On May 20 2013 – which was also International Clinical Trials Day – the Ministry of Health, Social Services and Equality presented a draft royal decree regulating clinical trials, ethics committees for drug research and the registration of clinical studies.(1)

The decree aims to:

  • harmonise the legal regime for clinical trials carried out in Spain with the latest changes and interpretations made at EU level;
  • improve the approval procedure for clinical trials; and
  • establish a framework facilitating the exchange of information among the agents and authorities involved in clinical trials.

The decree sets down the basis for the new Clinical Trials Register, which aims to promote transparency in clinical drug studies and make it easier to access complete and accurate information about them. Following approval of the decree, the Agency of Medicines and Health Products will immediately publish on the register all clinical trials performed with human medicaments that it has authorised (except Phase 1 clinical trials that do not include a paediatric population). At a later stage, the agency will also publish observational studies carried out in Spain. In addition, the agency intends to open up the register to other studies that can be recorded voluntarily. In all cases, sponsors will be obliged to publish the results obtained in the recorded investigations once they are concluded.

The new register will be made available to the public on the agency's website. In addition to the descriptive data required by other international registries and other information, it will include a brief justification of the study, its stage of activity, the participating centres, the baseline dates of the trial and the dates indicating the end of recruitment and trial completion.(2)

For further information on this topic please contact Amparo Campos at Bird & Bird by telephone (+34 91 790 6000), fax (+34 91 790 6011) or email (amparo.campos@twobirds.com).

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Endnotes

(1) Available at www.msssi.gob.es/normativa/docs/Rdensayosclinicosm.pdf.

(2) General information about the Spanish Clinical Trials Register can also be found at www.aemps.gob.es/informa/notasInformativas/laAEMPS/2013/NI-MUH_07-2013-reec.htm.