Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics
| Autor: | Megan Munsie, Cameron Stewart, Christopher Rudge, Narcyz Ghinea |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Embryology
Quality Assurance Health Care 0206 medical engineering Biomedical Engineering Cell- and Tissue-Based Therapy 02 engineering and technology 03 medical and health sciences Government regulation Advertising Health care Humans Marketing 030304 developmental biology Marketing of Health Services 0303 health sciences business.industry Stem Cells Australia Human cell 020601 biomedical engineering New product development Practice Guidelines as Topic Government Regulation Stem cell business Administration (government) Stem Cell Transplantation |
| Zdroj: | Regenerative medicine. 15(2) |
| ISSN: | 1746-076X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|