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Current Pharmaceutical Design

Editor-in-Chief

ISSN (Print): 1381-6128
ISSN (Online): 1873-4286

Review Article

Development of Nanomedicines and Nano-Similars: Recent Advances in Regulatory Landscape

Author(s): Rishi Paliwal*, Pramod Kumar*, Akash Chaurasiya, Rameshroo Kenwat, Sumeet Katke and Shivani R. Paliwal

Volume 28, Issue 2, 2022

Published on: 09 December, 2021

Page: [165 - 177] Pages: 13

DOI: 10.2174/1381612827666211115170001

Price: $65

Abstract

Background: Nanopharmaceuticals serve as emerging forms of modern medicines, which include nanomedicines, nanosimilars, nanotheranostics, nanodevices, and many more. In the last two decades, a large number of nano-based products have reached the market and are being used clinically.

Objectives: Unlike conventional pharmaceutical products, nanopharmaceuticals behave differently both in vitro and in vivo, and therefore, the development of their generic versions needs special attention to replicate the similar drug release pattern leading to an identical therapeutic outcome. Further, drug-device combinations and 3D products are the latest advancements in precision medicine delivery and development.

Methods: The regulatory guidelines for these products are being framed at many stages by various regulatory agencies like USFDA/EMA and still are in infancy at the moment if we look at wider perspectives and applications of nanomedicine.

Results: For a formulation scientist, it is much needed that well-explained and directive guidelines should be made available before leading to the development of the generic versions of these nano-cargos.

Conclusion: Here, in this review, we have summarized the silent features of the regulatory perspectives related to nanotechnology based next generation therapeutics and diagnostics.

Keywords: Nanomedicine, nanosimilars, nanotheranostics, regulatory, pharmaceuticals, nanodevices, drug delivery.

[1]
Siafaka PI, Okur NÜ, Karantas ID, Okur ME, Gündoğdu EA. Current update on nanoplatforms as therapeutic and diagnostic tools: A review for the materials used as nanotheranostics and imaging modalities. Asian J Pharma Sci 2021; 16(1): 24-46.
[http://dx.doi.org/10.1016/j.ajps.2020.03.003] [PMID: 33613728]
[2]
Mura S, Couvreur P. Nanotheranostics for personalized medicine. Adv Drug Deliv Rev 2012; 64(13): 1394-416.
[http://dx.doi.org/10.1016/j.addr.2012.06.006] [PMID: 22728642]
[3]
Paliwal SR, Kenwat R, Maiti S, Paliwal R. Nanotheranostics for Cancer Therapy and Detection: State of the Art. Curr Pharm Des 2020; 26(42): 5503-17.
[http://dx.doi.org/10.2174/1381612826666201116120422] [PMID: 33200696]
[4]
Bawarski WE, Chidlowsky E, Bharali DJ, Mousa SA. Emerging nanopharmaceuticals. Nanomedicine 2008; 4(4): 273-82.
[http://dx.doi.org/10.1016/j.nano.2008.06.002] [PMID: 18640076]
[5]
Kurmi BD, Tekchandani P, Paliwal R, Paliwal SR. Nanocarriers in improved heparin delivery: recent updates. Curr Pharm Des 2015; 21(30): 4509-18.
[http://dx.doi.org/10.2174/1381612821666150821112808] [PMID: 26295952]
[6]
Wadhwa S, Paliwal R, Paliwal SR, Vyas SP. Nanocarriers in ocular drug delivery: an update review. Curr Pharm Des 2009; 15(23): 2724-50.
[http://dx.doi.org/10.2174/138161209788923886] [PMID: 19689343]
[7]
Vyas SP, Rai S, Paliwal R, et al. Solid lipid nanoparticles (SLNs) as a rising tool in drug delivery science: one step up in nanotechnology. Curr Nanosci 2008; 4(1): 30-44.
[http://dx.doi.org/10.2174/157341308783591816]
[8]
Weissig V, Pettinger TK, Murdock N. Nanopharmaceuticals (part 1): products on the market. Int J Nanomedicine 2014; 9(1): 4357-73.
[http://dx.doi.org/10.2147/IJN.S46900] [PMID: 25258527]
[9]
Weissig V, Guzman-Villanueva D. Nanopharmaceuticals (part 2): products in the pipeline. Int J Nanomedicine 2015; 10(1): 1245-57.
[http://dx.doi.org/10.2147/IJN.S65526] [PMID: 25709446]
[10]
Kesharwani D, Mishra S, Paul SD, Paliwal R, Satapathy T. The Functional Nanogel: An Exalted Carrier System. J Drug Deliv Ther 2019; 9(2-s): 570-82.
[11]
Paliwal R, Paliwal SR, Sulakhiya K, Kurmi BD, Kenwat R, Mamgain A. Chitosan-based nanocarriers for ophthalmic applications. In: Polysaccharide Carriers for Drug Delivery. Woodhead Publishing 2019; pp. 79-104.
[http://dx.doi.org/10.1016/B978-0-08-102553-6.00004-0]
[12]
Langer R, Peppas NA. Advances in biomaterials, drug delivery, and bionanotechnology. AIChE J 2003; 49(12): 2990-3006.
[http://dx.doi.org/10.1002/aic.690491202]
[13]
Paliwal R, Babu RJ, Palakurthi S. Nanomedicine scale-up technologies: feasibilities and challenges. AAPS PharmSciTech 2014; 15(6): 1527-34.
[http://dx.doi.org/10.1208/s12249-014-0177-9] [PMID: 25047256]
[14]
Bawa R, Melethil S, Simmons WJ, Harris D. Nanopharmaceuticals: patenting issues and FDA regulatory challenges. SciTech Lawyer 2008; 5(2): 10-5.
[15]
Souto EB, Silva GF, Dias-Ferreira J, et al. Nanopharmaceutics: Part II—Production scales and clinically compliant production methods. Nanomaterials (Basel) 2020; 10(3): 455.
[http://dx.doi.org/10.3390/nano10030455] [PMID: 32143286]
[16]
Paliwal R, Paliwal SR, Kenwat R, Kurmi BD, Sahu MK. Solid lipid nanoparticles: a review on recent perspectives and patents. Expert Opin Ther Pat 2020; 30(3): 179-94.
[http://dx.doi.org/10.1080/13543776.2020.1720649] [PMID: 32003260]
[17]
Ji X, Lu W, Wu K, Cho WC. Influencing factors of the pharmacokinetic characters on nanopharmaceutics. Pharm Nanotechnol 2017; 5(1): 24-31.
[http://dx.doi.org/10.2174/2211738505666161214142755] [PMID: 28948908]
[18]
Paliwal R, Paliwal SR, Kenwat R. Nanomedicine-based multidrug resistance reversal strategies in cancer therapy. In: Nano Drug Delivery Strategies for the Treatment of Cancers. Academic Press 2021; pp. 319-39.
[http://dx.doi.org/10.1016/B978-0-12-819793-6.00013-8]
[19]
Bragazzi NL. Nanomedicine: Insights from a bibliometrics-based analysis of emerging publishing and research trends. Medicina (Kaunas) 2019; 55(12): 785.
[http://dx.doi.org/10.3390/medicina55120785] [PMID: 31847454]
[20]
Ravindran S, Suthar JK, Rokade R, et al. Pharmacokinetics, metabolism, distribution and permeability of nanomedicine. Curr Drug Metab 2018; 19(4): 327-34.
[http://dx.doi.org/10.2174/1389200219666180305154119] [PMID: 29512450]
[21]
Ravindran S, Tambe AJ, Suthar JK, Chahar DS, Fernandes JM, Desai V. Nanomedicine: Bioavailability, biotransformation and biokinetics. Curr Drug Metab 2019; 20(7): 542-55.
[http://dx.doi.org/10.2174/1389200220666190614150708] [PMID: 31203796]
[22]
Ho D, Wang P, Kee T. Artificial intelligence in nanomedicine. Nanoscale Horiz 2019; 4(2): 365-77.
[http://dx.doi.org/10.1039/C8NH00233A] [PMID: 32254089]
[23]
Ehmann F, Sakai-Kato K, Duncan R, et al. Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines. Nanomedicine (Lond) 2013; 8(5): 849-56.
[http://dx.doi.org/10.2217/nnm.13.68] [PMID: 23656268]
[24]
Demetzos C, Kavatzikidou P, Pippa N, Stratakis E. Nanomedicines and nanosimilars: looking for a new and dynamic regulatory “astrolabe” inspired system. AAPS PharmSciTech 2020; 21(2): 65.
[http://dx.doi.org/10.1208/s12249-019-1573-y] [PMID: 31933006]
[25]
Hertig JB, Shah VP, Flühmann B, et al. Tackling the challenges of nanomedicines: are we ready? Am J Health Syst Pharm 2021; 78(12): 1047-56.
[http://dx.doi.org/10.1093/ajhp/zxab048] [PMID: 33599767]
[26]
Mühlebach S. Regulatory challenges of nanomedicines and their follow-on versions: A generic or similar approach? Adv Drug Deliv Rev 2018; 131: 122-31.
[http://dx.doi.org/10.1016/j.addr.2018.06.024] [PMID: 29966685]
[27]
Chountoulesi M, Naziris N, Pippa N, Demetzos C. The significance of drug-to-lipid ratio to the development of optimized liposomal formulation. J Liposome Res 2018; 28(3): 249-58.
[http://dx.doi.org/10.1080/08982104.2017.1343836] [PMID: 28627268]
[28]
Hu Y, Fine DH, Tasciotti E, Bouamrani A, Ferrari M. Nanodevices in diagnostics. Wiley Interdiscip Rev Nanomed Nanobiotechnol 2011; 3(1): 11-32.
[http://dx.doi.org/10.1002/wnan.82] [PMID: 20229595]
[29]
Kurmi BD, Patel P, Paliwal R, Paliwal SR. Molecular approaches for targeted drug delivery towards cancer: A concise review with respect to nanotechnology. J Drug Deliv Sci Technol 2020; 57: 101682.
[http://dx.doi.org/10.1016/j.jddst.2020.101682]
[30]
Kurmi BD, Paliwal R, Paliwal SR. Dual cancer targeting using estrogen functionalized chitosan nanoparticles loaded with doxorubicin-estrone conjugate: A quality by design approach. Int J Biol Macromol 2020; 164: 2881-94.
[http://dx.doi.org/10.1016/j.ijbiomac.2020.08.172] [PMID: 32853621]
[31]
Paliwal R, Paliwal SR, Vyas SP. Editorial: nanotherapeutics for cancer imaging and therapy. Mini Rev Med Chem 2017; 17(18): 1686-7.
[http://dx.doi.org/10.2174/138955751718171107142220] [PMID: 29182896]
[32]
Rosen JE, Yoffe S, Meerasa A, Verma M, Gu FX. Nanotechnology and diagnostic imaging: new advances in contrast agent technology. J Nanomed Nanotechnol 2011; 2(5): 1-2.
[http://dx.doi.org/10.4172/2157-7439.1000115]
[33]
Paliwal SR, Paliwal R, Agrawal GP, Vyas SP. Liposomal nanomedicine for breast cancer therapy. Nanomedicine (Lond) 2011; 6(6): 1085-100.
[http://dx.doi.org/10.2217/nnm.11.72] [PMID: 21955078]
[34]
Ain QU. Current and future aspects of smart nanotheranostic agents in cancer therapeutics. In: Nanotheranostics. Cham: Springer 2019; pp. 213-27.
[35]
Etheridge ML, Campbell SA, Erdman AG, Haynes CL, Wolf SM, McCullough J. The big picture on nanomedicine: the state of investigational and approved nanomedicine products. Nanomedicine 2013; 9(1): 1-14.
[http://dx.doi.org/10.1016/j.nano.2012.05.013] [PMID: 22684017]
[36]
Davenport M. Closing the gap for generic nanomedicines. Chem Eng News 2014; 92(45): 10-3.
[37]
Halamoda-Kenzaoui B, Holzwarth U, Roebben G, Bogni A, Bremer-Hoffmann S. Mapping of the available standards against the regulatory needs for nanomedicines. Wiley Interdiscip Rev Nanomed Nanobiotechnol 2019; 11(1): e1531.
[http://dx.doi.org/10.1002/wnan.1531] [PMID: 29923692]
[38]
de Vlieger JS, Crommelin DJ, Tyner K, et al. Report of the AAPS guidance forum on the FDA draft guidance for industry: Drug products, including biological products, that contain nanomaterials AAPS J 2019; 21(4): 56.
[39]
De la Ossa DP. Quality aspects of Nano-based medicines. Proceedings of the SME workshop: focus on quality for medicines containing chemical entities. London, UK. 2014.Vol. 4
[40]
Working PK, Dayan AD. Pharmacological-toxicological expert report. CAELYX. (Stealth liposomal doxorubicin HCl). Hum Exp Toxicol 1996; 15(9): 751-85.
[PMID: 8880211]
[41]
Bulbake U, Doppalapudi S, Kommineni N, Khan W. Liposomal formulations in clinical use: an updated review. Pharmaceutics 2017; 9(2): 12.
[http://dx.doi.org/10.3390/pharmaceutics9020012] [PMID: 28346375]
[42]
Rodriguez MA, Pytlik R, Kozak T, et al. Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study. Cancer 2009; 115(15): 3475-82.
[http://dx.doi.org/10.1002/cncr.24359] [PMID: 19536896]
[43]
Mayer LD, Tardi P, Louie AC. CPX-351: a nanoscale liposomal co-formulation of daunorubicin and cytarabine with unique biodistribution and tumor cell uptake properties. Int J Nanomedicine 2019; 14: 3819-30.
[http://dx.doi.org/10.2147/IJN.S139450] [PMID: 31213803]
[44]
Downing NS, Ross JS, Jackevicius CA, Krumholz HM. Avoidance of generic competition by Abbott Laboratories’ fenofibrate franchise. Arch Intern Med 2012; 172(9): 724-30.
[http://dx.doi.org/10.1001/archinternmed.2012.187] [PMID: 22493409]
[45]
Ling H, Luoma JT, Hilleman D. A review of currently available fenofibrate and fenofibric acid formulations. Cardiol Res 2013; 4(2): 47-55.
[http://dx.doi.org/10.4021/cr270w] [PMID: 28352420]
[46]
Hu B, Zhong L, Weng Y, et al. Therapeutic siRNA: state of the art. Signal Transduct Target Ther 2020; 5(1): 101.
[http://dx.doi.org/10.1038/s41392-020-0207-x] [PMID: 32561705]
[47]
Understanding the nanotechnology in COVID-19 vaccines. Available from: https://www.cas.org/blog/understanding-nanotechnology-covid-19-vaccines
[48]
Farjadian F, Ghasemi A, Gohari O, Roointan A, Karimi M, Hamblin MR. Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities. Nanomedicine (Lond) 2019; 14(1): 93-126.
[http://dx.doi.org/10.2217/nnm-2018-0120] [PMID: 30451076]
[49]
Kalepu S, Nekkanti V. Insoluble drug delivery strategies: review of recent advances and business prospects. Acta Pharm Sin B 2015; 5(5): 442-53.
[http://dx.doi.org/10.1016/j.apsb.2015.07.003] [PMID: 26579474]
[50]
Vikas, Viswanadh MK, Priya V, Mehata AK, Muthu MS.. What are the unexplored facts about nanomicelles formed from docetaxel clinical injection?. 2006.
[51]
Anhalt K. Oral nanocrystal formulations and their biopharmaceutical characterization (Doctoral dissertation), University of Heidelberg, 2021.
[52]
Hafner A, Lovrić J, Lakoš GP, Pepić I. Nanotherapeutics in the EU: an overview on current state and future directions. Int J Nanomedicine 2014; 9: 1005-23.
[PMID: 24600222]
[53]
Wagner V, Dullaart A, Bock AK, Zweck A. The emerging nanomedicine landscape. Nat Biotechnol 2006; 24(10): 1211-7.
[http://dx.doi.org/10.1038/nbt1006-1211] [PMID: 17033654]
[54]
Wang YX. Current status of superparamagnetic iron oxide contrast agents for liver magnetic resonance imaging. World J Gastroenterol 2015; 21(47): 13400-2.
[http://dx.doi.org/10.3748/wjg.v21.i47.13400] [PMID: 26715826]
[55]
Evans JA, Wallis SC, Dulhunty JM, Pang G. Binding of local anaesthetics to the lipid emulsion Clinoleic™ 20%. Anaesth Intensive Care 2013; 41(5): 618-22.
[http://dx.doi.org/10.1177/0310057X1304100507] [PMID: 23977913]
[56]
Soares S, Sousa J, Pais A, Vitorino C. Nanomedicine: principles, properties, and regulatory issues. Front Chem 2018; 6: 360.
[http://dx.doi.org/10.3389/fchem.2018.00360] [PMID: 30177965]
[57]
Lallemand F, Schmitt M, Bourges JL, Gurny R, Benita S, Garrigue JS. Cyclosporine A delivery to the eye: A comprehensive review of academic and industrial efforts. Eur J Pharm Biopharm 2017; 117: 14-28.
[http://dx.doi.org/10.1016/j.ejpb.2017.03.006] [PMID: 28315447]
[58]
Faschinger AM, Sessler N. Development of a lyophilized formulation of pegaspargase and comparability versus liquid pegaspargase. Adv Ther 2019; 36(8): 2106-21.
[http://dx.doi.org/10.1007/s12325-019-00988-5] [PMID: 31140125]
[59]
Zhao P, Zhang Y, Li W, Jeanty C, Xiang G, Dong Y. Recent advances of antibody drug conjugates for clinical applications. Acta Pharm Sin B 2020; 10(9): 1589-600.
[http://dx.doi.org/10.1016/j.apsb.2020.04.012] [PMID: 33088681]
[60]
EnGeneIC receives FDA orphan drug designation for targeted EDV™ nanocells to treat glioblastoma multiforme. 2017. Available from: https://www.prnewswire.com/news-releases/engeneic-receives-fda-orphan-drug-designation-for-targeted-edv-nanocells- to-treat-glioblastoma-multiforme-300416578.html
[61]
Miele E, Spinelli GP, Miele E, Tomao F, Tomao S. Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer. Int J Nanomedicine 2009; 4: 99-105.
[PMID: 19516888]
[62]
ONTAK Generic Name: denileukin diftitox. Available from: https://www.rxlist.com/ontak-drug.htm#description
[63]
Bailey K, Mountian I, Bruggraber R, Sunderland K, Tilt N, Szegvari B. Patient Satisfaction with CIMZIA® (Certolizumab Pegol) AutoClicks® in the UK. Adv Ther 2020; 37(4): 1522-35.
[http://dx.doi.org/10.1007/s12325-020-01257-6] [PMID: 32124272]
[64]
Dehnes Y, Hemmersbach P. Effect of single doses of methoxypolyethylene glycol-epoetin beta (CERA, Mircera™) and epoetin delta (Dynepo™) on isoelectric erythropoietin profiles and haematological parameters. Drug Test Anal 2011; 3(5): 291-9.
[http://dx.doi.org/10.1002/dta.270] [PMID: 21387570]
[65]
KRYSTEXXA works differently than oral gout medicines to quickly dissolve gout buildup. Horizon Therapeutics plc Available from: https://www.krystexxa.com/gout-treatment.
[66]
Rai MF, Pham CT. Intra-articular drug delivery systems for joint diseases. Curr Opin Pharmacol 2018; 40: 67-73.
[http://dx.doi.org/10.1016/j.coph.2018.03.013] [PMID: 29625332]
[67]
EMA. 2000. "Summary of product characteristics- Renagel". Available from: https://www.medicines.org.uk/emc/product/207/smpc#gref.
[68]
Puvvada SD, Guillén-Rodríguez JM, Yan J, et al. Yttrium-90-Ibritumomab tiuxetan (Zevalin®) radioimmunotherapy after cytoreduction with ESHAP chemotherapy in patients with relapsed follicular non-Hodgkin lymphoma: final results of a phase II study. Oncology 2018; 94(5): 274-80.
[http://dx.doi.org/10.1159/000486788] [PMID: 29471300]
[69]
Hasson T, Kolitz S, Towfic F, et al. Functional effects of the antigen glatiramer acetate are complex and tightly associated with its composition. J Neuroimmunol 2016; 290: 84-95.
[http://dx.doi.org/10.1016/j.jneuroim.2015.11.020] [PMID: 26711576]
[70]
Burade V, Bhowmick S, Maiti K, Zalawadia R, Ruan H, Thennati R. Lipodox® (generic doxorubicin hydrochloride liposome injection): In vivo efficacy and bioequivalence versus Caelyx® (doxorubicin hydrochloride liposome injection) in human mammary carcinoma (MX-1) xenograft and syngeneic fibrosarcoma (WEHI 164) mouse models. BMC Cancer 2017; 17(1): 405.
[http://dx.doi.org/10.1186/s12885-017-3377-3] [PMID: 28587612]
[71]
Liu Z, Chen X. Simple bioconjugate chemistry serves great clinical advances: albumin as a versatile platform for diagnosis and precision therapy. Chem Soc Rev 2016; 45(5): 1432-56.
[http://dx.doi.org/10.1039/C5CS00158G] [PMID: 26771036]
[72]
Fromer MJ. ODAC decides all thumbs way down for abraxane because sponsor requests to omit randomized trial. Oncology Times 2006; 28(18): 24.
[http://dx.doi.org/10.1097/01.COT.0000303889.15497.94]
[73]
Nanoparticle technology now allows TriCor(R) to be taken with or without food. Illinois: Abbott Laboratories. 2006.
[74]
Chen ML, John M, Lee SL, Tyner KM. Development considerations for nanocrystal drug products. AAPS J 2017; 19(3): 642-51.
[http://dx.doi.org/10.1208/s12248-017-0064-x] [PMID: 28281194]
[75]
Colmar Eric. Summary reveiw for regulatory action. 2008. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203923Orig1s000SumR.pdf.
[76]
Muthu MS, Kulkarni SA, Liu Y, Feng SS. Development of docetaxel-loaded vitamin E TPGS micelles: formulation optimization, effects on brain cancer cells and biodistribution in rats. Nanomedicine (Lond) 2012; 7(3): 353-64.
[http://dx.doi.org/10.2217/nnm.11.111] [PMID: 22329606]
[77]
Generic Taxotere availability. Available from: https://www.drugs.com/availability/generic-taxotere.html
[78]
Bashir MR, Bhatti L, Marin D, Nelson RC. Emerging applications for ferumoxytol as a contrast agent in MRI. J Magn Reson Imaging 2015; 41(4): 884-98.
[http://dx.doi.org/10.1002/jmri.24691] [PMID: 24974785]
[79]
Wáng YX, Idée JM. A comprehensive literatures update of clinical researches of superparamagnetic resonance iron oxide nanoparticles for magnetic resonance imaging. Quant Imaging Med Surg 2017; 7(1): 88-122.
[http://dx.doi.org/10.21037/qims.2017.02.09] [PMID: 28275562]
[80]
Editorial. Let’s talk about lipid nanoparticles. Nat Rev Mater 2021; 6: 99.
[http://dx.doi.org/10.1038/s41578-021-00281-4]
[81]
Onpattro. European Medicine Agency. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/onpattro
[82]
Zhu X, Li H, Huang L, Zhang M, Fan W, Cui L. 3D printing promotes the development of drugs. Biomed Pharmacother 2020; 131: 110644.
[http://dx.doi.org/10.1016/j.biopha.2020.110644] [PMID: 32853908]
[83]
rebuffs Monsanto S. First 3D-printed pill. Nature Biotech 2015; 33(10): 1014.
[85]
Guidance document: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. Accessed on March 11, 2021 Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm
[86]
Guidance document: liposome drug products-chemistry, manufacturing, and controls; human pharmacokinetics and bioavailability; and labeling documentation-guidance for industry. Accessed on March 11, 2021 Available from: https://www.fda.gov/media/70837/download
[87]
COMMISSION RECOMMENDATION of 18 October 2011on the definition of nanomaterial; Official Journal of the European Union. 2011. Accessed on March 11, 2021 Available from: https://ec.europa.eu/research/industrial_technologies/pdf/policy/commission-recommendation-on-the-definition-of-nanomater-18102011_en.pdf
[88]
Pita R, Ehmann F, Papaluca M. Nanomedicines in the EU—regulatory overview. AAPS J 2016; 18(6): 1576-82.
[http://dx.doi.org/10.1208/s12248-016-9967-1] [PMID: 27527889]
[89]
Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product. Accessed on March 11, 2021 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-iron-based-nano-colloidal-products-developed_en.pdf
[90]
Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product. Accessed on March 11, 2021 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-liposomal-products-developed-reference-innovator_en.pdf
[91]
Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products. Accessed on March 11, 2021 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/joint-mhlw/ema-reflection-paper-development-block-copolymer-micelle-medicinal-products_en.pdf
[92]
Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products. Accessed on March 11, 2021 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-surface-coatings-general-issues-consideration-regarding-parenteral-administration_en.pdf
[93]
Foulkes R, Man E, Thind J, Yeung S, Joy A, Hoskins C. The regulation of nanomaterials and nanomedicines for clinical application: current and future perspectives. Biomater Sci 2020; 8(17): 4653-64.
[http://dx.doi.org/10.1039/D0BM00558D] [PMID: 32672255]
[94]
Guidelines For Evaluation Of Nanopharmaceuticals In India. Government of India New Delhi October 2019. 2019. Accessed on March 11, 2021 Available from: http://dbtindia.gov.in/sites/default/files/uploadfiles/Guidelines_For_Evaluation_of_Nanopharmaceuticals_in_India_24.10.19.pdf

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