title: Advancing the science of medicines regulation: the role of the 21st-century medicines regulator.
abstract: The history of medicines regulation is punctuated with sudden swings in focus mandated by a public injured by medicines and skeptical of regulators' abilities to protect them. As stakeholder communities and the science that undergirds medicines have both grown more sophisticated, seemingly conflicting mission equities, such as public health protection vs. promotion or population vs. individual patient product development focus, have created new challenges to defining the mission and role of twenty-first-century medicines regulators. The role of medicines regulators as a nationally focused, retrospective assessor of data is rapidly shifting to that of a prospective generator of public data and tools to help drive what has now become a global product development and regulatory enterprise that is fast gaining recognition as an integral part of any truly effective twenty-first-century health-care system. This article discusses this evolution and describes how regulatory science will help to both drive and define it.
authors.affiliation: US Food and Drug Administration, Silver Spring, Maryland, USA. Murray.Lumpkin@fda.hhs.gov
authors.forename: M M
authors.initials: MM
authors.lastname: Lumpkin
authors.forename: H-G
authors.initials: HG
authors.lastname: Eichler
authors.forename: A
authors.initials: A
authors.lastname: Breckenridge
authors.forename: M A
authors.initials: MA
authors.lastname: Hamburg
authors.forename: T
authors.initials: T
authors.lastname: Lönngren
authors.forename: K
authors.initials: K
authors.lastname: Woods
mesh_terms: D003695:Delivery of Health Care / Q000331:legislation & jurisprudence / Q000639:trends*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D011446:Prospective Studies; D012189:Retrospective Studies
chemical_list: D004364:Pharmaceutical Preparations