Implementation by BfArM and Paul-Ehrlich-Institut
Source: ipopba/iStock
The Medical Research Act (Medizinforschungsgesetz, MFG) came into force on 30 October 2024. The aim of the law is to increase Germany's attractiveness as a location for innovative medical research. More specifically, the MFG will improve the legal framework for conducting clinical trials, simplify bureaucratic processes and approval procedures for clinical trials and authorisation procedures, and facilitate access to research data.
Germany plays a significant role in the research and development of medicinal products. After Spain, Germany hosts the most multicentre clinical trials that are carried out in Europe, which underpins its prominent position as an important location for development and production. At the same time, medicinal product development and medical technology are experiencing rapid changes. The faster development cycles of medicinal products require close cooperation between research institutes, companies, and authorities.
This is where the MFG comes in to support the development of Germany as a future-oriented pharmaceutical location. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, play a central role in this process. Together, the two German medicines authorities offer comprehensive advice to applicants. The Paul-Ehrlich-Institut and the BfArM with their complementary product responsibilities support each other and work together to further accelerate regulatory procedures for applicants.
The two higher federal authorities see themselves as enablers and drivers of modern healthcare. These roles involve increased cooperation, in particular through the central coordination and procedural management of authorisation procedures, scientific advice, and applications for clinical trials from the BfArM. The common goal is to be able to process procedures faster.
Both higher federal authorities are active within the following central areas of action:
The two institutions use their internal assessment expertise to leverage synergies together. Their cooperation is carried out in compliance with content and product-specific responsibilities and the recognised technical competencies of both authorities.
The Specialised Ethics Committee for Special Procedures, i.e. particularly complex or urgent procedures, has been set up at the BfArM in accordance with section 41c of the Medicinal Products Act (AMG).
Specialised Ethics Committee (German only)
Radiation protection notification and approval procedures are integrated into the clinical trial approval procedures, so separate application submissions to different authorities are no longer required. This reduces costs and time expenditures.
At the BfArM, a central coordination office has been set up for both institutes with the aim of coordinating and harmonising cooperation between the two higher federal authorities in the areas of scientific advice, medicinal product authorisation procedures, and approval of clinical trials.
The institutes shall simplify and accelerate the approval procedures for mononational clinical trials.
Clinical Trial – approval procedure
Any objections to be raised against a decision issued by the BfArM or Paul-Ehrlich-Institut can also be submitted electronically via the joint objection portal as of 24 February 2025.
Source: BfArM/Jörn Wolter
"The Medical Research Act is a crucial step in advancing medical research and strengthening Germany as an attractive location. As higher federal authorities, we clearly see ourselves as enablers and drivers. We are working together to make the application experience more efficient and thus create good conditions for innovative medical research."
Source: T.Jansen/Paul-Ehrlich-Institut
"As higher federal authorities with different product responsibilities and expertise – the BfArM for chemical medicinal products and the Paul-Ehrlich-Institut for vaccines and biomedicines – we complement each other within the framework of the Medical Research Act, support each other, and benefit from synergy effects. Pharmaceutical companies and academic drug developers benefit from our cooperation by having centralised access to specialised scientific advice, efficient approval procedures for clinical trials, and optimised authorisation channels. The close cooperation between our pharmaceutical institutes creates reliable conditions for innovative medicinal product developments and strengthens Germany's position in the pharmaceutical sector."
The Paul-Ehrlich-Institut and the BfArM will intensively evaluate the realisation and implementation of the measures described above in terms of how they contribute to making Germany an attractive research and development location. Both higher federal authorities are also working to continuously improve their close cooperation in order to leverage further synergy potential.
Updated: 16.04.2025
