Bundesinstitut für Arzneimittel und Medizinprodukte

Section 77 of the Arzneimittelgesetz makes the Bundesinstitut für Arzneimittel und Medizinprodukte the competent federal higher authority for medicinal products unless the Paul-Ehrlich-Institut is competent, so BfArM takes the cytotoxics, kinase inhibitors and hormonal agents while PEI takes the biologicals and advanced therapies. Based in Bonn and Cologne with about 1,350 staff and reporting to the Federal Ministry of Health, it licenses and registers medicines through the national, mutual recognition and decentralised procedures, supplies rapporteurs and assessors to the European Medicines Agency's centralised procedure, which is the route almost every new cancer medicine actually takes, assesses risks for medical devices, controls narcotics and publishes the German medical coding systems.

It authorises clinical trials under section 42(2) AMG alongside a Land ethics committee, through CTIS under EU Regulation 536/2014, with a shortened timetable and a specialised ethics committee added by the Medizinforschungsgesetz. Two further roles matter for oncology: the expert groups on off-label use under section 35c SGB V are seated at BfArM and their assessments are what the Gemeinsamer Bundesausschuss turns into the list of off-label uses statutory insurance will pay for, and since 2024 BfArM has been the platform operator for the section 64e SGB V model project on genome sequencing, licensing the clinical data nodes and genome computing centres and maintaining the public application register.