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Unifican fecha de implementación de las guías de evaluación para medicamentos biológicos – Resolución 553 de 2017
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El Ministerio de Salud y Protección Social mediante la Resolución 553 de 2017 establece que la entrada en vigencia de la Guía de Estabilidad de Medicamentos Biológicos y la Guía de Evaluación de la Inmunogenicidad para los Medicamentos Biológicos, entrarán a regir en la misma fecha, es decir, a partir de 17 Agosto de 2017.
Cabe recordar que la Guía de Estabilidad de Medicamentos Biológicos fue expedida en agosto 17 de 2016 mediante la Resolución 3690 de 2016, y que la Guía de Evaluación de la Inmunogenicidad para los Medicamentos Biológicos fue expedida el 27 de septiembre de 2016 a través de la Resolución 4490 de 2016, en los dos actos administrativos se establecía que cada guía empezaría a regir un año después de ser expedida la resolución.
No obstante, con el fin de cumplir con lo establecido en los artículos 22 y 23 del Decreto 1782 de 2014 y de la urgencia de su implementación, es necesario que las dos guías entre a regir en la misma fecha.
Además, en la Resolución 4490 de 2016, existen factores relacionados con el producto, con el paciente y con la enfermedad que pueden afectar la inmunogenicidad de los medicamentos biológicos, elementos que son críticos para la evaluación de riesgo de la inmunogenicidad, y por lo tanto, la evaluación, gestión y mitigación de la inmunogenicidad, está determinada por el análisis del caso concreto (Lea:Médicamentos Biológicos quienes si y quienes no: 4 listados fundamentales)
Modificaciones a la Resolución 4490
Sumado a ello, tras la expedición de la Resolución 4490 de 2016, el Ministerio de Salud y Protección Social recibió observaciones por parte de los gremios de la industria farmacéutica y de la sociedad civil, relacionados con los artículos y su anexo, referentes a los procesos de renovación de registro sanitario, farmacovigilancia, exenciones para los ensayos clínicos de inmunogenicidad confirmatorios y la entrada en vigencia de la misma.
Atendiendo la solicitud la Resolución 553 de 2017 modifica los artículos 2, 5 y 8 de la Resolución 4490 de 2016, este último establece la nueva fecha de entrada en vigencia de la Guía de Evaluación de la Inmunogenicidad para los Medicamentos Biológicos. La resolución también modifica el artículo 4.5 del Anexo Técnico.
La Resolución 553 de 2017 entra en vigencia a partir de su publicación
Descargue: Resolución 553 de 2017 – Unificación de fecha de las guías de evaluación para medicamentos biológicos
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