The new legislation for clinical trials simplifies procedures, increases patient guarantees and encourages transparency.

The Spanish Council of Ministers, at the proposal of the Ministry of Health, Social Services and Equality, passed today a Royal Decree regulating clinical drug trials, ethics committees for research with drugs and the Spanish Clinical Studies Registry. Thanks to this new legislation, Spain will progressively adapt to the new EU regulations on clinical trials, which will come into force in May 2016.

By virtue of this project, and as established in the regulations, Spain will maintain a unique and common position as member state simplifying procedures to initiate clinical trials while increasing patient guarantees.

Spain currently takes part in approximately 18% of all clinical trial conducted in Europe. In addition, most of the clinical trials conducted in our country are multicentre and multinational studies. This new legislation is set to maintain and reinforce Spain's competitive position.

On the one hand, it simplifies the bureaucracy. Until now, for a clinical trial to be authorised in Spain, it had to be submitted to the ethics committee of each health centre taking part in the trial. If 20 centres were taking part, it needed 20 approvals, in addition to the approval from the Spanish Agency for Medicines and Medical Devices (AEMPS). With the new Royal Decree, the clinical trial will only need the approval from one accredited ethics committee and from the AEMPS. The sponsor organisation will also be able to negotiate the approval with the centres while waiting for the ethics committee and the AEMPS to evaluate and approve the trial, which will shorten the whole submission process and attract foreign drug research.

The Royal Decree also increases the patients' involvement in decisions that will affect them, as it will now be compulsory to include patients in the ethics committee.

On the other hand, the Royal Decree also promotes non-commercial research, that is, trials not promoted by the pharmaceutical industry. The role of sponsor of non-commercial clinical trials is therefore created to encourage research within the Spanish healthcare system, universities and institutions with outstanding researchers in areas that are not always a priority for the industry.

The new legislation also covers the regulation of the Spanish Clinical Studies Registry (REec), available on, as a transparency measure that grants free access to information on all clinical trials authorised in Spain and the organizations taking part in them.

In short, this Royal Decree will encourage clinical research with drugs in Spain while generating knowledge and promoting transparency, the security of those taking part in the trials and the usefulness of the outcomes. The main goal, to increase trust in research and encourage its progress.

Link to the Spanish official state bulletin

Symposium on the new Royal Decree. 27th January 2016. More information (in Spanish)



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