title: Development of a cell-based medicinal product: regulatory structures in the European Union.
abstract: BACKGROUND
  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.
  
  
  METHODS
  European Medicines Agency on September 15, 2012.
  
  
  RESULTS
  Cell therapy medicinal products should be subjected to the same regulatory principles than any other medicine.
  
  
  RESULTS
  Their technical requirements for quality, safety and efficacy must be more specific and stringent than other biologic products and medicines.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  The development of cell therapy medicinal products constitutes an alternative therapeutic strategy to conventional clinical therapy, for which no effective cure was previously available.
authors.affiliation: Avenida Américo Vespucio s/n, Seville, Spain. patricia.galvez@cabimer.es
authors.forename: Patricia
authors.initials: P
authors.lastname: Gálvez
authors.forename: Beatriz
authors.initials: B
authors.lastname: Clares
authors.forename: Abdelkrim
authors.initials: A
authors.lastname: Hmadcha
authors.forename: Adolfina
authors.initials: A
authors.lastname: Ruiz
authors.forename: Bernat
authors.initials: B
authors.lastname: Soria
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000706:statistics & numerical data*; D002908:Chronic Disease / Q000628:therapy*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D008511:Medicine; D011634:Public Health / Q000331:legislation & jurisprudence