MedUni Vienna and the PMDA strengthen their collaboration in regulatory science
The Medical University of Vienna and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have signed a Memorandum of Understanding to strengthen their collaboration in regulatory science, with a particular focus on biostatistics, clinical trial methodology and international staff exchange.
The agreement was signed on 30 June 2026 by MedUni Vienna Rector Markus Müller together with Vice-Rector for Research and Innovation Michaela Fritz, Martin Posch, Head of the Center for Medical Data Science and the Institute of Medical Statistics, and Franz König, Head of the Adaptive Designs Working Group. Representing the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) was Chief Executive Yasuhiro Fujiwara.
The collaboration aims to promote joint research activities, facilitate international staff exchanges and combine the complementary expertise of both institutions to advance regulatory science. A central focus is the cooperation between MedUni Vienna’s Center for Medical Data Science and the biostatistics group within the PMDA’s Centre for Product Evaluation.
Research activities will focus on the development of statistical methods that support regulatory decision-making in drug development. MedUni Vienna contributes expertise in medical statistics, innovative clinical trial design and data science while further strengthening its international network in regulatory science.
For the PMDA, the agreement forms part of its Alliance for Regulatory Science Advancement (ARSA), an international initiative promoting collaboration with leading academic institutions. Through the partnership, PMDA staff will gain practical experience with advanced analytical methods and strengthen scientific expertise that can be incorporated into regulatory assessments and safety evaluations.
Both institutions expect the collaboration to contribute to the further development of regulatory expertise while expanding international scientific networks in the field of regulatory science.