(Vienna, 01 July 2026) The Medical University of Vienna and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have signed a memorandum of understanding to deepen their cooperation in the field of regulatory science. The focus is on research, international staff exchanges and joint activities on biostatistical methods for regulatory decision-making processes.
MedUni Vienna and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) signed a Memorandum of Understanding on 30 June 2026. On behalf of MedUni Vienna, the agreement was signed by Rector Markus Müller, Michaela Fritz, Vice-Rector for Research and Innovation, Martin Posch, Head of the Center for Medical Data Science, and Franz König, Head of the Center for Medical Statistics. The aim of the Memorandum of Understanding is to facilitate collaboration in research and staff exchanges, to capitalise on the respective strengths of both institutions, and thereby to contribute to the further development of regulatory science.
Focus on biostatistics and clinical trials
A key focus of the cooperation is the collaboration between the Center for Medical Data Science at MedUni Vienna and the biostatistics group at the PMDA’s Centre for Product Evaluation. Plans include international staff exchanges and joint cross-border activities. In terms of content, the focus is particularly on the further development of statistical methods relevant to regulatory decision-making processes in drug development.
MedUni Vienna brings to the collaboration its expertise in medical statistics, innovative clinical trial design and data science methods. At the same time, the collaboration aims to further expand MedUni Vienna’s international network in the field of regulatory science.
Contribution to staff development in regulatory science
For the PMDA, this collaboration forms part of its ‘Alliance for Regulatory Science Advancement’ (ARSA) initiative. As part of this initiative, the PMDA cooperates with academic and scientific institutions worldwide to promote practice-oriented training, joint activities and the education of the next generation of professionals in the field of regulatory science.
Through collaboration with internationally active scientists, PMDA staff aim to deepen their existing specialist knowledge, gain practical experience with modern analytical methods and further develop their understanding of current research findings. The insights gained from the collaboration are also intended to be incorporated into the PMDA’s internal processes and to further strengthen scientifically sound approaches to authorisation assessments and safety measures.
The collaboration is thus intended to contribute both to the further development of regulatory expertise and to the establishment of international professional networks.