The Study Location Germany Initiative (ISD) is working

Habemus Medical Research Act (MFG). The new MFG came into force with its publication in the Federal Law Gazette on October 30, 2024.

On November 8, 2024, the experts from the Study Location Germany Initiative (ISD) met in Berlin for further consultations. The ISD includes AKEK (Medical Ethics Committee Working Group), BPI (Federal Association of the Pharmaceutical Industry), BÄK (Federal Medical Association), BUVEBA (Federal Association of Study Nurses//Study Assistants in Clinical Research e.V.), BVMA (Federal Association of Medical Contracting Institutes e.V.), BVMed (Federal Medical Technology Association), DHM (German University Medicine MFT and VUD), DGHO (German Society for Hematology and Medical Oncology e.V.), DGPharMed (German Society for Pharmaceutical Medicine e.V.), Fraunhofer Society, KKS Network e.V. (Coordination Centers for Clinical Studies), Leibnitz Association, NUM (University Medicine Network), VDGH (Association of the Diagnostic Industry e.V.) and VfA (Association Researching Drug Manufacturers e.V.).

The ISD is continuously committed to improving and simplifying the framework conditions for clinical studies in Germany as well as an overall efficient approval process. The core requirements are the optimal integration of radiation protection approval into the approval process at the BOBs, a strengthening of the system of registered ethics committees through harmonization and the introduction of standard contractual clauses.