The regulatory framework applicable to stem cell therapy is required to incorporate the provisions of a European Union Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

The Directive will apply ,amongst other things, to cellular stem-cell-derived materials that are intended for human application ,but not to preceding "in vitro "research. The Directive was agreed in March 2004 and member states are obliged to implement it by April 2006.

The new Directive provides:

• the establishment of a register of the entities operating in this field across the EU
• minimum quality and safety systems
• professional requirements and training necessary
• provisions for inspections and penalties in the member states
• mandatory minimum standards and procedures for the donation, testing, procurement, processing, storage, distribution and preservation of tissues and cells