Drug approval harmonisation shows savings potential

Researchers have compared the regulatory authorities responsible for approving drugs and medical products in 12 countries, identical products were evaluated according to different standards and processes to verify their effectiveness and safety.

The results show that international pharmaceutical companies encounter very different regional requirements among them were Swissmedic in Switzerland and the U.S. Food and Drug Administration (FDA).

Harmonisation could increase efficiency

The regulatory hurdles for approval (fees, studies, evaluation periods) are known to be a significant time factor in the global drug development.  Different approval requirements prolong the time until the market entry of new, innovative drugs which also impacts their price.

The study shows that a harmonisation of these approval requirements and processes could significantly improve efficiency.

“Patients would profit especially since new drugs would be available faster and at lower prices,” comments Prof Thomas D Szucs from the European Centre of Pharmaceutical Medicine at the University of Basel. “This suggests that companies and authorities should strengthen their international collaboration and communicate better with each other.”

With their study, the researchers hope to contribute to higher cost efficiency in the development of drugs and shorter authorisation processes.