BfArM Prepares for the Future

摘要

The organisation and procedures of BfArM, Germany's federal institute for drugs and medical devices, have been restructured and streamlined following an evaluation of the agency's performance. This was in response to frequent complaints by the pharmaceutical industry concerning the time taken by Bf ArM to process applications for national marketing authorisations. Those involved in the evaluation included Bf ArM staff, representatives of industry, members of the then federal ministry of health (BMG), sister agencies (such as the Paul-Ehrlich Institute, the German competent authority for blood products and vaccines, and DIMDI, the German institute of medical documentation and information) and a group of external consultants.