AEMPS UPDATES GCP SECTION

On April 24^th 2019, AEMPS updated the contents of GCP section. Two points were updated:

• New version of serious protocol breaches notification form.

• Prohibition of FDA 1572 form in clinical trials carried out in Spain. Those clinical trials must follow Spanish laws 2001/20/EC, 2001/83/EC y 2005/28/EC and Regulation (EU) No. 536/2014 (when come into force). The non-compliance of this direction will be considered by inspectors a major finding attributable to clinical trial sponsor and principal investigator.

For more information:

• Actualización del Formulario de Notificación a la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) de incumplimientos graves al protocolo de un ensayo clínico autorizado.

• Uso de la forma 1572 en España.