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. 2022 Jul 9;14(7):1438.
doi: 10.3390/pharmaceutics14071438.

Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office

Diego Alejandro Dri  1   2 , Elisa Gaucci  1 , Ilaria Torrieri  2 , Maria Carafa  2 , Carlotta Marianecci  2 , Donatella Gramaglia  1
Affiliations

Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office

Diego Alejandro Dri et al. Pharmaceutics. .

Abstract

Investigational medicinal products submitted over the course of 3 years and authorized at the Clinical Trials Office of the Italian Medicines Agency as part of a request for authorization of clinical trials were scrutinized to identify those encompassing nanomedicines. The quality assessment reports performed on the documentation submitted were analyzed, classifying and discussing the most frequently detected issues. The identification of nanomedicines retrieved and the information on their quality profiles are shared to increase the transparency and availability of information, providing feedback that can support sponsors in optimizing the quality part of the documentation and of the information submitted. Results confirm that nanomedicines tested as investigational medicinal products in clinical trials are developed and authorized in agreement with the highest standards of quality, meeting safety profiles according to the strong regulatory requirements in the European Union. Some key points are highlighted and indicate that the regulatory approach to innovation in a clinical trial setting could potentially be renewed to ride the wave of innovation, particularly in the nanotechnology field, capitalizing on lessons learned and still ensuring a strong and effective framework.

Keywords: clinical trials; investigational medicinal products; nanocarrier; nanomedicine; quality; regulatory.

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Conflict of interest statement

The authors declare no conflict of interest. The conflict-of-interest declaration of the authors 1 is in accordance with the conflict-of-interest regulations approved by the AIFA Board of Directors (Resolution n. 37 dated 13 October 2020). The view and opinions expressed are those of the individual authors 1 and should not be attributed to the AIFA.

Figures

Figure 1
Figure 1
Number of CTs authorized per year at the CTO from 2018 to 2020.
Figure 2
Figure 2
Percentage of commercial and non-commercial CTs assessed and authorized from 2018 to 2020, including a nanomedicine tested as an IMP.
Figure 3
Figure 3
Categories attributable to nanomedicines identified in CTs assessed and authorized from 2018 to 2020.
Figure 4
Figure 4
Distribution of therapeutic areas of CTs, including a nanomedicine tested as an IMP, assessed and authorized from 2018 to 2020.
Figure 5
Figure 5
Number of quality issues combining drug substance (DS) and drug product (DP) classification label in CTs involving nanomedicines, assessed and authorized from 2018 to 2020.
See this image and copyright information in PMC

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