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Regulación de Ensayos Clínicos en Ecuador

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Regulación de Ensayos Clínicos en Ecuador

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Normas MSP-ARCSA y ética

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Jorge Luis Mendoza Robles
Jorge Luis Mendoza Robles
Ecuador

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Regulación de Ensayos Clínicos en Ecuador
 

Regulación de Ensayos Clínicos en EcuadorOnline version

Normas MSP-ARCSA y ética

by Jorge Luis Mendoza Robles
1

El etiquetado de los productos en investigación puede omitirse o no estar en castellano.

2

El consentimiento informado debe ser obtenido y documentado antes de la participación, según CEISH y ARCSA.

3

ARCSA mantiene un sistema de farmacovigilancia para los reportes de seguridad de productos en investigación.

4

El Reglamento regula la aprobación, autorización, ejecución, vigilancia y control de ensayos con medicamentos y productos naturales.

5

El CEISH es una entidad privada independiente del MSP y no requiere aprobación de ARCSA.

6

Las OIC no requieren registro en ARCSA y pueden operar sin supervisión regulatoria.

7

Los ensayos pueden empezar sin consentimiento informado si es durante una emergencia sanitaria.

8

ARCSA no tiene autoridad para exigir auditorías BPC en centros de investigación clínica.

9

El patrocinador debe contratar una póliza de seguro que cubra daños a participantes y mantenerla por al menos un año después del final.

10

El MSP exige que todos los ensayos clínicos sean aprobados por un CEISH y autorizados por ARCSA.

 
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