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La Agencia Europea del Medicamento (EMA) ha publicado recientemente una guía con el objetivo de “apoyar la implementación de un nuevo estándar internacional para el control de la seguridad de los medicamentos en la Unión Europea”, con el cual busca mejorar en este ámbito a partir de su introducción el 1 de julio del año 2016.
Etiquetas: 1 de julio del 2016, 21 de enero de 2015, 4 diciembre 2014, Agencia Europea del Medicamento, Bruselas, Control, EMA, estándar, European Medicines Agency, Guía, HMA, Implementación, informe, medicamentos, salud, Sanidad, seguridad, UE, Unión Europea.
La Agencia Europea de Medicamentos (EMA) ha publicado un folleto ilustrado que explica cómo funciona el sistema regulador europeo de medicamentos.
En concreto, el documento describe cómo se autorizan y supervisan los medicamentos en la Unión Europea (UE) y cómo funciona la Red europea de regulación de medicamentos, una asociación entre la Comisión Europea, las 50 autoridades reguladoras de medicamentos de la Unión Europea y del Espacio Económico Europeo (EEE), y de la EMA.
Etiquetas: 2014, Agencia Europea de Medicamentos, EMA, Espacio Económico Europeo, European Medicines Agency, European regulatory system for medicines, Guidelines, Heads of Medicines Agencies, HMA, Londres, Medicines, Red europea de regulación de medicamentos, salud, Sanidad, Sistema regulador europeo de medicamentos, Unión Europea.
Etiquetas: Background, Clinical trials facilitation group, CTFG, Definitions, Flow-charts, Formal CTA, General principles, Heads of Medicines Agencies, Health, HMA, HMAs, March 2010, Medication, Medicinal products, National step, Rationale, Request for VHP, salud, Sanidad, Substantial amendments, Timelines of substantial amendments, VHP, Voluntary Harmonisation Procedure.
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