ith 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.

Specialized Ethics Committee for Special Procedures

For clinical trials requiring special expertise, the MFG additionally established a separate “Specialised Ethics Committee for Special Procedures” organized under federal law. This committee, whose secretariat was established at the BfArM, is composed of external scientists from various disciplines and evaluates the following clinical trials: first-in-human clinical trials, clinical trials involving advanced therapy medicinal products (ATMPs), clinical trials following complex master protocols, and clinical trials that have received scientific advice from the Emergency Task Force of the European Medicines Agency.

The registered ethics committees of the German States (Länder) may issue a special joint schedule of responsibilities for them for specific procedures requiring particular medical expertise (for example, clinical trials with minors as participants), in addition to the general joint schedule of responsibilities for the other registered ethics committees of the Länder.

Radiation Protection in Clinical Trials

Another Germany-specific issue in clinical trials involving the research‑related use of ionizing radiation was the insufficient integration of the clinical trial assessment with the additional radiation protection assessment. This sometimes led to duplicate reviews and, because the Federal Office for Radiation Protection (BfS) had to be involved in all procedures with its own submission and approval processes, it was very time‑consuming and often caused significant delays to the start of studies.

The MFG simplified the processes both for the notification procedure—which applies to most clinical trials and no longer requires the involvement of the BfS—and for the approval procedure with the BfS, which remains necessary for certain uses of radiation. Both procedures now require the submission of documents in parallel with the submission of the actual clinical trial application via the CTIS portal. For clinical trials subject to the radiation notification procedure, the radiation protection assessment is integrated into the scientific review of the clinical trial application, does not prolong the procedure, and is carried out exclusively by the concerned ethics committee. For clinical trials requiring a radiation protection approval procedure with the BfS, the approval procedure assessment timelines have been aligned with the CTR deadlines so that, as a rule, the start of the study is not delayed by this additional procedure either.

Single-Gate Approach for German NCAs

In addition to these fundamental adjustments to processes and responsibilities, the MFG optimized various other aspects of clinical trials and regulatory cooperation between the two national NCAs. In addition to increasing the flexibility of the two NCAs’ jurisdictions, a coordination office was established at the BfArM to coordinate all processes related to scientific advice, clinical trials, and licensing of medicinal products for both NCAs. This single-gate approach ensures that all applications and inquiries regarding these matters are processed through a single point of contact, eliminating the need for sponsors and pharmaceutical companies to conduct complex jurisdictional checks.

Clinical Trials Investigating Medicinal Products and in vitro Diagnostic Medical Devices

Although combined clinical trials involving medicinal products and in vitro diagnostic medical devices are becoming increasingly common in the context of personalized medicine, the legal approval procedures are not harmonized at either the European or national level and sometimes result in differing jurisdictions among ethics committees. The MFG has at least clarified at the national level that the ethics committee responsible for the CTR authorization procedure together with the NCA is also responsible for the required authorization procedure under medical device law, to avoid overlapping responsibilities between ethics committees.

Further Simplifications

In addition to the above changes, the MFG has introduced various other simplifications in the practical conduct of clinical trials. For instance, the national requirements for the labeling of investigational and auxiliary medicinal products have been simplified and now permit the use of English labeling in many cases, provided these products are not directly provided to trial participants (in which case the labeling must be in German). Furthermore, the distribution channel for investigational and auxiliary products for clinical trials with decentralized elements has now been legally adapted to allow for direct delivery to trial participants in their home environment.

Early Dialogue and Innovation Support

Beyond formal authorization procedures, Germany offers early dialogue formats that help innovators navigate regulatory expectations before pivotal procedural decisions are taken. The BfArM Innovation Office supports orientation meetings and advice for digital health applications, while the PEI Innovation Office has long supported early development of advanced and complex medicinal products, including ATMPs. Together with the central advice application portal introduced by BfArM and PEI, these formats strengthen Germany’s role as a regulatory partner for academic groups, startups, and pharmaceutical developers at an early stage of product development.

Enabling Clinical Development and Early Access to Innovation in Germany

This initiative was driven by the decline in Germany’s attractiveness for conducting clinical trials, a trend observed for years, particularly when compared to countries with more efficient regulatory processes and more centralized structures. The MFG marks a strategic step in strengthening Germany’s role as a predictable, science-driven, patient-oriented location for clinical research. In an increasingly competitive European clinical trial landscape, sponsors choose trial locations based on speed, predictability, regulatory clarity, and the ability to activate studies efficiently. The MFG addresses these factors through a coherent set of measures designed to make clinical research in Germany faster, more coordinated, and more attractive for both commercial and academic sponsors.

Rather than merely responding to past procedural complexity, the reform establishes a more enabling framework for clinical development. More centralized procedures, harmonized ethics review, standardized contractual elements, and clearer regulatory interfaces are intended to reduce avoidable administrative burdens and increase planning certainty for sponsors, investigators, and trial sites.

This enabling approach is further strengthened by early regulatory dialogue and innovation support. The innovation offices at BfArM and PEI provide an important entry point for developers seeking early orientation on regulatory expectations, procedural pathways, and authority responsibilities, particularly in the case of novel technologies, complex products, digital health applications, ATMPs, and other innovative development programs. These formats are especially valuable for academic research groups, biotech companies, and startups that may not have extensive in-house regulatory infrastructures.

By combining early scientific and regulatory interaction with coordinated assessment procedures and practical simplification measures, Germany can position itself not only as a country addressing previous inefficiencies, but as an active enabler of high-quality clinical development. If implemented consistently, the MFG can contribute to earlier patient access to innovation while reinforcing Germany’s role as a leading clinical research and innovation hub in Europe.

Where We Are Today: Implementation Ongoing

The MFG should be understood as more than a legislative package to reduce timelines. It establishes an enabling architecture for clinical development in Germany: early regulatory dialogue, central coordination, specialized ethics expertise, integrated interfaces for radiation protection and combined studies, predictable contracting, and incentives for local evidence generation. Its success will ultimately depend on implementation discipline, transparent performance metrics (yet to be determined), and the willingness of developers, academic sponsors, and trial sites to use the new pathways. If implemented consistently, the MFG can reposition Germany as a predictable, science-driven, patient-oriented location for clinical research in Europe.

As the law only came into force on 30 October 2024, most of its measures are still in early implementation. The new reimbursement incentives for drugs with ≥5% German study participation have been active since January 2025, while the 28-day approval deadline for mono-national clinical trials was one of the first steps implemented. Initial analyses indicate that the time to trial initiation has already been reduced and that the number of clinical trials in Germany has increased by approximately 6% in 2025 compared to 2024.

The overall impact will only become quantifiable during the coming years. It is now up to developers to embark on clinical trials in Germany and test the new ways of working. And there is more to come: Further changes in the German regulatory environment are expected through the implementation of the General Pharma Legislation once it is adopted. In December 2025, the European Parliament and the Council of the EU reached an agreement on the reform of the EU pharmaceutical legislation. During the transition period from 2026 to 2028, Member States will be required to adapt their national legal frameworks accordingly. The new pharmaceutical legislation is expected to apply from 2028 onwards.

To bridge the gap until the faster procedures under the EU Biotech Act are implemented, Germany is actively participating in the FAST-EU initiative to speed up the authorization of multinational clinical trials.