title: Adaptive licensing: taking the next step in the evolution of drug approval.
abstract: Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The concept of AL embraces a range of perspectives. Some see AL as an evolutionary step, extending elements that are now in place. Others envision a transformative framework that may require legislative action before implementation. This article summarizes recent AL proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: H-G
authors.initials: HG
authors.lastname: Eichler
authors.forename: K
authors.initials: K
authors.lastname: Oye
authors.forename: L G
authors.initials: LG
authors.lastname: Baird
authors.forename: E
authors.initials: E
authors.lastname: Abadie
authors.forename: J
authors.initials: J
authors.lastname: Brown
authors.forename: C L
authors.initials: CL
authors.lastname: Drum
authors.forename: J
authors.initials: J
authors.lastname: Ferguson
authors.forename: S
authors.initials: S
authors.lastname: Garner
authors.forename: P
authors.initials: P
authors.lastname: Honig
authors.forename: M
authors.initials: M
authors.lastname: Hukkelhoven
authors.forename: J C W
authors.initials: JC
authors.lastname: Lim
authors.forename: R
authors.initials: R
authors.lastname: Lim
authors.forename: M M
authors.initials: MM
authors.lastname: Lumpkin
authors.forename: G
authors.initials: G
authors.lastname: Neil
authors.forename: B
authors.initials: B
authors.lastname: O'Rourke
authors.forename: E
authors.initials: E
authors.lastname: Pezalla
authors.forename: D
authors.initials: D
authors.lastname: Shoda
authors.forename: V
authors.initials: V
authors.lastname: Seyfert-Margolis
authors.forename: E V
authors.initials: EV
authors.lastname: Sigal
authors.forename: J
authors.initials: J
authors.lastname: Sobotka
authors.forename: D
authors.initials: D
authors.lastname: Tan
authors.forename: T F
authors.initials: TF
authors.lastname: Unger
authors.forename: G
authors.initials: G
authors.lastname: Hirsch
mesh_terms: D000818:Animals; D003657:Decision Making; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods*; D005062:European Union; D006301:Health Services Needs and Demand / Q000331:legislation & jurisprudence* / Q000458:organization & administration*; D006801:Humans; D008004:Licensure / Q000331:legislation & jurisprudence*; D014481:United States