Drug Approval: New Country Comparison Shows Great Savings Potential

The regulatory requirements for the approval of new drugs vary greatly internationally in regards to the resources allocated to the authorities, the evaluation periods for approval and the fees for the pharmaceutical companies. This reports a study of the European Center of Pharmaceutical Medicine at the University of Basel. The researchers compared the regulatory authorities responsible for approving drugs and medical products in 12 countries, among them, for example, Swissmedic in Switzerland and the U.S. Food and Drug Administration (FDA). The results show that international pharmaceutical companies encounter very different regional requirements. Depending on the country, identical products are being evaluated not only according to different standards and processes to verify their effectiveness and safety, but certain aspects are also being reviewed and assessed multiple times and in various ways. Harmonization could increase efficiency. The regulatory hurdles for approval (fees, studies, evaluation periods, etc.) are known to be a significant time factor in the global drug development.