Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan
| Autor: | Masayuki Yamato, Kenichiro Tsuyuki, Natsumi Watanabe, Taisuke Ikawa, Hiroshi Kasanuki, Kazuo Yano |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Macrophage Biomedical Engineering Autologous cell Biomaterials Regulatory science medicine media_common.cataloged_instance Tissue engineering European union lcsh:QH573-671 media_common New drug application Control treatment lcsh:R5-920 business.industry lcsh:Cytology Humanitarian Device Exemption Biological product Chondrocyte Biotechnology Clinical trial Epithelial cell Family medicine Regenerative medicine Biologics License Application Fibroblast Original Article business lcsh:Medicine (General) Developmental Biology |
| Zdroj: | Regenerative Therapy, Vol 1, Iss C, Pp 45-56 (2015) Regenerative Therapy |
| ISSN: | 2352-3204 |
| Popis: | Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the definition, legislation, and approval system of these products were surveyed. A total of nine autologous human cells and tissue products approved until October 2013 were collected. The definitions of human cells and tissue products were compatible among the US, the EU and Japan. The products were classified as human cells, tissue, and cellular and tissue-based products (HCT/Ps) in the US, advanced therapy medicinal products (ATMPs) in the EU, and cell/tissue-engineered products in Japan. These products were categorized as biologics and medical device in the US and Japan, and drug in the EU. The issuance of new guidance induced regulatory impact for manufacturer, especially in the US. These products are subjected to the accelerated approval of biological product, the humanitarian device exemption approval, the premarket application approval, the biologics license application approval, and new drug application approval with specific targeting of postapproval registry or surveillance. Of nine autologous human cells and tissue products, four products had been evaluated using clinical experiences or open clinical trials with small subjects, although the rests of products had been evaluated using comparative clinical trials with control treatment. Our survey suggests that autologous human cells and tissue products would need postmarket-oriented evaluation rather than premarket-oriented evaluation for doctors and patients. |
| Databáze: | OpenAIRE |
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