Europe's biotech industry has given a warm welcome to proposals put forward by the European Commission last week for new regulations governing the way that tissue engineered products are approved and marketed in the EU.
The Commission's proposal on "advanced therapies", published on November 16, covers gene therapy, cell therapy and tissue engineering treatments under a single regulatory framework. Primarily, it envisages the establishment of a central marketing authorization procedure that would allow companies working in those fields direct access to the EU market.
"The basic motivation for the regulation is very simple," Gregor Kreuzhuber, the European Commission's spokesman for enterprise and industry, told
The lack of a clear EU-wide structure has meant that individual countries have taken diverging views on the classification ...
