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.
Direct access to the information published to date by the AEMPS and the Ministry of Health, Social Services and Equality.
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.