title: Drug evaluation and approval process in the European Union.
authors.affiliation: Spanish Agency for Medicines and Health Care Products, Alcalá 56, 5o, 28014 Madrid, Spain. msanmiguel@agemed.es
authors.forename: M Teresa
authors.initials: MT
authors.lastname: San Miguel
authors.forename: Emilio
authors.initials: E
authors.lastname: Vargas
mesh_terms: D017277:Drug Approval / Q000379:methods / Q000458:organization & administration*; D004341:Drug Evaluation / Q000379:methods; D004345:Drug Industry / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans