The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), Federal Institute for Vaccines and Biomedical Products, are responsible for this at national and European level,
- the efficacy,
- quality and
of new medicinal products for use in humans and for immunological veterinary medicinal products and to approve them.
The PEI is responsible for vaccines and biomedical medicinal products, namely.
- monoclonal antibodies,
- blood, bone marrow, tissue preparations,
- test sera,
- test antigens,
- gene transfer drugs,
- somatic cell therapeutics,
- xenogenic cellular therapeutics, and
- genetically engineered blood components.
All other medicinal products for human use fall under the responsibility of the BfArM. The necessary documents for marketing authorisation are submitted by the pharmaceutical entrepreneur who wishes to place the medicinal product on the market.
The BfArM or PEI can therefore provide you with the following information:
- the receipt of an application for marketing authorisation of a medicinal product (the overview, which is updated once a month, can be found on the BfArM homepage),
- the receipt of an application for approval of a clinical trial to confirm the quality, efficacy and safety of a medicinal product in a group of patients, and
- the approval or rejection of a clinical trial intended to confirm the quality, efficacy and safety of a medicinal product in a group of patients.
The BfArM or the PEI can also provide you with further information on the following topics:
- Drug safety
- Medical devices for use in humans;
- Examples in the area of responsibility of BfArM:
- dressing materials,
- medical software,
- medical instruments,
- dental products
- Examples in the area of responsibility PEI:
- In vitro diagnostics for testing for high-risk pathogens such as HIV/AIDS, hepatitis, ZIKA or for determining blood groups
- Reagents and reagent products
- Medical classifications
- Health care registries
- Healthcare data
- Training and access to health care professions