title: Regulation of vaccines: strengthening the science base.
abstract: This paper aims to review the history of development of vaccine regulatory approaches, to assess practices that may be barriers to access to innovative products, and to suggest possible approaches to address these practices. Despite the appearance of new vaccines in the past few years, many vaccines are based on old technologies, and are still subject to regulatory practices devised many years ago. Vaccine regulation began with a foundation on vaccine testing, and only in response to tragedies associated with vaccine use did new concepts begin to be defined. Vaccine regulation now includes a range of functions that cover the entire continuum of vaccine development and use. However, some regulatory practices, such as the continuing dependence on outdated animal tests, have not kept pace with these changes. Other practices, such as the continual raising of the standard of Good Manufacturing Practice (GMP) compliance, or the move to increasingly larger phase 3 clinical trials, appear to be based more on perceived risks than on firm scientific principles. The future of effective regulation for vaccines that will allow innovation while protecting the public health must be based on three guiding principles: a firm science base for policies and decisions, a risk-based approach to implementation of regulatory oversight, and support for regulatory research to inform these activities. These should be implemented in a setting of international harmonization.
authors.affiliation: University of Maryland School of Medicine, Center for Vaccine Development, Montpellier, France. milstien@medicine.umaryland.edu
authors.forename: Julie B
authors.initials: JB
authors.lastname: Milstien
mesh_terms: D003362:Cost-Benefit Analysis; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D014612:Vaccines / Q000009:adverse effects / Q000191:economics / Q000592:standards*
chemical_list: D014612:Vaccines