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New radiation protection rules from July: This makes research easier!
From July 1, 2025, new, simplified radiation protection rules for clinical studies in Germany will come into force in order to promote research.
New radiation protection rules from July: This makes research easier!
From July 1, 2025, medical research in Germany will be significantly relieved by new radiation protection rules. The Medical Research Act (MFG), which was passed in autumn 2022, aims to reduce bureaucratic hurdles and improve the framework conditions for clinical studies. This was announced by the Federal Office for Radiation Protection (BfS). The focus is on ensuring an innovation-friendly environment while maintaining a consistently high level of patient safety. This will make it easier for many clinical trials to be approved, particularly for studies that use computed tomography (CT) scans to test new medications.
As the Ärzteblatt reports, the entire approval process for radiation protection applications is being redesigned. Previously, there were two separate procedures for reporting accompanying radiological diagnostics and approving new therapeutic procedures. These outdated practices have complicated application processing. With the new guidelines, it is now possible for notification procedures to no longer be submitted to the BfS, but to the specialized ethics committee at the Federal Institute for Drugs and Medical Devices (BfArM). This change allows for more efficient processing and faster approvals.
Less effort, faster approvals
From July, the processing process will be simplified: the approval period for radiation protection applications will be shortened from 132 to 106 days, while requests for changes will in future be processed within 60 days. According to information from the Paul Ehrlich Institute, applications for clinical trials with drugs and medical devices that use radiation are submitted centrally via the new systems, the Clinical Trials Information System (CTIS) for drugs and the German Medical Device Information and Database System (DMIDS) for medical devices.
The change in procedures also benefits the researchers. Markus Schmitt from the BfS explained that the new central submission portal – the so-called “Single Gate” – allows them to significantly reduce administrative effort. “This is a big step in the right direction,” said Schmitt. Applications for procedures involving radiation, such as the use of radioactive substances, must be clearly stated in the cover letter and accompanied by the necessary documents. In addition, there is no need for separate notification to the BfS.
Patient protection remains a priority
Despite the simplified regulations, patient protection remains a key priority. The approval criteria remain unchanged: All procedures must be designed in such a way that the radiation exposure for the participants is as low as possible. This ensures that the safety of the participants is not jeopardized even with faster approval. BfS President Inge Paulini emphasizes that radiation protection is essential for both patient safety and the acceptance of innovative procedures.
From July 1st, the BfS will put the new regulations into practice. Some of the existing resources will be used to concentrate on more complex approval procedures and to expand advisory services for applicants. This new system for clinical studies relies on close collaboration with professional societies and promotes exchange between all those involved. Research in the field of medicine should therefore be further supported, which could also have positive effects on Germany as a research location.
For more information, you can find the complete details about the new regulations on the pages of Ärzteblatt, des Paul Ehrlich Institute and the [Federal Office for Radiation Protection](https://www.bfs.de/SharedDocs/Press Releases/BfS/DE/2025/009.html).