My watch list
my.bionity.com  
Login  

Drug Approval: New Country Comparison Shows Great Savings Potential

15-Aug-2017

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 results were published in the journal Nature Reviews Drug Discovery.

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.  Different approval requirements prolong the time until the market entry of new, innovative drugs which also impacts their price. The study thus shows that a harmonization 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. Dr. Thomas D. Szucs from the European Center 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 authorization processes.

Facts, background information, dossiers
More about Universität Basel
  • News

    How Caries-Causing Bacteria Can Survive in Dental Plaque

    Extracellular polysaccharides play a central role in the survival capabilities of caries-causing bacteria in dental plaque, report researchers from the University of Basel’s Preventative Dentistry and Oral Microbiology Clinic and Department of Biomedical Engineering in the journal Plos One. ... more

    Bacteria Have a Sense of Touch

    Although bacteria have no sensory organs in the classical sense, they are still masters in perceiving their environment. A research group at the University of Basel’s Biozentrum has now discovered that bacteria not only respond to chemical signals, but also possess a sense of touch. In thei ... more

    Newly Discovered microRNA Regulates Mobility of Tumor Cells

    Cancer cells can reactivate a cellular process that is an essential part of embryonic development. This allows them to leave the primary tumor, penetrate the surrounding tissue and form metastases in peripheral organs. In the journal Nature Communications, researchers from the University of ... more

  • Videos

    Virtual Reality in Medicine: New Opportunities for Diagnostics and Surgical Planning

    Before an operation, surgeons have to obtain the most precise image possible of the anatomical structures of the part of the body undergoing surgery. University of Basel researchers have now developed a technology that uses computed tomography data to generate a three-dimensional image in r ... more

    Nuclear Pores Captured on Film

    Zooming into a nuclear pore complex using a high-speed atomic force microscope reveals the selectivity barrier that filters the traffic of molecules passing between the cytoplasm and nucleus in eukaryotic cells. This is comprised of intrinsically disordered proteins known as FG Nucleoporins ... more

  • Universities

    Universität Basel

    Tradition - The city of Basel is home to the oldest university in Switzerland. Founded upon the initiative of local citizens in 1460, the University of Basel is a modern and attractive centre of teaching, learning, and research situated in the heart of the historic old town. Self - managed ... more

Your browser is not current. Microsoft Internet Explorer 6.0 does not support some functions on Chemie.DE