of this review is to investigate the parameters that the scientists and the regulatory authorities should take into account in order to build up a dynamic regulatory landscape for nanomedicines. For this reason, we propose an “astrolabe-like system” as the guide for establishing the regulatory approval process. Its function is based on the different physicochemical/biological properties in comparison to low molecular weight drugs.

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Scheme 1
Fig. 1

Notes

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    European Medicines Agency (EMA), 2006. EMEA/CHMP/79769/2006. Reflection paper on nanotechnology-based medicinal products for human use (29 June). http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_ guideline/2010/01/WC500069728.pdf, Accessed date: 20 August 2018.

  2. 2.

    This “White paper” states the situation of nanomedicines and nanosimilars and suggests new scientific directions that should be considered towards a harmonized regulatory pathway.

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Correspondence to Costas Demetzos.

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“Astrolabe” was an ancient device that has been used as navigator. The Astrolabe is a complex instrument that investigates and discloses the meaning of multicomplex phenomena with precision by using its dynamic and multifunctional abilities (Scheme 1).

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Demetzos, C., Kavatzikidou, P., Pippa, N. et al. Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory “Astrolabe” Inspired System. AAPS PharmSciTech 21, 65 (2020) doi:10.1208/s12249-019-1573-y

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KEY WORDS

  • astrolabe
  • nanomedicines
  • nanosimilars
  • regulatory issues
  • complex drugs