Future perspectives for advancing regulatory science of nanotechnology-enabled health products

Halamoda-Kenzaoui, Blanka; Geertsma, Robert E.; Pouw, Joost Jacob; Prina‐Mello, Adriele; Carrer, Moreno; Roesslein, Matthias; Sips, A. J. A. M.; Weltring, Klaus-Michael; Spring, Kathleen; Bremer‐Hoffmann, Susanne

doi:10.1007/s13346-022-01165-y

Cited by 15 publications

(8 citation statements)

References 13 publications

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“…This information needs to take into account nano-speci c considerations, although the extent to which this is speci ed in regulatory guidance documents differs between regulatory frameworks. In general, standard methods for regulatory preclinical quality and safety studies that are compatible with nanomaterials do not always exist, but various initiatives are addressing this issue already, such as OECD's Working Party on Manufactured Nanomaterials and EU H2020 projects REFINE-NANOMED [39] and GRACIOUS [40][41][42].…”

Section: Discussionmentioning

confidence: 99%

Regulatory aspects of a nanomaterial for imaging therapeutic cells

Zee

Vries

Masa

et al. 2022

Preprint

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The ability to track therapeutic cells upon administration to the patient is of interest to both regulators and developers of cell therapy. The European Commission Horizon2020 project nTRACK from 2017-2022 aimed to develop a multi-modal nano-imaging agent to track therapeutic cells during development of a cell therapy. As part of this project, we investigated the regulatory pathway involved for such a product. An important regulatory hurdle appeared to be the appropriate regulatory classification the nTRACK nano-imaging agent, as neither the definition for medicinal product nor the definition for medical device were a good fit for the purpose of the product. As a consequence, the information requirements to fulfill before conducting a First in Human trial are not evident and can only be decided upon by closely collaborating and communicating with the relevant authorities throughout the development of the product. Moreover, standard test methods for demonstrating the quality and safety of a medicinal product or medical device are not always suitable for nanomaterials such as the nTRACK nano-imaging agent. Regulatory agility is therefore a great need to prevent delay of promising medical innovations, although regulatory guidance on these products will likely improve with more experience. In this article, we outline the lessons learnt related to the regulatory process of the nTRACK nano-imaging agent for tracking therapeutic cells and offer recommendations to both regulators and developers of similar products.

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Section: Discussionmentioning

confidence: 99%

Regulatory aspects of a nanomaterial for imaging therapeutic cells

Zee

Vries

Masa

et al. 2022

Preprint

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“…The European Medicines Agency (EMA) has an Expert Working Group that has released some reflection papers for particular nanomedicines to guide marketing authorization applications (Hertig et al 2021 ). However, it is still unclear whether the existing regulatory frameworks will pose challenges in future innovative nanomedicine development (Halamoda-Kenzaoui et al 2022 ). The uncertainties related to the regulatory processes involving nanomedicines are presented in Fig.…”

Section: Considerations In Nanomedicine Developmentmentioning

confidence: 99%

Nanomedicine-based commercial formulations: current developments and future prospects

Thapa

Kim

2022

J. Pharm. Investig.

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Background In recent decades, there has been a considerable increase in the number of nanomedicine-based formulations, and their advantages, including controlled/targeted drug delivery with increased efficacy and reduced toxicity, make them ideal candidates for therapeutic delivery in the treatment of complex and difficult-to-treat diseases, such as cancer. Areas covered This review focuses on nanomedicine-based formulation development, approved and marketed nanomedicines, and the challenges faced in nanomedicine development as well as their future prospects. Expert opinion To date, the Food and Drug Administration and the European Medicines Agency have approved several nanomedicines, which are now commercially available. However, several critical challenges, including reproducibility, proper characterization, and biological evaluation, e.g., via assays, are still associated with their use. Therefore, rigorous studies alongside stringent guidelines for effective and safe nanomedicine development and use are still warranted. In this study, we provide an overview of currently available nanomedicine-based formulations. Thus, the findings here reported may serve as a basis for further studies regarding the use of these formulations for therapeutic purposes in near future.

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“…There is a clear identification by EMA as a regulatory science research need, the one to develop an understanding of, and regulatory response to, nanotechnology and new materials in pharmaceuticals anticipated to be used in the coming 10 years [ 69 ]. Even if a fervent activity is noted across stakeholders as evidenced by the recent results of the Refine project in terms of future perspectives for advancing regulatory science of nanotechnology-enabled health products [ 70 ], it is still missing a dedicated discussion on the impact of nanotechnology innovation in the assessment of CTs. Nevertheless, there is a current activity carried out in the context of the EU innovation network horizon scanning with a topic proposal on nanotechnology, where hopefully this issue may emerge.…”

Section: Critical Quality Attributesmentioning

confidence: 99%

Nanomedicines and nanocarriers in clinical trials: surfing through regulatory requirements and physico-chemical critical quality attributes

Dri

Rinaldi

Carafa

et al. 2022

Drug Deliv. and Transl. Res.

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Elucidation of physical-chemical characteristics of investigational medicinal products should be established with suitable methodology. Characterization of nanomedicines and nanocarriers in clinical trials may require the definition of additional specific properties depending on the nature of the nanostructures or nanomaterials composing the investigational medicinal product. The availability of regulatory requirements and guidelines is investigated focusing on critical quality attributes for nanomedicines and nanocarriers, mapping them in a clinical trial setting. Current regulatory challenges and issues are highlighted. The increasing complexity of nanostructures, the innovative connotation of applied nanotechnology, and the lack in capillarity or misalignment of relevant guidelines and terminology may lead to a potential not standardized approach in the characterization of nanomedicines and nanocarriers in clinical trials and delays in the approval process. Further efforts and a proactive approach from a regulatory standpoint would be desirable to surf the wave of innovation that impact nanomedicines and nanocarriers in clinical trials, in order to support clinical drug development capitalizing on technological advances and still ensuring a strong regulatory framework. Graphical Abstract

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Future perspectives for advancing regulatory science of nanotechnology-enabled health products

Cited by 15 publications

References 13 publications

Regulatory aspects of a nanomaterial for imaging therapeutic cells

Regulatory aspects of a nanomaterial for imaging therapeutic cells

Nanomedicine-based commercial formulations: current developments and future prospects

Nanomedicines and nanocarriers in clinical trials: surfing through regulatory requirements and physico-chemical critical quality attributes

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