The AEMPS starts a pilot study to include the opinion of the Ethics Committee (EC) in the assessment conclusions of Clinical Trial Applications undergoing the Voluntary Harmonisation Procedure. The VHP guidance document has been updated.
The identification of an investigational medicinal product requires at least a name for the medicinal product and at least a name for the active substance...
The Spanish Agency of Medicines and Medical Devices announces a new application for submission of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) by the Marketing Authorization Holders.
The Spanish Agency of Medicines and Medical Devices (AEMPS) recommends the submission of the Development Safety Update Report (DSUR) to the AEMPS via the Portal ECM.
The Charter of services of the “Agencia Española de Medicamentos y Productos Sanitarios” (the Spanish Agency of Medicines and Medical Devices) for citizens and users, provides information about the entrusted services, about the rights they have in relation to these services, and about the quality commitments regarding the improvement of public services they render, responding to citizens' and users' demands. This Charter of services is based on the Royal Decree 951/2005 of 29th July, establishing the general framework for quality improvement in the General State Administration.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has launched the Spanish Clinical Studies Registry (REec). The Registry, available on the following website: https://reec.aemps.es, provides information to patients and healthcare professionals about clinical researches approved in Spain, in order to report on ongoing researches on a given disease, syndrome or a related treatment with human medicines.