Affiliations: Institute for Manufacturing, Department of Engineering, University of Cambridge, Cambridge, UK
Note: [] Address for corresponding: Laure Brévignon-Dodin, Institute for Manufacturing, Department of Engineering, University of Cambridge, 17 Charles Babbage Road, CB3 0FS, Cambridge, UK. Tel.: +44 1223 339 739; E-mail: [email protected].
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.
