Revisions to the EU Clinical Trials Directive legislation in Portugal will standardise the way clinical trials are performed in the country and improve timelines to competitive levels
That will make Portugal an important player in the clinical trials market, according to Beatriz Mosqueira, clinical project manager at independent clinical research organisation Chiltern International.
"One of the biggest changes from the current legislation will be that only a single opinion will be given by a central ethics committee," added Mosqueira.
This, together with new timelines imposed by the directive, will enhance Portugal's appeal as a location for clinical trials, which are already on the increase.
"Recently, the Directive has been implemented into national legislation (Lei No 46/ 2004) on 19 August 2004, however, the precise procedures might not be in place until later in the year," commented Elena Ortiz, Chiltern's senior regulatory officer.
"During this time the old processes will apply but the new forms will be used".
In addition to beneficial legislation, Portugal also has a high number of universities and central hospitals concentrated in major cities such as Lisbon, Oporto and Coimbra. As a consequence, most investigators from these hospitals will have significant experience in conducting clinical trials. "Patient referral is already highly efficient" according to Sofia Batista, one of Chiltern's clinical research associates who has considerable experience in Portugal. "The clinical trials environment in Europe is changing and the implementation of Clinical Trials Directive 2001/20/EC in the various countries is homogenising the procedures to follow in all member states," explained Beatriz Mosqueira.
"The interest taken by the pharmaceutical industry in the research field has played a major part in the therapeutic progress achieved in the second half of the 20th century.
"Portugal, along with Spain and many other countries, has increasingly understood the potential of this symbiotic relationship."
