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.
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