Nanomedicines and off patent follow-on medicines (nanosimilars) EMA regulatory procedures overview
Author:
Affiliation:
1. REPLEK FARM Ltd, Kozle 188, 1000 Skopje, Republic of North Macedonia
Publisher
Macedonian Pharmaceutical Association
Subject
General Engineering,Energy Engineering and Power Technology
Link
https://bulletin.mfd.org.mk/volumes/Volume%2069_3/69_3_034.pdf
Reference6 articles.
1. European Alliance for Access to Safe Medicines (EAASM), 2020. Patient Safety and Nanomedicines - The need for a centralized regulatory procedure. www.eaasm.eu
2. Flühmann B., Prithviraj R., 2019. Nanomedicines & Nanosimilars: Implications for Regulators, Payers, and Prescribers; Proceedings of the Summary of Key Discussion Points from DIA Europe; Viena, Austria. 5–7.
3. Hertig, J. B., Shah, V. P., Flühmann, B., Mühlebach, S., Stemer, G., Surugue, J., Moss, R., & Di Francesco, T., 2021. Tackling the challenges of nanomedicines: are we ready? American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists, 78(12), 1047–1056. https://doi.org/10.1093/ajhp/zxab04
4. Hussaarts, L. et al., 2017. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Annals of the New York Academy of Sciences, 1407(1), 39–49. https://doi.org/10.1111/nyas.13347
5. Klein, K. et al., 2019. The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations. European journal of pharmaceutical sciences: official journal of the European Federation for Pharmaceutical Sciences, 133,228–235. https://doi.org/10.1016/j.ejps.2019.03.029
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