The new regulation on clinical trials in Spain

Written on 21 Jan 2016

The approval of Royal Decree 1090/2015, of 4 December, on clinical trials with medicinal products places Spain ahead of Europe in the regulation of clinical studies, making feasible the current and future application of Regulation (EU) No. 534/2014 of 16 April 2014.

The new European regulation and the Spanish Royal Decree on clinical trials appear in order to find answers and to deal with the continuous criticism that the former legislation repealed received, consisting, mainly, in the excessive bureaucracy and administrative procedures required to conduct a clinical trial.

The main measures introduced by the new decree to deal, not only with the abovementioned disapprovals but also with the new European landscape, are based on the inclusion of principles aimed at simplifying clinical studies on medicinal products in Spain, in addition to supporting the creation of knowledge, transparency and usefulness of results, always with the highest standards of patient safety. 

Specifically the key novelty in this regulation is the introduction of the concept “one single application” that, with the authorization from and the positive resolution of an official Ethics Committee as well as the approval of the Spanish Agency of Medicines and Medical Devices (AEMPS), a clinical trial could be conducted without the need to obtain an authorization from each Ethics Committee of the health centres where the clinical trial may take place. Furthermore, it sets out highly regulated evaluation cut-off dates, it maintains the concept of tacit authorization and it reduces the authorization time limits, thus, promoting the development of clinical studies.

Additionally, the new decree aims to make the system more transparent and accessible. This would require clinical trials, as well as the centres in which they are being conducted, to be registered with the Spanish Registry of Clinical Trials, as well as being free and available to any citizen who wishes to access and consult an authorized clinical trial.

It also aims to provide more protection to subjects participating in clinical trials by setting out, as a general principle for approving a trial, the protection of the rights, security, dignity and wellbeing of said subjects above any other interest. For this purpose, the obligations of the organizer will be tightened in relation to the selection and monitoring of the subjects in a trial. Likewise, the evaluation periods of these subjects are reduced.

One of the regulation’s newest features is the introduction of the “low intervention clinical trial” category for which laxer regulations are being called for concerning monitoring aspects, the content of the master file or traceability issues, without it affecting the security of the subjects taking part in these trials. According to the director of the AEMPS, this clinical trial category will further clinical trials that have no commercial aim, and this can add considerable knowledge on authorized medicinal products which have already been authorized.

Despite the European Regulation not coming into effect until May 2016, by adapting the new Spanish regulations, Spain aims to back the sector of clinical trials and make the country a more attractive place to its European partners, in addition to gaining competitiveness both in European and global clinical studies.