There are large international differences in the authorization of new medicines, as regards the resources of the authorities, the speed of the approval processes and the costs for pharmaceutical companies. This is shown by a study by the European Center of Pharmaceutical Medicine of the University of Basel published by the journal Nature Reviews Drug Discovery.
In their study, researchers compared the authorities in 12 countries that are responsible for the authorization of medicines and medical devices, including Swissmedic in Switzerland and the US Food and Drug Administration (FDA). As the results show, internationally active pharmaceutical companies are finding very different regional requirements.
Depending on the country of approval, identical products are not only tested for efficacy and safety according to different standards and processes, but certain aspects are also examined and assessed in several different ways.
Harmonization could increase efficiency
The hurdles of admission (fees, preparation of studies, waiting time to market entry, etc.) are, as is known, a major factor in the development of drug development worldwide. Different licensing requirements extend the time to market approval of new, innovative medicines and increase their costs. To this extent, the study shows that harmonization of licensing requirements and processes could significantly increase efficiency.
“This would benefit patients in particular as new drugs would be available more quickly and at a lower cost,” commented Prof. Dr. Thomas D. Szucs from the European Center of Pharmaceutical Medicine at the University of Basel. “This is in favor of the fact that, alongside the manufacturers, the authorities should be more international and communicate with each other.”
With their study, the researchers hope to contribute to the cost-effectiveness of drug development and to reduce the duration of the approval process.
Filed Under: Drug Discovery
