The Spanish Agency of Medicinal Products and Medical Devices informs about the submission of the application for clinical trial authorisation Nº. 1000 via Voluntary Harmonisation Procedure. AEMPS encourages sponsors to continue using this procedure that facilitates clinical trial authorization until the new clinical trial Regulation’s effective application date, foreseen for October 2018.
The Spanish Agency of Medicines and Medical Devices has launched the Spanish Office for support of Innovation and Knowledge of medicinal products in order to integrate coordinate and strengthen the different activities and initiatives supporting investigation, innovation and the obtaining of additional knowledge about new medicinal products performed by the Agency in Spain and within the Framework of the European Medicines Agencies Network.
This publication describes services offered by the Spanish Office for support of Innovation and Knowledge of medicinal products.
The Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices) publishes the second version of the document “How are Medicines and Medical Devices regulated in Spain”. As a public service, the mission of the AEMPS is to give guarantees to the general public on the quality, safety, efficacy and accurate information on medicines and medical devices, in the widest remit, from research to end use, to protect and promote health in both human beings and animals. Its vision is to strengthen the reference health authority for citizens and healthcare professionals with regard to guarantees of quality, safety, efficacy, information and accessibility of medicines and medical devices.