Volume 5 Number 1 2026
Regulatory Pathways for Nanotheranostics and Nanobiosensors: A Comparative Review of FDA, EMA and Emerging-Market Frameworks
Saba Zafar 1*, Pugazhandhi Bakthavatchalam 2
Biosensors and Nanotheranostics 5 (1) 1-8 https://doi.org/10.25163/biosensors.5111003
Submitted: 23 August 2026 Revised: 12 October 2026 Accepted: 22 October 2026 Published: 24 October 2026
Nanotheranostics, which fuse imaging and therapy within a single nanoscale vehicle, and nanobiosensors, which detect disease biomarkers at femtomolar-to-attomolar concentrations, sit close to the heart of precision medicine. Yet after more than two decades of preclinical promise, only a handful of these products have reached patients. This review asks why, and argues that much of the answer lies in regulation rather than in the laboratory. We compared how the United States Food and Drug Administration (FDA), the European Medicines Agency and European Commission, and regulators in emerging markets (India, China, South Korea and Brazil) classify, evaluate and authorize nanotechnology-enabled health products. Drawing on peer-reviewed literature, regulatory guidance and international standards, we synthesized evidence on premarket pathways, combination-product jurisdiction, critical quality attributes, nanotoxicology and diagnostic validation. Three patterns emerged. First, the FDA works within existing drug and device statutes and assigns multifunctional products by primary mode of action, whereas the European Union applies explicit nano-specific rules, most notably Rule 19 of the Medical Devices Regulation and the stricter In Vitro Diagnostic Regulation. Second, products acting through physical mechanisms, such as NanoTherm® and NBTXR3/Hensify®, have reached the market more easily than systemically delivered, multi-component theranostics, and highly sensitive biosensors often lag behind simpler, more reproducible electrochemical designs. Third, emerging markets still lean on legacy frameworks and foreign precedent, while high characterization and manufacturing costs widen global inequity. We conclude that convergent, risk-proportionate regulation, built on shared standards, validated nano-specific assays and mutual recognition, could narrow the translational gap without weakening patient safety.
Keywords: nanotheranostics; nanobiosensors; regulatory science; combination products; EU MDR Rule 19; IVDR; critical quality attributes; nanotoxicology; companion diagnostics; emerging markets
Aarabi, M., & Faraji Azad, H. (2026). Review of advanced nanosensors in nanomedicine: Bridging biosensing innovations with therapeutic applications. IET Science, Measurement & Technology, 20(3), 112–135.
Ahmad, A., Imran, M., & Sharma, N. (2022). Precision nanotoxicology in drug development: Current trends and challenges in safety and toxicity implications of customized multifunctional nanocarriers for drug-delivery applications. Pharmaceutics, 14(11), 2463.
Breast Cancer Book. (2025). Translational nanotechnology in oncology: Bench-to-bedside paradigm shifts. Academic Press.
Calatayud, D. G., Neophytou, S., Nicodemou, E., Giuffrida, S. G., Ge, H., & Pascu, S. I. (2022). Nano-theranostics for the sensing, imaging and therapy of prostate cancer. Frontiers in Chemistry, 10, 830133.
Chávez-Hernández, J. A., Velarde-Salcedo, A. J., Navarro-Tovar, G., & Gonzalez, C. (2024). Safe nanomaterials: From their use, application, and disposal to regulations. Nanoscale Advances, 6(6), 1583–1610.
Chen, L., & Li, Q. (2025). Nanosystems for drug delivery to gastrointestinal tumors: Advances and clinical translation. Materials Today Bio, 32, 101782.
Csóka, I., Ismail, R., Jójárt-Laczkovich, O., & Pallagi, E. (2021). Regulatory considerations, challenges and risk-based approach in nanomedicine development. Current Medicinal Chemistry, 28(36), 7461–7476. https://doi.org/10.2174/0929867328666210406115529
D’Alton, L., Souto, D. E. P., Punyadeera, C., Abbey, B., Voelcker, N. H., Hogan, C., & Silva, S. M. (2024). A holistic pathway to biosensor translation. Sensors & Diagnostics, 3(8), 1234–1246.
Fadeel, B., Farcal, L., Hardy, B., Vázquez-Campos, S., Hristozov, D., Marcomini, A., Lynch, I., Valsami-Jones, E., Alenius, H., & Savolainen, K. (2018). Advanced tools for the safety assessment of nanomaterials. Nature Nanotechnology, 13(7), 537–543. https://doi.org/10.1038/s41565-018-0185-0
Funkhouser, J. (2002). Reinventing pharma: The theranostic revolution. Current Drug Discovery, 2(2), 17–19.
Gidwani, B., Sahu, V., Shah, K., Chauhan, N. S., Alomary, M. N., Ansari, M. A., & Anand, S. (2025). Nanotheranostics: Emerging nanomachines as pharmacotherapeutics. 3 Biotech, 15(11), 442. https://doi.org/10.1007/s13205-025-04589-8
Gupta, D., Kumar, S., & Sharma, R. (2026). Nanotechnology-driven cancer theranostics: Translational hurdles, regulatory landscapes, and clinical perspectives. International Journal of Nanomedicine, 21, 568254. https://doi.org/10.2147/IJN.S568254
Hirulkar, R., Chaurawal, N., Alhodieb, F. S., Barkat, H., Preet, S., & Raza, K. (2024). Nanotheranostics: Clinical status, toxicity, regulatory consideration, and future prospects. In M. A. Barkat, F. J. Ahmad, M. A. Rahman, & M. A. Ansari (Eds.), Nanotheranostics for diagnosis and therapy (pp. 215–242). Springer.
International Organization for Standardization. (2025). Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO Standard No. 10993-1:2025). https://www.iso.org/standard/10993-1
Jahnavi, E. P., et al. (2025). Nanotheranostic agents: Engineering, applications, and translational challenges. Journal of Healthcare Engineering and Diagnostics, Article 10.69613/jh2dqe17.
Kang, S. L., Woo, J. H., Kim, N. H., Kwon, J. Y., & Kim, S. M. (2023). Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS. Molecular Therapy: Methods & Clinical Development, 30, 447–458.
Kim, T. H., Lee, S., & Chen, X. (2013). Nanotheranostics for personalized medicine. Expert Review of Molecular Diagnostics, 13(3), 257–269. https://doi.org/10.1586/erm.13.15
Klein, K., Langhof, H., Ehmann, F., Tzara, A., Giuliani, A., Reischl, I. G., et al. (2024). Heterogeneity of regulatory approval pathways for nanomedicinal products in the EU—but broadly applicable to nanocarriers including those targeting the BBB. The AAPS Journal, 26(5), 102.
Musa, S. S., et al. (2025). The fusion of molecular-scale engineering in nanotechnology with machine learning analytics in precision medicine. Intelligence-Based Medicine, 12, 100267. https://doi.org/10.1016/j.ibmed.2025.100267
Pawnikar, V., & Patel, M. (2025). Biosensors in wearable medical devices: Regulatory framework and compliance across US, EU, and Indian markets. In Biosensors and bioelectronics: Healthcare applications (Vol. 83, pp. 637–648). Elsevier.
Quesada-González, D., & Merkoçi, A. (2018). Nanomaterial-based devices for point-of-care diagnostic applications. Chemical Society Reviews, 47(13), 4697–4709.
Rahman, M. Z. (2026). Sustainable polymer nanocomposites for biomedical and smart applications: Translational challenges and regulatory expectations. Materials Today Communications, 42, 116193. https://doi.org/10.1016/j.mtcomm.2026.116193
Rodríguez-Gómez, F. D., Monferrer, D., Penon, O., & Rivera-Gil, P. (2025). Regulatory pathways and guidelines for nanotechnology-enabled health products: A comparative review of EU and US frameworks. Frontiers in Medicine, 12, 1544393. https://doi.org/10.3389/fmed.2025.1544393
Roy, S., Kumar, R., Acooli, A., Roy, S., Chatterjee, A., Chattaraj, S., Nayak, J., Jeon, B. H., Basu, A., Banerjee, S., & Chakrabortty, S. (2024). Transforming nanomaterial synthesis through advanced microfluidic approaches: A review on accessing unrestricted possibilities. Journal of Composites Science, 8(10), 386.
Sharon, S., Mainkar, G., & Zangi, L. (2026). Personalized nanomedicine: Integrating molecular stratification with engineered delivery systems. Journal of Nanotheranostics, 7(2), 9–22. https://doi.org/10.3390/jnt7020009
Souto, E. B., Blanco-Llamero, C., Krambeck, K., Kiran, N. S., Yashaswini, C., Postwala, H., Severino, P., Priefer, R., Prajapati, B. G., & Maheshwari, R. (2024). Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives. Acta Biomaterialia, 180, 1–17. https://doi.org/10.1016/j.actbio.2024.04.010
Sustainable PNC Review. (2026). Sustainable polymer nanocomposites in healthcare: Clinical translation, environmental life-cycle analysis, and regulatory policy. Materials Today Bio, 34, 101890.
U.S. Food and Drug Administration. (2004). Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2024). Considerations for drug products, including biological products, that contain nanomaterials: Guidance for industry. Center for Drug Evaluation and Research.
Ulucan-Karnak, F., Kuru, C. I., & Akgöl, S. (2024). Commercial roadmap of nanobiosensor development. Frontiers in Nanotechnology, 6, 1348308.
Viegas, C., Patrício, A. B., Prata, J., Fonseca, L., Macedo, A. S., Duarte, S. O. D., et al. (2023). Advances in pancreatic cancer treatment by nano-based drug delivery systems. Pharmaceutics, 15(9), 2363.
Wang, X., et al. (2026). Nanotechnology-enabled modalities for hepatocellular carcinoma: Therapeutic advances and safety profiling. International Journal of Nanomedicine, 21, 581911. https://doi.org/10.2147/IJN.S581911
Xia, Q., Jiang, H., Liu, X., Yin, L., & Wang, X. (2024). Advances in engineered nano-biosensors for bacteria diagnosis and multidrug resistance inhibition. Biosensors, 14(2), 59. https://doi.org/10.3390/bios14020059
Yang, Z., et al. (2026). Nano-reagents in acute pancreatitis: Translational landscape and clinical challenges. International Journal of Nanomedicine, 21, 562220. https://doi.org/10.2147/IJN.S562220
Zhu, Y., et al. (2025). Multifunctional nanomaterials for cancer theranostics: Regulatory perspectives and clinical translation. International Journal of Nanomedicine, 20, 13689–13719.
Nanomaterial Interference and Blood Compatibility Gaps in ISO 10993 Testing of Biomaterial Interfaces.
Sustainable and Green Nanomaterials in Biosensing and Nanotheranostics: Life-Cycle, Toxicity, and Circular Design Perspectives
Computational Design of Protein-Based Diagnostic Assays for Early Cancer Detection: Platforms, Algorithms, and the Road to Clinical Translation