title: Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.
abstract: This article analyzes the role of regulatory authorities in facilitating innovation in the pharmaceutical sector. We describe how regulators are expanding their role to be not only gatekeepers but also enablers of development. They have already responded to the challenging and changing environment by moving toward a proactive attitude beyond evaluation of products, thereby more actively contributing to their development. Regulators have to continuously evolve their knowledge and standards alongside evolution in science. Creation of supportive regulatory frameworks and multistakeholder interaction will help address unmet regulatory needs.
authors.affiliation: Innovation Task Force, Pharmacogenomics and Nanomedicines Drafting Group, European Medicines Agency (EMA), London, UK. falk.ehmann@ema.europa.eu
authors.forename: F
authors.initials: F
authors.lastname: Ehmann
authors.forename: M
authors.initials: M
authors.lastname: Papaluca Amati
authors.forename: T
authors.initials: T
authors.lastname: Salmonson
authors.forename: M
authors.initials: M
authors.lastname: Posch
authors.forename: S
authors.initials: S
authors.lastname: Vamvakas
authors.forename: R
authors.initials: R
authors.lastname: Hemmings
authors.forename: H G
authors.initials: HG
authors.lastname: Eichler
authors.forename: C K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D017277:Drug Approval; D015195:Drug Design; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence; D006801:Humans; D009936:Organizational Innovation; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000600:supply & distribution
chemical_list: D004364:Pharmaceutical Preparations