The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), Federal Institute for Vaccines and Biomedical Products, are responsible at national and European level for,

• the efficacy,
• quality and
• safety

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 drugs, namely.

• Immunoglobulins,
• monoclonal antibodies,
• blood, bone marrow, tissue preparations,
• allergens,
• test sera,
• test antigens,
• gene transfer drugs,
• somatic cell therapeutics,
• xenogeneic cell therapeutics, and
• genetically engineered blood components.

All other medicinal products for human use fall under the responsibility of the BfArM. The necessary documents for approval are submitted by the pharmaceutical entrepreneur who wishes to place the drug on the market.

The BfArM or PEI can therefore provide you with the following information:

• the receipt of an application for marketing authorization 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 drug 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.

Notice:
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:
    • Implants,
    • dressing materials,
    • medical software,
    • medical instruments,
    • dental products
  • Examples in the PEI area of responsibility:
    • 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 registers
• Healthcare data
• Education and access to health care professions