Medical Research Act – anything for genetic engineering work?

The Medical Research Act (MFG) is intended to simplify, among other things, the approval procedures for clinical trials and regulatory approval procedures and regulates the cooperation between research institutes, companies and authorities, in particular the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), the Federal Institute for Vaccines and Biomedicines. The BfArM will establish a specialized ethics committee, and radiation protection notification and approval procedures will be integrated into the approval process for clinical trials. The institutes will simplify and accelerate the approval procedures for mononational clinical trials. Furthermore, a joint objection portal created at the BfArM. The MFG is a statutory instrument that amends the Medicines Act (AMG), the Medical Devices Implementation Act, and the Radiation Protection Act.

If you search for the term “genetic engineering” (or similar), you will unfortunately not find anything, although the procedure also called for simplifications for genetic engineering.