title: Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research.
abstract: The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered. With the evolution of therapy that uses cells as medicines, there is a need to develop the appropriate legislative and regulatory framework capable of ensuring their safety and effectiveness. However, few works have been published regarding the regulations that these products must comply through production and commercialization processes. The present work is focused on the description of key events during clinical development and cell production of stem cells as drugs. Such as the regulations, requirements and directives involved in the production of cell therapy medicinal products, from the clinical design stage to its commercialization in Europe.
authors.affiliation: Cellular Production Unit, Andalusian Molecular Biology and Regenerative Medicine Centre (CABIMER), Americo Vespucio Avenue s/n, 41092, Seville, Spain, patricia.galvez@cabimer.es.
authors.forename: Patricia Gálvez
authors.initials: PG
authors.lastname: Martín
authors.forename: Adolfina Ruiz
authors.initials: AR
authors.lastname: Martinez
authors.forename: Visitación Gallardo
authors.initials: VG
authors.lastname: Lara
authors.forename: Beatriz Clares
authors.initials: BC
authors.lastname: Naveros
mesh_terms: D035843:Biomedical Research; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D017277:Drug Approval; D005062:European Union; D006801:Humans; D033581:Stem Cell Transplantation / Q000379:methods*