REFERENCES
1. Du S, Guan Y, Xie A, et al. Extracellular vesicles: a rising star for therapeutics and drug delivery. J Nanobiotechnology. 2023;21:231.
2. Kumar MA, Baba SK, Sadida HQ, et al. Extracellular vesicles as tools and targets in therapy for diseases. Signal Transduct Target Ther. 2024;9:27.
3. Jay SM. Addressing barriers to clinical translation of extracellular vesicle therapeutics. Mol Ther. 2025;33:1879-80.
4. Mizenko RR, Feaver M, Bozkurt BT, et al. A critical systematic review of extracellular vesicle clinical trials. J Extracell Vesicles. 2024;13:e12510.
5. Moghassemi S, Dadashzadeh A, Sousa MJ, et al. Extracellular vesicles in nanomedicine and regenerative medicine: a review over the last decade. Bioact Mater. 2024;36:126-56.
6. Giebel B. A milestone for the therapeutic EV field: FDA approves Ryoncil, an allogeneic bone marrow-derived mesenchymal stromal cell therapy. Extracell Vesicles Circ Nucl Acids. 2025;6:183-90.
7. Fujita M, Hatta T, Ikka T, Onishi T. The urgent need for clear and concise regulations on exosome-based interventions. Stem Cell Reports. 2024;19:1517-9.
8. Therapeutic Goods Administration (TGA). Australian Register of Therapeutic Goods (ARTG). Available from: https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg. [Last accessed on 27 Feb 2026].
9. House of Representatives Standing Committee on Health, Aged Care and Sport Report. The New Frontier - Delivering better health for all Australians: inquiry into approval processes for new drugs and novel medical technologies in Australia. Available from: https://www.aph.gov.au/Parliamentary_Business/Committees/House/Former_Committees/Health_Aged_Care_and_Sport/Newdrugs/Report. [Last accessed on 25 Feb 2026].
10. Department of Health and Aged Care. Health technology assessments. Available from: https://www.health.gov.au/topics/health-technologies-and-digital-health/health-technology-assessments. [Last accessed on 25 Feb 2026].
11. TGA Online Database. Australian Register of Therapeutic Goods (ARTG). Available from: https://www.tga.gov.au/resources/artg. [Last accessed on 25 Feb 2026].
12. Ghodasara A, Raza A, Wolfram J, Salomon C, Popat A. Clinical Translation of Extracellular Vesicles. Adv Healthc Mater. 2023;12:e2301010.
13. Therapeutic Goods Act 1989 (Cth) Part 3-2A Division 4. Available from: https://www.legislation.gov.au/C2004A03952/latest. [Last accessed on 25 Feb 2026].
14. Mesoblast Limited ASX Announcement. Mesoblast receives complete response from U.S. Food and Drug Administration for biologics license application for steroid-refractory acute graft versus host disease in children. Available from: https://investorsmedia.mesoblast.com/static-files/422cd6da-a0b9-49cf-a177-7fd106f111f2. [Last accessed on 25 Feb 2026].
15. Welsh JA, Goberdhan DCI, O’Driscoll L, et al; MISEV Consortium. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. J Extracell Vesicles. 2024;13:e12404.
16. Therapeutic Goods Act 1989 (Cth) section 32AA. Available from: https://www.legislation.gov.au/C2004A03952/latest. [Last accessed on 25 Feb 2026].
17. TGA. Classification of biologicals: Australian Regulatory Guidelines for Biologicals (ARGB). Available from: https://www.tga.gov.au/sites/default/files/classification-biologicals.pdf. [Last accessed on 25 Feb 2026].
18. Phan TH, Kim SY, Rudge C, Chrzanowski W. Made by cells for cells - extracellular vesicles as next-generation mainstream medicines. J Cell Sci. 2022;135:jcs259166.
19. Therapeutic Goods (Biologicals-Information that Must Accompany Application for Inclusion in Register) Determination July 2018 (Cth). Available from: https://www.legislation.gov.au/F2018L01078/latest. [Last accessed on 25 Feb 2026].
20. TGA. Dossier requirements for Class 2, 3 and 4 biologicals. Australian Regulatory Guidelines for Biologicals (ARGB). Available from: https://www.tga.gov.au/resources/guidance/dossier-requirements-class-2-3-and-4-biologicals. [Last accessed on 25 Feb 2026].
21. TGA. Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods. Available from: https://www.tga.gov.au/resources/guidance/special-access-scheme-sas-guidance-health-practitioners-accessing-unapproved-therapeutic-goods. [Last accessed on 25 Feb 2026].
22. Therapeutic Goods Regulations 1990 (Cth) r 12A(5). Available from: https://www.legislation.gov.au/F1996B00406/latest. [Last accessed on 25 Feb 2026].
23. Therapeutic Goods Regulations 1990 (Cth) r 12A(2)-(3). Available from: https://www.legislation.gov.au/F1996B00406/latest. [Last accessed on 25 Feb 2026].
24. TGA Online Database. Special Access Scheme (SAS) Category C lists. Available from: https://www.tga.gov.au/products/unapproved-therapeutic-goods/prescribe-unapproved-therapeutic-good-health-practitioners/lists-products-established-history-use/special-access-scheme-sas-category-c-lists#biologicals. [Last accessed on 25 Feb 2026].
25. TGA. Access unapproved products (consumers). Available from: https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-unapproved-products-consumers. [Last accessed on 25 Feb 2026].
26. TGA. Authorised Prescriber Scheme: Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors. Available from: https://www.tga.gov.au/sites/default/files/2024-03/authorised-prescriber-scheme-guidance.docx. [Last accessed on 25 Feb 2026].
27. McClelland R, Rudge C. The medicalisation of psychedelic drugs in Australia: regulatory implications of a novel treatment. Melb Univ Law Rev. 2025;48:733. Available from: https://law.unimelb.edu.au/__data/assets/pdf_file/0005/5478719/McClelland-and-Rudge-MULR-483-733.pdf. [Last accessed on 27 Feb 2026].
28. Therapeutic Goods Act 1989 (Cth) section 7AA. Available from: https://www.legislation.gov.au/C2004A03952/latest. [Last accessed on 25 Feb 2026].
29. Therapeutic Goods Act 1989 (Cth) section 18. Available from: https://www.legislation.gov.au/C2004A03952/latest. [Last accessed on 25 Feb 2026].
30. Therapeutic Goods (Excluded Goods) Determination 2018 (Cth) section 6. Available from: https://www.legislation.gov.au/F2018L01350/latest. [Last accessed on 25 Feb 2026].
31. TGA. Determining if a biological product is for homologous use. Available from: https://www.tga.gov.au/resources/guidance/determining-if-biological-product-homologous-use. [Last accessed on 25 Feb 2026].
32. TGA. Understanding the minimal manipulation method of preparation for biologicals. Available from: https://www.tga.gov.au/resources/guidance/understanding-minimal-manipulation-method-preparation-biologicals. [Last accessed on 25 Feb 2026].
33. Liu YJ, Wang C. A review of the regulatory mechanisms of extracellular vesicles-mediated intercellular communication. Cell Commun Signal. 2023;21:77.
34. Bahmani L, Ullah M. Different sourced extracellular vesicles and their potential applications in clinical treatments. Cells. 2022;11:1989.
35. Kim HI, Park J, Zhu Y, Wang X, Han Y, Zhang D. Recent advances in extracellular vesicles for therapeutic cargo delivery. Exp Mol Med. 2024;56:836-49.
36. Tam S, Wear D, Morrone CD, Yu WH. The complexity of extracellular vesicles: Bridging the gap between cellular communication and neuropathology. J Neurochem. 2024;168:2391-422.
37. Verma N, Arora S. Navigating the global regulatory landscape for exosome-based therapeutics: challenges, strategies, and future directions. Pharmaceutics. 2025;17:990.
38. Greening DW, Xu R, Rai A, Suwakulsiri W, Chen M, Simpson RJ. Clinical relevance of extracellular vesicles in cancer - therapeutic and diagnostic potential. Nat Rev Clin Oncol. 2025;22:924-52.
39. Rudge C, Attinger S, Kerridge I, Lipworth W, Stewart C. A new priority pathway for biologicals in Australia: contextualising and evaluating the proposed reforms. J Law Med. 2022;29:677-99.
40. Van Delen M, Derdelinckx J, Wouters K, Nelissen I, Cools N. A systematic review and meta-analysis of clinical trials assessing safety and efficacy of human extracellular vesicle-based therapy. J Extracell Vesicles. 2024;13:e12458.
41. Australian Government. Australian Government response to the Standing Committee on Health, Aged Care and Sport report: The New Frontier - Delivering better health for all Australians. Available from: https://www.health.gov.au/sites/default/files/2023-11/inquiry-into-approval-processes-for-new-drugs-and-novel-medical-technologies-in-australia.pdf. [Last accessed on 25 Feb 2026].
42. Health Technology Assessment Policy and Methods Review. Accelerating access to the best medicines for Australians now and into the future. Available from: https://www.health.gov.au/sites/default/files/2024-09/health-technology-assessment-policy-and-methods-review-final-report_0.pdf. [Last accessed on 25 Feb 2026].
43. Health Technology Assessment Policy and Methods Review. Emerging health technologies. Available from: https://health.gov.au/sites/default/files/2024-07/hta-policy-and-methods-review-emerging-health-technologies.pdf. [Last accessed on 25 Feb 2026].







