CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)

CA - Submission for authorisation mandatory for

Clinical IMP trials
Clinical ATMP trials

CA - Submission required to

National CA

National trial registry - Registration mandatory

Yes

National trial registry

Official national registry in Spain: REec
- Registro Español de Estudios Clínicos (Spanish National General Registry of Clinical Studies)
It is mandatory to register the clinical trial in a registry according to Art 62 (on transparency) of Law 29/2006 on Medicinal Products and Medical Devices.

There is no general national healthy volunteer registry.

Applicable national legal framework/ Reference

Royal Decree (RD) 1090/2015

Additional Information

Observational studies:
All studies have to be approved by EC. Depending on the type of study, they will also have to be approved by local/national CA. Please refer to: see: Orden SAS/3470/2009)
In case of doubt regarding the classification of the study, please send an email to: farmacoepi@agemed.es, requesting AEMPS to provide a classification.

Registries: for further information on registries with IMPs and MD, please refer to:
http://www.aemps.gob.es/informa/notasInformativas/laAEMPS/2013/NI-MUH_07-2013-reec.htm

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395