doi: 10.3233/BME-2010-0623.
Regulatory enablers and regulatory challenges for the development of tissue-engineered products in the EU
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- PMID: 20930319
- DOI: 10.3233/BME-2010-0623
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Regulatory enablers and regulatory challenges for the development of tissue-engineered products in the EU
Biomed Mater Eng.
2010.
Abstract
The EU Regulation on Advanced Therapy Medicinal Products (ATMP) bridges a regulatory gap and is expected to act as an enabler for the regenerative medicine sector in the EU by setting a centralised and harmonised regulatory framework for tissue-engineered products. Some of its key features are a workable and comprehensive scope, a new committee allowing for a pooling of expertise and tailored yet flexible requirements meant to keep pace with technology development. However, while providing a much needed regulatory framework, the new regulation still has potential shortfalls with regard to facilitating the research and commercialisation of tissue-engineered products in the future.
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