NLGeneralInformation object
Yes
A list of the International standards as well as European and Spanish legislation regarding medical research is provided on the AEMPS website: Inicio >Legislación>España>Investigación (in Spanish only)
Yes
Agencia Estatal Boletín Oficial del Estado (BOE- State Agency Official State Gazette)
Legal framework for clinical trials with medicinal products
- Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products : Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios. (BOE núm. 177, de 25 de julio de 2015).
Available at (only in Spanish) : https://www.aemps.gob.es/en/legislacion/espana/laAEMPS/general.htm#leyes
- Corrección de errores del Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios. (BOE núm. 306, de 23 de diciembre de 2015).
Available at (only in Spanish) : https://www.aemps.gob.es/en/legislacion/espana/laAEMPS/general.htm#leyes
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Background
The Royal Decree Royal Decree 1090/2015 aims to adapt the Spanish legislation to the future application of the Clinical trials - Regulation EU No 536/2014 of 16 April 2014. Also, it aims to cover those aspects that are subject to national adaptations as well as any others aspects requiring clarification ( for instance, the decree provides a definition of "non commercial trials". See definitions)
This Royal Decree entered into force in January, 2016, except for a few paragraphs, which shall enter into force on the date on which the Regulation (EU) No. 536/2014 will enter into application.
Pending the application of the aforementioned EU Clinical trial regulation (no sooner that 2019) and the development of a fully functional EU clinical trials portal and database, the Spanish Royal Decree has established the following transational procedure :
- transitional procedure for authorization of a clinical trial before full functionality of the EU portal and the EU database
- transitional arrangements relating to the functions of evaluation of the ethics committee (currently called "CEICs") ( for instance, according to the Decree, only the accredited ethics committees as CEIms - Committees on Ethics of Research with Medicines - will be able to evaluate the clinical trials with medicinal or healthcare products)
