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Buenas Prácticas en Medicamentos Biológicos
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Hoy Consultorsalud pone a su disposición el documento Buenas Prácticas de Manufactura de medicamentos biológicos, cuyo trámite se encuentra ya descrito en el plan de trabajo para la reglamentación del Decreto 1782 de 2014, y que está en calidad de proyecto normativo, y terminó su fase de recibo de opiniones el pasado 4 de mayo en el Minsalud.
El 18 de septiembre de 2014 se firmó el Decreto 1782 de medicamentos biológicos que regula su registro sanitario, garantizando la seguridad y eficacia de este tipo de medicinas y permitiendo a los pacientes disponer de alternativas terapéuticas de igual calidad y menor precio.
La ruta abreviada es para medicamentos muy conocidos y con sustancias químicas totalmente caracterizadas, es decir que se conocen sus propiedades fisicoquímicas.
Al conocer con exactitud el comportamiento del ingrediente farmacéutico activo es posible concluir que funcionará de manera similar a otros medicamentos que contienen esa misma sustancia y por lo tanto no es necesario repetir todos los experimentos con animales y humanos, ni hacerlos tan complejos y extensos.
Para las tres rutas se debe presentar un paquete de experimentos y pruebas. Estos son requisitos indispensables, entre ellos las pruebas de inmunogenicidad, determinantes para la seguridad de los medicamentos.
Descargue: Buenas Prácticas de manufactura de medicamentos biológicos
Este artículo tiene documentos adjuntos que podrá descargar para ampliar su información:
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