Federal Institute for Drugs and Medical Devices (BfArM)
The Federal Institute for Drugs and Medical Devices is an independent specialised federal higher authority within the portfolio of the Federal Ministry of Health.
Roughly 1,000 employees – including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants and administrative staff – work at the Federal Institute for Drugs and Medical Devices and authorising new products and improving the safety of drugs, registring and assessing the risks of medical devices and monitoring trade in narcotic drugs and precursors. The Federal Institute for Drugs and Medical Devices thus makes an important contribution to protecting the population against health risks.
Authorisation and Registration of Drugs
A focus of the work of the Federal Institute for Drugs and Medical Devices is the authorisation of proprietary medicinal products according to the provisions of the Medicinal Products Act. In this conjunction, the health benefit, i.e., the effectiveness, the safety and the pharmaceutical quality are assessed. In addition, the Federal Institute for Drugs and Medical Devices fulfils important tasks within the framework of European drug authorisation.
Homeopathic drugs are either registered by the Federal Institute for Drugs and Medical Devices without any information regarding possible applications or authorised for specific applications.
Medicinal Product Safety (pharmacovigilance)
After medicinal products have been used by numerous patients subsequent to authorisation, adverse effects that may not have been evident in previous testing during the course of the clinical trials mandated for the authorisation process can manifest themselves. The Federal Institute for Drugs and Medical Devices collects and assesses reports on the adverse effects of medicinal products and takes the necessary steps to protect patients.
Registering and Assessing Risks Related to Medical Devices
Medical devices are instruments, apparatus, appliances, software, substances and preparations made from substances and other objects for medical purposes intended by their manufacturers for human use, e.g., x-ray machines, cardiac pacemakers, artificial hip replacements, bandages, infusion equipment, catheters, optical aids, condoms, medical instruments and laboratory diagnostics.
The main tasks of the Federal Institute for Drugs and Medical Devices involve the central collection, analysis and assessment of risks resulting from the application or use of medical devices and in coordinating any measures that must be taken. In this conjunction, it relies on the reports it receives regarding incidents with medicinal products.
Narcotics and Precursors
The Federal Opium Agency, which is responsible for granting licenses to legally trade in narcotic drugs and precursors (i.e., for the production of substances suited for use as narcotics) as well as for overseeing their production, cultivation and sale as imports as well as exports is also part of the Federal Institute for Drugs and Medical Devices. It cooperates with international institutions to monitor trade in narcotics.