Clinical studies take too long to be approved in Romania, study says

Georgeta Gheorghe 24/03/2017 | 07:00

Clinical studies take too long to be approved in Romania, a study made by KPMG for the Romanian Association of International Drug Manufacturers (ARPIM) and Association of Companies that Coordinate Clinical Studies in Romania (ACCSCR) says.

In Romania it takes 25 weeks, three times more than the timeline set by EU regulations, KPMG’s Clinical studies in Romania shows. By contrast, in Hungary the period is 9 weeks, and in the Czech Republic, Ukraine and Lithuania 11 weeks are needed to approve the file of a clinical study. The country’s potential to run clinical studies must be harnessed, as clinical studies have a crucial contribution to the development of new drugs, the study argues.

According to the same report, as it takes this long to approve the clinical studies, their number decreased in Romania from 254 in 2011 to only 184 in 2016.

„Romanian patients need solutions in order to be treated with last generation drugs, given that, for many of them, this type of treatments represent their last or only chance to fight disease. Clinical studies represent such a solution for all countries with a developed health system, which could be taken as an example. A patient enrolled in a clinical study receives an innovative drug, otherwise inaccessible, it monitored permanently and benefits, overall, of medical care of European standards. For the medical community, it means more funds for public hospital and smaller costs for patients,” said Radu Rasinar, ARPIM president.

In 2015, in Romania 192 clinical studies were approved, and the clinical studies industry contributed EUR 98 million to the state budget, including EUR 26 million which represented taxes paid for the clinical studies, the KPMG study shows. The study, the first of its kind, was made in 2016.

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