5. The institutions
Various institutions and authorities are involved in the approval and benefit assessment of drugs. These are the most important national and international ones:
Federal Institute for Drugs and Medical Devices (BfArM)
BfArM's responsibilities include the approval of drugs for the treatment of humans as well as of homeopathic and traditional herbal drugs (“particular therapeutic systems”). BfArM also monitors the safety of drugs and medical devices.
Since 2020, BfArM has also been evaluating some of the digital health applications of the low-risk classes I and IIa, and deciding on their inclusion in the catalogue of health services covered by the statutory health insurance (SHI) funds.
BfArM is located in Bonn, Germany. bfarm.de
Paul Ehrlich Institute (PEI)
The PEI is responsible for the approval of vaccines, sera, blood preparations, tissues and tissue preparations, allergens, advanced therapy medicinal products (gene therapeutics, somatic cell therapeutics, and biotechnologically manipulated tissue products), xenogeneic medicinal products (consisting of living animal tissues or cells), and genetically engineered blood components.
The PEI is located in Langen near Frankfurt am Main, Germany. pei.de
Federal Joint Committee (G-BA)
The G-BA is the highest decision-making body of the joint self-governing German health care system. Self-government includes the associations of SHI funds and service providers at the state and federal level. The respective bodies at the federal level, i.e. the National Association of Health Insurance Funds ( GKV-Spitzenverband), the National Associations of SHI Physicians and Dentists (KBV, KZBV), and the German Hospital Federation (DKG) jointly develop solutions in the G-BA and make binding decisions for the SHI system.
This includes, for example, which health care services are covered by the SHI funds. During an early benefit assessment, the G-BA decides on the added benefit of the new drug on the basis of IQWiG's report. The GKV-Spitzenverband and the pharmaceutical company then negotiate the extent to which the SHI funds will cover the cost of the new drug.
Patient organizations also participate in the G-BA. They provide advice and have the right to submit proposals, but no voting rights.
Institute for Quality and Efficiency in Health Care (IQWiG)
The Institute for Quality and Efficiency in Health Care (IQWiG) examines the benefits and harms of health care services for patients. To this end, it prepares independent, evidence-based reports (e.g. on behalf of the G-BA as part of an early benefit assessment). IQWiG itself does not decide on SHI coverage for drugs or other health care services.
IQWiG is located in Cologne. iqwig.de
European Medicines Agency (EMA)
The EMA is located in Amsterdam, The Netherlands. ema.europa.eu
Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is the regulatory authority of the United States for food, drugs and other products. Its responsibilities include the scientific evaluation, approval and safety monitoring of drugs and medical devices. The FDA reports to the US Department of Health and Human Services.
The FDA is located in Silver Spring, Maryland, USA. fda.gov