European and international experts discuss the way forward in stem-cell R&D

The European Medicines Agency (EMEA) assembled for the first time European and international experts from academia, regulatory authorities (from Europe, Japan and the USA) and pharmaceutical industry, in a workshop this week, to review opportunities and difficulties in developing stem cell-based therapies and to discuss regulatory challenges.

The workshop was part of the public consultation process on the first dedicated regulatory guidance document on stem-cell research and development. The draft reflection paper builds upon the experience gained so far through extensive dialogue with European experts and pharmaceutical industry and was developed by the Agency's Committee for Advanced Therapies (CAT), together with the Cell-based Products Working Party and Biologics Working Party. "Today's discussion will pave the way for the first European marketing authorisation application for a stem cell-based product," commented Thomas Lonngren, Executive Director of the EMEA.

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