Federal Institute for Drugs and Medical Devices
The Federal Institute for Drugs and Medical Devices (BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health (BMG) with the responsibility to ensure the safety of medicinal products and patients in Germany. The BfArM main tasks include licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors as well as research. Its legal basis is primarily the German Medicines Act (AMG), the Medical Devices Act (MPG), and Narcotic Drugs Act (BtMG).
Goal
The BfArM aims to ensure the safety of medicinal products and patients. as an important contribution to the prevention of health risks to citizens in Germany.
Areas of responsibility
Clinical trials
In order to test the health benefits, efficacy, safety, and pharmaceutical quality of medicinal products, the BfArM approves the performance of clinical trials.
Licensing
Based on the documents submitted by pharmaceutical companies and through on-site inspections, BfArM employees evaluate whether the medicinal product applied for has the required pharmaceutical quality, efficacy and safety. If the risk-benefit ratio is positive, marketing authorization is granted.
Monitoring of safety
After the approval of medicinal products, patients may experience adverse drug reactions that were not detected in the clinical studies required for the authorization. The BfArM collects and evaluates reports on adverse drug reactions (pharmacovigilance) and takes the necessary measures to protect patients.
Risk identification and evaluation of medical devices
The use of medical devices can entail risks. In order to keep these as low as possible for the population, the BfArM records, analyzes and evaluates the risks arising during use or application and coordinates the measures to be taken if necessary.
Monitoring of narcotics
The Federal Opium Agency is part of the BfArM and issues licenses for the legal marketing of narcotics and their components. It also monitors their production, cultivation, trade, import and export.
Research
Regulatory activities and research complement each other at the BfArM. In this context, BfArM’s research focuses on important and thematically current research priorities in connection with the marketing authorization and improvement of medicinal product safety as well as risk identification and assessment for medical devices. Various interdisciplinary researchers groups of BfArM work closely with leading national, European and international universities and non-university research institutions.
International
As Europe’s largest medicines regulatory authority, BfArM experts contribute their expertise to the scientific committees of the European Medicines Agency (EMA). In addition, BfArM is represented by the executive department „ European and International Affairs“ in various EU bodies, EMA working groups and other international scientific committees at EU and international level. Within the framework of the GHPP, BfArM is significantly involved in projects that strengthen medicinces regulatory authorities in partner countries.
Further information on the BfArM can be found here.
Facts
Projects
Strengthening Capacity and Infrastructure Building in Drug Quality Assurance in African countries: A Contribution by BfArM to WHO Standards and good Laboratory Practice
Building Regulatory Capacities and Infrastructure: Marketing Authorisation of Medicinal Products
Cross-Project Enquiry into e-LEARNing Concepts Towards Supporting Sustainable Capacity Building in the Context of GHPP
Regulatory Training and Advice in the Field of Pharmaceuticals