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Admission process in Germany: deadlines are constantly exceeded!
Germany often exceeds the 30-day deadline for drug approvals, which makes reforms in EU law necessary.
Admission process in Germany: deadlines are constantly exceeded!
Drug approval in Germany is increasingly coming under fire. Medical Journal reports that deadlines are often exceeded in the decentralized procedure. A central problem here is insufficient documentation from pharmaceutical companies, which is confirmed by a response from the federal government to a request from the AfD. The legally required 30 days for processing are “mostly” not adhered to in Germany.
For medicines with known active ingredients, such as generics, an EU member state has responsibility as the reference member state (RMS). This prepares an assessment report (AR), which is then accepted or challenged 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 Drugs and Medical Devices (BfArM) even needs an average of 188 days. This duration varies from 16 to a staggering 894 days.
Causes and reforms
What is responsible for the long processing times? The causes are varied, according to data collected between 2020 and 2025. The main reasons are delayed translations of product information and the often poor quality of the documents submitted. This is certainly a reason why the federal government is calling for a reform of EU pharmaceutical law so that the 30-day period only begins after high-quality translations.
In addition, restructuring measures were carried out in the BfArM aimed at improving the process management quality and accelerating the national phase. A new “slot system” is now intended to support applicants with reliable processing times and thus shorten the long waiting times.
Diverse approval procedures
The multitude of approval procedures does not make things any easier. In addition to the decentralized procedure, there is the national procedure and mutual recognition, to name just a few. The European Medicines Agency (EMA) requires a central procedure for new active ingredients to treat serious illnesses and for biotechnologically produced medicines. The authority, which is based in Amsterdam, examines the application documents and makes recommendations for approval.
Medicines for orphan diseases or those used specifically in cancer and autoimmune research can also only be approved via this central route. There is therefore sometimes a significant gap between innovative medicines and legal reality.
Overall, it is clear that there is an urgent need for reform and that it is time to streamline the drug approval processes. The increased processing times, some of which have increased to over 700 days, are in stark contrast to what patients and doctors expect: a quick and uncomplicated supply of vital medication
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It seems that not only Germany is facing the challenge, but also the entire European pharmaceutical processing system needs to be put to the test. And it still remains to be seen whether the measures taken will bring the hoped-for relief.