Regulation of tissue-engineered products in the European Union: where are we heading?

The emergence of tissue-engineered products (TEPs) raises a standard question for regulators: is the existing regulatory regime appropriate or is there a case for a new regulatory framework? In the USA, the FDA has developed a risk-based approach to TEPs, whereas in Europe, a common regulatory strategy for these products has not yet been implemented. In order to fill this perceived gap, member states have set up domestic rules, which has led to an unclear and patchy regulatory situation. The Regulation on Advanced Therapy Medicinal Products, voted on by the European Commission in November 2005, has been developed by European Union regulators to provide the necessary framework to regulate TEPs. As the text is still to be discussed and to be passed, many concerns have been raised regarding the appropriateness of the proposed framework.