Correspondence: Laure Brévignon-Dodin, Centre for Economics and Policy, Institute for Manufacturing, University of Cambridge, Mill Lane, Cambridge CB2 1RX, UK. Tel: +44 1223 339 739; Fax: +44 1223 339 975; E-mail: ld308@cam.ac.uk

¹is a research associate at the Institute for Manufacturing, Cambridge University. She investigates the regulatory environment for emerging industries and designs regulatory strategies to support the economic sector.

²is medically qualified and currently working for his PhD degree in the Healthcare Engineering Group at Loughborough University. His work investigates the regulatory environment for the emerging regenerative medicine industry along with identifying other enabling challenges in the transition of cell-based technologies into safe and commercially viable products.

^*Contributed equally

Received 5 August 2008; Revised 5 August 2008; Published online 11 November 2008.

Abstract

Regulatory divergences and market fragmentation across member states have hampered the development of the tissue engineering industry in the EU. Addressing this situation by providing a harmonised and more predictable regulatory regime, the regulation on advanced therapy medicinal products (ATMPs) is based on a regulatory strategy that aims to consolidate the increased activity in the domain of regenerative medicine while maintaining the pace of technical development and innovation in this area. The regime draws together the professional expectations of ATMP developers by aiming for a harmonised market access and for providing legal certainty for all stakeholders and concurrently assuring safety and quality of these products to render highest standard of health protection to patients. Still a work in progress as its technical guidelines are in drafting and as it will only apply from December 2008, the ATMP Regulation, which comprises several small and medium sized enterprises (SMEs) friendly provisions, is nevertheless anticipated to have significant impacts on developers. This paper considers some of them.