Strengthening research and medical production in Germany: The new Medical Research Act
A contribution by Prof. Dr. Zoltán Ivics, PhD, DSc, MAE (Designated President of the German Society for Gene Therapy e.V.)
The Paul-Ehrlich-Institut (PEI) is the Federal Institute for Vaccines and Biomedicines within the portfolio (department) of the Federal Ministry of Health. As a pharmaceutical authority, it is responsible for human and veterinary vaccines, immunological veterinary medicinal products and all biomedicinal products for human use, including gene and cell therapies. In order to further enhance the attractiveness of Germany as a pharmaceutical location, the German government is committed to improving the framework conditions for a sustainable and internationally competitive pharmaceutical industry in Germany and the European Union. Among other instruments, an interdisciplinary Federal Ethics Commission will be established at the Federal Institute for Drugs and Medical Devices (BfArM). In addition, the BfArM will be responsible for the coordination and process management of approval procedures and applications for clinical trials for medicinal products, including gene and cell therapies. Among other measures, the processing times for mononational clinical trials will be shortened. This means that the regulatory procedures (including scientific advice and the approval of clinical trials) will be centrally coordinated by the BfArM as a "single entry point", but the actual responsibilities will remain at the institutions where the necessary expertise is available. Gene and cell therapies will continue to be regulated by the PEI. Altogether, the new regulations should simplify and accelerate the approval of studies and reduce bureaucracy.
Please find an overview of the new law on the website of the Federal Ministry of Health here (German only).