Admission procedure in Germany: deadlines are constantly exceeded!

Admission procedure in Germany: deadlines are constantly exceeded!

Deutschland - The drug approval in Germany is increasingly in the crossfire of criticism. Ärzteblatt Deadlines in the decentralized procedure are often exceeded. A central problem with this is inadequate documents from the pharmaceutical companies, which confirms an answer from the Federal Government to a request from the AfD. The legally intended 30 days for processing are "mostly" observed in Germany.

In the case of medicinal products with known active ingredients, such as generics, an EU member state has responsibility as a procedural state (Reference Member State, RMS). This develops an evaluation report (Assessment Report, AR), which is then accepted or contested by other member states. In practice, however, the picture is bleak; The average processing time in the area of ​​responsibility of the Paul-Ehrlich Institute (PEI) is 35 days, while the Federal Institute for Medicines and Medical Devices (BfArM) even needs an average of 188 days. This duration varies from 16 to astonishing 894 days.

causes and reforms

What is liable for the long processing times? According to the data recorded between 2020 and 2025, the causes are diverse. Mainly it is delayed translations of the product information and the often poor quality of the submitted documents. Certainly one reason that the Federal Government occurs for a reform of the EU drug law in order to start the period of 30 days only after high-quality translations.

diverse procedures for admission

The large number of admission procedures do not make things easier. In addition to the decentralized procedure, the national procedure and mutual recognition exists to name just a few. A central procedure on the part of the European Medicines Agency (EMA) is mandatory for new active ingredients for the treatment of serious diseases and for biotechnologically produced drugs. The authority, which is based in Amsterdam, checks the application documents and gives recommendations for admission.

drugs for rare suffering or those that are used especially in cancer and autoimmune research can also only be approved by this central path. Thus, there is sometimes a significant gap between innovative drugs and the legal reality.

Overall, it becomes clear that the reform requirement is urged and that it is time to tighten the processes for drug approval. The increased processing times, some of which increase to over 700 days, are in strong contrast to what patients and doctors expect: a quick and uncomplicated supply of vital medication

.

It seems that not only Germany faces the challenge, but also the entire European drug processing has to be put to the test. And it is still important to wait whether the measures taken will bring the hoped -for relief.