What you should be aware of in advance and common deficiencies. First of all, familiarise yourself thoroughly with the legal basis! This is your most important tool. We have summarised it for you in a …

It bundles all advice procedures offered by BfArM and Paul-Ehrlich-Institut on a central platform. Since February 13, 2025, the public part of the federal medicinal product database has been fully available …

Jun 3, 2024 · For detailed information on CTIS, the BfArM provides a FAQ-page in English: BfArM-CTIS. As might be expected, there are a number of initial problems with the implementation of the new …

The GCP Inspections Unit is responsible for questions regarding compliance with the regulatory requirements of clinical trials in procedures of the BfArM and procedures of the European Medicines …

Scientific Advice allows a more in-depth discussion of specific questions regarding national applications and marketing authorisation procedures for medicinal products that are within the remit of the BfArM.

Scientific Advice allows a more in-depth discussion of specific questions regarding national applications and marketing authorisation procedures for medicinal products that are within the remit of the Paul …

The Federal Institute for Drugs and Medical Devices (BfArM) provides an overview of current supply shortages for human medicinal products (excluding vaccines) in Germany.

The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency (EMA), among others.

The joint database of BfArM and Paul-Ehrlich-Institut (PEI) offers the option of digital reporting of adverse drug reactions for healthcare professionals and patients.

Bekanntmachung zur klinischen Prüfung von Arzneimitteln am Menschen Gemeinsame Bekanntmachung des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich …