Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety

doi:10.3389/fphar.2021.787239

. 2022 Feb 24:12:787239.

doi: 10.3389/fphar.2021.787239. eCollection 2021.

Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety

Michael P Isles¹

Affiliations

PMID: 35280250
PMCID: PMC8907565
DOI: 10.3389/fphar.2021.787239

Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety

Michael P Isles. Front Pharmacol. 2022.

. 2022 Feb 24:12:787239.

doi: 10.3389/fphar.2021.787239. eCollection 2021.

Author

Michael P Isles¹

Affiliation

¹ European Alliance for Access to Safe Medicines, Dublin, Ireland.

PMID: 35280250
PMCID: PMC8907565
DOI: 10.3389/fphar.2021.787239

No abstract available

Keywords: advocacy program; centralised regulatory procedure; follow-on products; hybrid application; nanomedicines; nanosimilars.

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Conflict of interest statement

The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

**FIGURE 1**
Number of nanomaterial product applications submitted to CDER by year. Applications are separated as INDs, NDAs, and ANDAs.

See this image and copyright information in PMC

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References

1. Agüera M. L., Martin-Malo A., Alvarez-Lara M. A., Garcia-Montemayor V. E., Canton P., Soriano S., et al. (2015). Efficiency of Original Versus Generic Intravenous Iron Formulations in Patients on Haemodialysis. PLoS One 10 (10), 8. 10.1371/journal.pone.0135967 - DOI - PMC - PubMed
1. Bremer-Hoffmann S., Halamoda-Kenzaoui B., Borgos S. E. (2018). Identification of Regulatory Needs for Nanomedicines J. Interdiscip. Nanomedicine 3. 10.1002/jin2.34 - DOI - PubMed
1. Ehmann F., Sakai-Kato K., Duncan R., Hernán Pérez de la Ossa D., Pita R., Vidal J. M., et al. (2013). Next-Generation Nanomedicines and Nanosimilars: EU Regulators' Initiatives Relating to the Development and Evaluation of Nanomedicines. Nanomedicine (Lond). 8 (5), 849–856. 10.2217/nnm.13.68 - DOI - PubMed
1. European Medicines Agency (2015). Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-p... .
1. Event summary (2019). Event Summary: Handling Innovation in NANOMEDICINES: Regulatory Challenges and Opportunities in Modern Healthcare. Available at: https://eaasm.eu/en-gb/2019/04/04/event-summary-handling-innovation-in-n... .

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[1] Agüera M. L., Martin-Malo A., Alvarez-Lara M. A., Garcia-Montemayor V. E., Canton P., Soriano S., et al. (2015). Efficiency of Original Versus Generic Intravenous Iron Formulations in Patients on Haemodialysis. PLoS One 10 (10), 8. 10.1371/journal.pone.0135967 - DOI - PMC - PubMed

[2] Agüera M. L., Martin-Malo A., Alvarez-Lara M. A., Garcia-Montemayor V. E., Canton P., Soriano S., et al. (2015). Efficiency of Original Versus Generic Intravenous Iron Formulations in Patients on Haemodialysis. PLoS One 10 (10), 8. 10.1371/journal.pone.0135967 - DOI - PMC - PubMed

[3] Bremer-Hoffmann S., Halamoda-Kenzaoui B., Borgos S. E. (2018). Identification of Regulatory Needs for Nanomedicines J. Interdiscip. Nanomedicine 3. 10.1002/jin2.34 - DOI - PubMed

[4] Bremer-Hoffmann S., Halamoda-Kenzaoui B., Borgos S. E. (2018). Identification of Regulatory Needs for Nanomedicines J. Interdiscip. Nanomedicine 3. 10.1002/jin2.34 - DOI - PubMed

[5] Ehmann F., Sakai-Kato K., Duncan R., Hernán Pérez de la Ossa D., Pita R., Vidal J. M., et al. (2013). Next-Generation Nanomedicines and Nanosimilars: EU Regulators' Initiatives Relating to the Development and Evaluation of Nanomedicines. Nanomedicine (Lond). 8 (5), 849–856. 10.2217/nnm.13.68 - DOI - PubMed

[6] Ehmann F., Sakai-Kato K., Duncan R., Hernán Pérez de la Ossa D., Pita R., Vidal J. M., et al. (2013). Next-Generation Nanomedicines and Nanosimilars: EU Regulators' Initiatives Relating to the Development and Evaluation of Nanomedicines. Nanomedicine (Lond). 8 (5), 849–856. 10.2217/nnm.13.68 - DOI - PubMed

[7] European Medicines Agency (2015). Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-p... .

[8] European Medicines Agency (2015). Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-p... .

[9] Event summary (2019). Event Summary: Handling Innovation in NANOMEDICINES: Regulatory Challenges and Opportunities in Modern Healthcare. Available at: https://eaasm.eu/en-gb/2019/04/04/event-summary-handling-innovation-in-n... .

[10] Event summary (2019). Event Summary: Handling Innovation in NANOMEDICINES: Regulatory Challenges and Opportunities in Modern Healthcare. Available at: https://eaasm.eu/en-gb/2019/04/04/event-summary-handling-innovation-in-n... .

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Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety

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Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety

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