Sydney Health Ethics, Faculty of Medicine & Health, The University of Sydney, New South Wales, Australia.
Sydney Law School, University of Sydney, New South Wales, Australia.
Regen Med. 2020 Feb;15(2):1361-1369. doi: 10.2217/rme-2019-0124. Epub 2020 Mar 31.
In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.
2018 年，澳大利亚治疗商品管理局出台了监管改革措施，对源于患者自身细胞和组织的产品的监管制定了更严格的标准，这对提供干细胞治疗的诊所产生了重大影响。我们回顾了监管框架，并讨论了其潜在的商业影响，包括其在实践中可能产生的歧义，以及它对未来产品开发和广告实践可能产生的影响。
