Bfarm

Acronym for Federal Institute for Drugs and Medical Devices. The Federal Institute for Drugs and Medical Devices, BfArM for short, is an independent higher federal authority (BOB) within the area of responsibility of the Federal Ministry of Health and serves to avert health hazards. The special tasks of the BfArM are the approval and registration of drugs - especially the approval of finished drugs and generics -, the risk monitoring of drugs (pharmacovigilance), the monitoring of the traffic in narcotics and basic substances as well as the recording and evaluation of hazards associated with medical devices. Furthermore, the BfArM is responsible for the registration or approval of homeopathic drugs, anthroposophics and phytopharmaceuticals.

On 24 June 1994, the Federal Institute for Drugs and Medical Devices was assigned the functions of the previously responsible Institute for Drugs. The Institute for Drugs was part of the Federal Health Office (BGA), which was dissolved on 24.06.1994 after all tasks had been transferred to the BfArM.

The BfArM has its headquarters in Bonn and is divided into 9 departments, which are divided into Licensing, Research, Scientific Service, Pharmacovigilance, Federal Opium Agency and Medical Devices.

The Federal Institute for Drugs and Medical Devices plays an important role in clinical studies. Before starting a clinical study, approval must be obtained from the BfArM. An exception to this is clinical studies involving vaccines and biomedical drugs, for which the Paul Ehrlich Institute (PEI) is responsible. In clinical studies, proof of efficacy, safety and adequate pharmaceutical quality must be provided. Clinical studies are an essential basis for the approval of finished medicinal products, so that the studies are also subject to numerous monitoring and checks before their results are used for the evaluation for the approval of medicinal products.

The application for approval of the clinical study to the BfArM must be submitted in writing. The approval by the higher federal authority is usually granted within 30 days.