After the entry into force of Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry, the Spanish Agency (AEMPS) becomes responsible for the content maintenance of this website regarding the Ethics Committees.
This Royal Decree defines, within the Ethics Committees for Investigation (CEI), the subgroup of Ethics Committees for Investigation with medicinal products (CEIm), granting the latter the additional responsibility of assessing clinical studies with medicines and/or medical devices. Inquiries regarding the scope of CEIm should be addressed, in general, to aecaem@aemps.es and, when they refer to Information Systems (SIC-CEIC), to incidensayos@aemps.es
Directory of accredited CEIm in Spain
This directory contains information exclusively on the Committees which can evaluate clinical studies with medicines and/or medical devices. The information shows the data which has been provided to the Spanish Agency of Medicines and Medical Devices (AEMPS) by the competent authorities of the Autonomous Communities (CCAA).
A CEIm committed to new Memorandum on Collaboration and work in CTIS must be selected for new clinical trial applications submitted via CTIS. It is important to contact the selected Committee in order to confirm availability to assess the application, as described in the Instruction Document that can be consulted in Regulation section. You can check the Committees committed to CTIS procedure
Information regarding the Committees which can evaluate projects of biomedical research which are not clinical studies with medicines and/or medical devices, can be consulted in here.
