NLClinicalTrialsIMP object

General Act(s) on Medical/Clinical Research in Humans
Transposition of (CT) Directive 2001/20/EC
Transposition of (GCP) Directive 2005/28/EC
Other

Royal Decree 1090/2015 (Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos): regulating clinical trials with medicinal products.

It supersedes Royal Decree 223/2004 (Real Decreto 223/2004, de 6 de febrero) on interventional clinical trials with medicinal products (no longer applicable).

Available as separate legal text

Ordinance SCO/256/2007 (Orden SCO/256/2007, de 5 de febrero) is the implementation of Directive 2005/28/EC (GCP Directive) into Spanish law.

Law 29/2006 on Medicinal Products and MD (Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios):
It regulates aspects related to medicinal products and medical devices such as clinical research, assessment and authorisation, registry, manufacturing, quality control, storage, shipment and distribution, etc.

(1) Law 14/2007 (Ley 14/2007, de 3 de julio, de Investigación biomédica - in Title V Chapters I-IV): It deals with biomedical research in general, focusing on interventional studies (except for clinical trials on medicinal products, on medical devices, on cells/Tissues/ organ transplants), non interventional studies, data protection and ethical aspects. It also covers genetic analyses, management and storage of biological samples and biobank regulation.
(2) Royal Decree 1716/2011 (Real Decreto 1716/2011, de 18 de noviembre): This Decree refers to Ley 14/2007 and provides detailed information on the basic requirements of authorization and functioning of biobanks for biomedical research and the management of human biological samples, and regulating the functioning and organization of the National Registry of Biobanks for biomedical research
(3) Observational studies:
Orden SAS/3470/2009, de 16 de diciembre, covers postauthorization (observational) studies with MP for human use.

Data protection: Data Protection. Orden SAS 3470/2009, Law 15/1999 and RD 1720/2007