Germany’s Medical Research Act is almost two years old. Writing in the June/July 2026 edition of DIA Global Forum, Thomas Sudhop, Claudia Riedel and Karl Broich of the Federal Institute for Drugs and Medical Devices (BfArM) outline how the Act attempts to revitalise clinical research in Germany, balancing faster procedures with high safety standards, and its implications for trial sponsors.
With the Medical Research Act (Medizinforschungsgesetz, MFG), Germany is not merely shortening administrative timelines; it is repositioning its regulatory ecosystem as an active enabler of clinical development. By combining early regulatory dialogue, central coordination between BfArM and Paul-Ehrlich-Institut (PEI), harmonized ethics review, integrated radiation-protection procedures, and more predictable contracting, Germany is creating a clearer pathway from scientific idea to first patient access. This article details these changes and how they will support medical product developers in Germany in the future. The challenge for this Act was to strike a balance between streamlining procedures and maintaining high safety standards.
Focus of the MFG
The MFG came into force on 30 October 2024. It was developed within the context of the federal government’s pharmaceutical strategy. The legislative process was characterized by broad engagement of relevant stakeholders from the pharmaceutical industry, academic research, clinical trial centers, and the two federal national competent authorities (NCAs), the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul‑Ehrlich‑Institute, which contributed their perspectives through a series of consultation processes.
The primary focus of the MFG is on shortening the time to trial initiation and thereby increasing the number of clinical trials in Germany. More efficient and standardized approval procedures and faster contract negotiations between trial sites and sponsors should significantly reduce the time between application submission and the initiation of clinical trials.
Ultimately, the MFG aims to increase efficiency in administration and regulation. Through digitalization, standardization, and clearer structures of responsibility, resources on the part of authorities, ethics committees, and applicants are to be better utilized.
Measures to Shorten Time to Trial Initiation
For mono‑national clinical trials, no coordinated review with other EU Member States is required, as the substantive assessment—covering both Part I of the assessment report, carried out jointly by the relevant NCA (either the BfArM or the PEI, depending on the product) and the respective ethics committee; and Part II, assessed solely by the competent ethics committee—is conducted entirely at the national level. Nevertheless, longer processing times were observed in the past, as the EU Clinical Trials Regulation (CTR) does not provide for adjusted timelines for mono‑national clinical trials. The MFG addressed this issue at the national level by shortening the substantive review period by 19 days to 26 days and enshrining this new deadline in the German Medicines Act. Although the law does not extend this reduction to include substantial modifications to approved clinical trials, both the German Working Group of Medical Ethics Committees (AKEK) (German text only) and the two NCAs have implemented a similar reduction in these procedures through a voluntary self-commitment.
In addition to the sometimes lengthy approval periods, analyses by industry associations showed that the lengthy contract negotiations between sponsors and individual trial sites in Germany took significantly longer than in comparable Member States. This was addressed by the authorization of a national ordinance to establish standard contractual clauses for such contracts. This new ordinance provides for pre-formulated standard clauses for contracts between the parties, unless both parties mutually agree to deviate from any of these clauses.
Harmonizing the Work of Ethics Committees
Although the AKEK has been attempting for years to harmonize the working methods of the ethics committees involved in clinical trial review in Germany, this effort has been only partially successful, as the AKEK previously lacked the authority to issue guidelines with the necessary binding force. This was corrected by the MFG, and the AKEK was granted the authority to issue and publish such guidelines, which should be followed by all ethics committees assessing clinical trial applications in Germany.
