ABSTRACT
El registro de un nuevo medicamento es el paso previo a la comercialización y culmina todo el proceso de investigación. El medicamento está ampliamente regulado desde su investigación hasta su utilización, con el fin de garantizar la calidad, la seguridad, la eficacia y la correcta información del mismo. Para su registro se deben presentar los resultados de todos los estudios preclínicos y clínicos junto con los datos de calidad y la descripción del proceso de fabricación. Se recopila todo el material y se presenta para su revisión por el organismo correspondiente. La European Medicines Agency regula el registro de los medicamentos en Europa, y las agencias nacionales en cada país miembro de la Unión Europea son las responsables de la evaluación de toda la documentación. Para facilitar el desarrollo de los programas clínicos existe un marco común para la evaluación de un antibacteriano, que incluye una guía y un anexo a la misma, en el que se detallan los requisitos específicos que deben tener los ensayos clínicos que se lleven a cabo para evaluar la eficacia y la seguridad en las indicaciones que son más habituales en el registro de antibacterianos
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
Subject(s)
Humans , Anti-Bacterial Agents/pharmacology , Pharmaceutical Trade , Drug Approval/methods , Drug Evaluation/methods , Products Registration , Drug Evaluation, Preclinical , Treatment Outcome , Drug Resistance, MultipleABSTRACT
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.
