title: [Procedure for the marketing authorization of an antibacterial agent].
abstract: The marketing authorization of a new medicinal product is the first step before being placed on the market, and includes the full investigation programme. In order to ensure their quality, safety and efficacy, medicinal products are closely regulated from their initial phases of investigation to their use in clinical practice. For registration purposes, the results of all the clinical and preclinical studies, along with quality data and the description of the manufacturing process should be submitted. All information collected is presented for review by the competent authority. The European Medicines Agency regulates the registration of medicines in Europe, and national agencies in each EU member state are responsible for the assessment of the marketing authorisation application. To facilitate the development of clinical programmes, there is a common framework for the evaluation of an antibacterial, which includes guidelines and an addendum, detailing the specific requirements that must be carried out in clinical trials to assess the efficacy and safety for most of the infections.
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Madrid, España. Electronic address: alopezn@aemps.es.
authors.forename: Antonio
authors.initials: A
authors.lastname: López Navas
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Madrid, España.
authors.forename: Nuria
authors.initials: N
authors.lastname: García-Escribano Ráez
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Madrid, España.
authors.forename: Ángela
authors.initials: Á
authors.lastname: Flores Juberías
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Madrid, España.
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Suárez Gea
mesh_terms: D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy; D002986:Clinical Trials as Topic / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004353:Drug Evaluation, Preclinical; D024901:Drug Resistance, Multiple, Bacterial; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D040541:Marketing
chemical_list: D000900:Anti-Bacterial Agents
keywords: Agencias reguladoras; Antibacterial; Antibacteriano; Guidelines on the evaluation of antibacterials; Guía de evaluación de antibacterianos; Marketing authorisation; Registro; Regulatory agencies