title: [Regulatory procedures of non-interventional post-authorization studies in Spain].
abstract: This article describes the administrative and legal requirements to carry out non-interventional post-authorization studies in Spain.
authors.affiliation: Unidad de Ensayos Clínicos de Fase I de Oncología. Fundación Jiménez Díaz. Madrid.
authors.forename: M P
authors.initials: MP
authors.lastname: Vicente Sánchez
authors.forename: D
authors.initials: D
authors.lastname: González Bermejo
authors.forename: D
authors.initials: D
authors.lastname: Macías Saint-Gerons
authors.forename: C
authors.initials: C
authors.lastname: de la Fuente Honrubia
mesh_terms: D017277:Drug Approval; D017408:Guidelines as Topic; D006801:Humans; D017891:Pharmacoepidemiology; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D013030:Spain