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The new Royal Decree Law allows for a 19% time reduction when starting a new clinical trial in Spain, just six months after coming into force

15:01 Farmaindustria
Farmaindustria publishes updated data from the BEST project (June 30th) demonstrating the positive effect of this legislation

Barcelona, October 19th 2016.- The Royal Decree Law 1090/2015 regulating clinical trials has allowed, since it’s coming into force last January 13th, that the time needed to kick off a new clinical trial in Spain is reduced by more than a month (19%) in Spain. This is reflected in the data from the BEST project’s , updated on June 30th this year, which was presented today in Barcelona, during the 1st National Meeting of ethic committees in medicines research (CEIm), organized by the Spanish Medicines Agency (AEMPS) in collaboration with the Spanish Clinical Pharmacology Society. The pharmaceutical industry is confident that these timelines will be further reduced in the upcoming months.

The BEST project, started more than ten years ago, gathers  together 45 pharmaceutical companies, 13 Spanish Regions, 57 hospitals, both public and private, as well as  four independent research groups. The figures released today demonstrate that all agents participating in this initiative have undertaken great efforts to adjust to the timelines established in the new Royal Decree. The reduction of the timelines needed to set up a new clinical trial in Spain is a direct consequence of these efforts, passing from an average 190 days with the former regulation to 154 in the first semester of 2016, which stands for 19% less time.

Amelia Martín Uranga, Head of the Spanish innovative Medicines Platform at Farmaindustria, has especially remarked upon the timelines set by the AEMPS for the authorization of said trials, which in some cases have been reduced by more than 20 days. The Spanish pharmaceutical trade  association also acknowledged the effort made by the AEMPS since the new Guidelines Document came into force, which  intends to be a dynamic tool in constant revision, which has in turn become a great aid for sponsor companies, stated Martín Uranga.

The work undertaken by the Ethic Committees aimed at meeting the deadlines established by the new Royal Decree is equally valued by the pharmaceutical industry, since this regulation requires a better supply of technical resources and a better frequencies in their meetings. Martín Uranga has explained that the suspendible condition required by this new regulation is a determining factor when facilitating the reduction of timelines as far as the signature of contracts is concerned.

Investments of more than €1000 M  

The updated data released today by the BEST project in Spain also reflects the commitment of the Spanish pharmaceutical industry to R&D in 2015, a term in which companies invested € 1,004 Min projects within this field, which accounts for an increase of 5.4% compared to the previous year, according to the R&D survey carried out by Farmaindustria amongst its members on an annual basis. The sector maintains its position in undertaking clinical trials in earlier phases. Good proof of the latter was the third update of the Spanish Earlier Phases Units guideline published one year ago.

During the meeting held in Barcelona, Farmaindustria stressed its satisfaction at Spain being the first county incorporating the European Clinical Trials Regulation into its national legal framework, which will allow Spain to be prepared as soon as the text becomes effective in all Member States.

Martín Uranga highlighted in this event that the working methods fromthese past few months between representatives of the pharmaceutical industry, AEMPS, CEIm, researchers and patients, as well as the regions’ research directors and hospital centers, have always been led by fluid dialogue and the search for consensus when drafting the documents and new procedures which were relevant for the production of the new Royal decree.

The effective application of this new regulation poses new challenges, but it also constitutes a clear opportunity to consolidate Spanish position as one of the best countries in Europe to undertake clinical research, with the main objective of making it easier for patients to access the most innovative medicines, while researchers and promoters can feel backed up and stimulated by a first class scientific, ethical and legal environment.

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Department: Comunicación Farmaindustria


Phone: 915 159 350


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