Biotech firms cheer EU proposal

More predictable rules for cell, gene and tissue therapies will stimulate innovation, industry says

Stephen Pincock(Stephen.pincock@journalist.co.uk)
Nov 22, 2005

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 Scientist: to create a single, EU-wide regulatory framework to replace the currently "very patchy system" under which member states decide individually how to regulate these products.

The lack of a clear EU-wide structure has meant that individual countries have taken diverging views on...

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