title: [Non-interventional post-authorisation studies in Spain: justification and basis of a new regulation].
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Ministerio de Sanidad y Política Social, Madrid, España.
authors.forename: César
authors.initials: C
authors.lastname: De La Fuente Honrubia
authors.forename: Francisco José
authors.initials: FJ
authors.lastname: De Abajo Iglesias
authors.forename: Javier
authors.initials: J
authors.lastname: García Del Pozo
authors.forename: Emilio
authors.initials: E
authors.lastname: Vargas Castrillón
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D017041:Ethics Committees; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000592:standards; D011446:Prospective Studies; D012107:Research Design / Q000592:standards; D013030:Spain
vernacular_title: Estudios postautorización de tipo observacional en España: justificación y bases de una nueva normativa.