Development of a cell-based medicinal product: regulatory structures in the European Union.

INTRODUCTION: New therapies with genes, tissues and cells have taken the emerging field for the treatment of many diseases. Advances on stem cell therapy research have led to international regulatory agencies to harmonize and regulate the development of new medicines with stem cells. SOURCES OF DATA: European Medicines Agency on September 15, 2012. AREAS OF AGREEMENT: Cell therapy medicinal products should be subjected to the same regulatory principles than any other medicine. AREAS OF CONTROVERSY: Their technical requirements for quality, safety and efficacy must be more specific and stringent than other biologic products and medicines. GROWING POINTS: Cell therapy medicinal products are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. AREAS TIMELY FOR DEVELOPING RESEARCH: The development of cell therapy medicinal products constitutes an alternative therapeutic strategy to conventional clinical therapy, for which no effective cure was previously available.