Medical Research Act: Shorter review periods, new ethics committee starts

Berlin. The Medical Research Act (MFG), which improves the framework for the development, approval, and manufacture of pharmaceuticals and medical devices, will take another step toward implementation on July 1. The law was scheduled to enter into force on October 30, 2024.

First, new radiation protection regulations for medical research will come into force at the beginning of this month. The Radiation Protection Act, amended by the MFG, reduces bureaucratic hurdles for clinical studies involving radiation applications on humans, the Federal Office for Radiation Protection (BfS) announced on Monday.

This simplifies the approval process for scientists in many clinical trials. This applies, for example, when CT scans are used to test the efficacy of a new drug. Previously, in many cases, studies had to be reported to and reviewed by the Federal Office for Radiation Protection (BfS).

Examinations in radiation protection law are shortened

In the future, the use of radiation will be evaluated by the Ethics Committee, which is responsible for the overall ethical assessment of the study. The review process will be more efficient by eliminating the need for two separate bodies. However, studies such as those testing radiopharmaceuticals will continue to require approval from the Federal Office for Radiation Protection (BfS).

However, the Federal Office for Radiation Protection (BfS), the Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI), and the Ethics Committee now conduct parallel review of clinical trials. This would align the review periods under radiation protection law with those under pharmaceutical and medical device law. Scientists would only need to submit clinical trials to a central portal, reducing the bureaucratic burden.

With the establishment of the Specialized Ethics Committee, another key element of the Medical Devices Act (MFG) will be implemented on July 1. This body is intended to complement the existing ethics committees established under state law. It will be responsible, in particular, for highly complex procedures. The office of this independent committee is located at the Federal Institute for Drugs and Medical Devices (BfArM).

Lay people are also represented in the new commission

The Specialised Ethics Committee is responsible, among other things, for reviewing clinical trials in which new drugs are tested on humans for the first time, clinical trials in the context of advanced therapies (ATMPs), and studies that follow an overarching protocol – such as platform, basket or umbrella studies.

The interdisciplinary commission currently comprises 98 members, each with medical, legal, ethical, and statistical expertise, according to a statement from the BfArM on Monday. Laypersons are also represented. Anesthesiologist Dr. Ulrike Artmeier-Brandt was elected chair at the committee's first meeting. (fst)