title: [Interplay between marketing authorization and early benefit assessment of drugs].
abstract: The early benefit assessment of newly approved drugs with new active substances or new applications that came into force on 1 January 2011 still presents a challenge to the parties involved. This article highlights the interplay between drug marketing approval and early benefit assessment. The constellation of a European, and even an international, largely harmonized, drug authorization process, with a mostly nationally regulated drug reimbursement situation causes inevitably friction, which could be reduced through joint advice discussions during the planning phase for pivotal studies. In 2013, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) provided 439 scientific advice procedures, compared with 98 advice meetings held at the Federal Joint Committee (G-BA), for 12 of which the BfArM or PEI provided written advice. The numbers of advice meetings held at the G-BA are increasing; however, the national competent authorities are involved in only a fraction of these. From the perspective of the national competent authorities, prompt and consistent involvement in the advice procedures regarding early benefit assessment would be useful and desirable.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland, peggy.beinlich@bfarm.de.
authors.forename: Peggy
authors.initials: P
authors.lastname: Beinlich
authors.forename: J
authors.initials: J
authors.lastname: Müller-Berghaus
authors.forename: T
authors.initials: T
authors.lastname: Sudhop
authors.forename: S
authors.initials: S
authors.lastname: Vieths
authors.forename: K
authors.initials: K
authors.lastname: Broich
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003362:Cost-Benefit Analysis / Q000379:methods / Q000458:organization & administration*; D017277:Drug Approval / Q000379:methods / Q000458:organization & administration*; D019317:Evidence-Based Medicine / Q000379:methods / Q000458:organization & administration; D005858:Germany; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment / Q000379:methods / Q000458:organization & administration*; D016896:Treatment Outcome