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El reglamento de ensayos clínicos europeo cambiará para el 2022
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El Diario Oficial de la Unión Europea confirmó que el nuevo Reglamento de ensayos clínicos se empezará a aplicar formalmente a partir del 31 de enero del próximo año. Con esta nueva reglamentación se espera que el portal y la base de datos de ensayos clínicos del Espacio Económico Europeo sea completamente funcional ya que hace parte importante de la reforma al reglamento.
Tanto la base de datos como el portal son parte del componente principal del Sistema de Información de Ensayos Clínicos -CTIS de la UE, con este sistema se dará soporte y seguimiento a los nuevos objetivos del reglamento que busca principalmente agilizar el procedimiento de solicitud, evaluación y supervisión de los ensayos clínicos para que los países del viejo continente sigan manteniéndose a la vanguardia de la investigación clínica.
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El CTIS articulado con otros sistemas gestionados por la Agencia Europea del Medicamentos –EMA– facilitarán la evaluación de las tecnologías médicas contribuyendo a la comprensión de los beneficios y riesgos de los medicamentos en investigación. con el tiempo se espera que este sistema se convierta en el único punto de recepción de solicitudes de ensayos clínicos comprendiendo todos los países de la Unión Europea, pero también Islandia, Liechtenstein y Noruega. Recordemos, que en la actualidad para que una compañía obtenga una autorización de ensayos clínico debe enviar una solicitud individual a cada país sin importar si es miembro de la UE. Con el CTIS este proceso sufrirá el cambio más importante de los últimos años ya que con un único envío se podrá solicitar autorización hasta en 30 países.
Adicionalmente, facilitará el reclutamiento de voluntarios para ensayos clínicos, ayudando a los investigadores a expandir los ensayos clínicos a otros países y dará soporte a la colaboración internacional para mejorar los resultados. Del mismo modo, en el sistema se almacenarán los datos sobre los ensayos que se realicen y sus resultados mejorando la trasparencia y acceso a la información de cualquier interesado.
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Tres años para acoger el nuevo reglamento de ensayos clínicos
El Reglamento de ensayos clínicos prevé un periodo de transición de tres años, aunque los Estados miembros trabajarán en el entorno de CTIS desde el día de su puesta en marcha. Por su parte, los solicitantes, hasta el 31 de enero de 2023, podrán elegir el envío de solicitudes de autorización de ensayos mediante el sistema actual (solicitudes individuales por país, previstas en la Directiva de ensayos clínicos) o según el procedimiento marcado por el nuevo reglamento.
No obstante, a partir del 31 de enero del 2023 todas las solicitudes deben enviarse a través de CTIS y a partir del 31 de enero de 2025 todos los ensayos en marcha autorizados deberán haber aplicado la transición al nuevo reglamento y estar registrados en CTIS.
Finalmente, la EMA elaboró un programa de formación para ayudar a los promotores, Estados miembros y comités de ética a usar CTIS y adoptar el nuevo reglamento de ensayos clínicos.
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