Entries Tagged 'EMEA' ↓

ChondroCelect is First Advanced Therapy Medicinal Product Approved in EU

For those following the commercialization of regenerative medicine products, there has been some promising news this month. Tigenix, based in Belgium, received authorization on October 09, 2009 from the European Commission to market ChondroCelect, its autologous chondrocyte implantation (ACI) product.  This is the first medicinal product to be approved as an Advanced Therapy Medicinal Product (ATMP).  While this may not be the most exciting example of a regenerative medicine product, I do consider it important from the regulatory perspective in that it validates that cell-based products can be approved under the ATMP regulation.

If anyone has insights regarding other regenerative medicine products that may be approved in the near futue in the EU, I’d love to hear about them in the comments.

–Darin