EU-wide regulatory framework for advanced therapies

The industry welcomes the Commission's proposal as it lays down "the long-awaited harmonized rules for the approval and marketing of human tissue engineered products in the EU".  

Eucomed, the European association representing the majority of companies active in human tissue engineering in the EU: "A large share of the potential world-wide market estimated up to 400 billion euro will become accessible to the EU, if an appropriate harmonized framework is put in place. This in turn could make a substantial contribution to achieving the Lisbon goals." 

"Eucomed will now analyse the Commission’s proposal in detail. We need to be sure it fully takes account of the specific nature of human tissue engineered products which are neither pharmaceutical products nor medical devices. We also need to check whether it is in line with the approaches adopted in other parts of the world such as the US and whether it can make the EU attractive to foreign investment," said Maurice Wagner, Director General of Eucomed. 

EuropaBio, the voice of European Bioindustries: "The industry welcomes the choice of the Commission to opt for a Regulation in this field rather than a Directive to ensure that optimal and harmonised standards are used wherever a company or patient may be based in Europe."

"Europe is already late in this field yet has very promising technologies to offer. The US has had rules in place for these products for some time, but the field is changing continuously. US companies have benefited from a more predictable legislative environment and clarity. Predictability and clarity are two elements that are very important for companies to find investors prepared to invest in this research," said EuropaBio’s Secretary General Johan Vanhemelrijck.