Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from clinical trials, GMP issues for ATMPs up to pharmaceutical pricing and reimbursement (AMNOG) as well as administrative re-organizations of regulatory agencies and Ethics Committees.
This blog discusses the proposed changes for clinical trials with pharmaceuticals, medical devices and companion diagnostics…
