Mediante el decreto 1782 de 2014 se establecen los requisitos y procedimientos para las evaluaciones farmacológicas y farmacéuticas de los medicamentos biológicos en el trámite del registro sanitario.
Se basa en lo dispuesto en el artículo 189 en el numeral 11 de la Constitución Política, el artículo 245 de la Ley 100 de 1993 y el artículo 89 de la Ley 1438 del 2011.
El decreto firmado el día de ayer (18 de septiembre) por el Presidente de la República y el Ministro de Salud, aplica para “las personas naturales o jurídicas que desarrollan actividades de fabricación, importación y comercialización de medicamentos biológicos”, como de todos “los medicamentos biológicos que estén o no incluidos en las normas farmacéuticas”.
Para su aplicación se tendrá en cuenta la definición de los medicamentos biológicos que se enuncian como “medicamentos derivados de organismos o células vivas o sus partes” y que se obtengan de fuentes como “tejidos o células, componentes de la sangre humana o animal” entre otros conceptos y los medicamentos de referencia que son aquellos que su registro sanitario ya ha sido autorizado por el Invima u otras agencias sanitarias autorizadas.
Dentro del decreto se fijan: los reglamentos de Evaluación Farmacológico de Medicamentos Biológicos en su eficacia y seguridad; las rutas de presentación de información para la evaluación farmacológica (por expediente completo, de comparabilidad y abreviada de comparabilidad) y los requisitos de Información común de las tres rutas. Además de los criterios para la evaluación farmacológica que tendrá en cuenta criterios de: evidencia global y complejidad de la molécula.
Se establece, asimismo, la Evaluación Farmacéutica y Buenas Prácticas de Manufactura de Medicamentos Biológicos que exige los requisitos de información para la evaluación farmacológica consignados en el artículo 22 del Decreto 677 de 1995.
Los laboratorios fabricantes de medicamentos biológicos deben obtener el certificado de evaluación de las buenas prácticas de manufactura que será reglamentado por el Ministerio de Salud y que se acoge a los informes técnicos emitidos por la Organización Mundial de la Salud- OMS.
Se insta adicionalmente las evaluaciones para el registro sanitario de los medicamentos biológicos como: adaptación y adopción de las guías de inmunogenicidad, plan de gestión de riesgo y estabilidad que expedirá el Ministerio a los doce meses siguientes de presentado el decreto.
Finalmente se dan los criterios de Farmacovigilancia y vigilancia sanitarias, entre otras disposiciones.
Este Decreto entra en vigencia a partir de su publicación.
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Decreto 1782- Medicamentos Biotecnológicos
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