Abstracts by key term: randomized controlled trials (RCT)
On January 1, 2011, the law to reorganize the pharmaceutical market (AMNOG) came into force. Since the AMNOG came into force, pharmaceutical companies (companies) have had to submit evidence of the additional benefit of the new active ingredient for all drugs with new active ingredients as of the date of market launch. According to the draft bill for AMNOG, one of the objectives of this law was to create “reliable framework conditions for innovation, care for insured persons and job security” (1). The research-based pharmaceutical drug manufacturers have faced the extremely high administrative effort associated with dossier creation. In public statements, IQWiG certifies that the pharmaceutical companies' dossiers are of good quality. After three years of experience with early benefit assessment, the question now arises as to whether AMNOG is an obstacle or an accelerator for innovation.