title: [Role of regulatory authorities in healthcare delivery for the elderly].
abstract: The population older than 60 years is growing faster than any other age group, as a result of longer life expectancy and declining fertility rates. Although population aging is a marker of the success of public health policies, it also challenges the established way of implementing such policies, which require a new strategic approach. Taking into account current achievements in this field, regulatory agencies should undertake additional efforts to ensure that the needs of older persons are taken into account in the development and evaluation of new medicines, to improve our understanding of best methodologies to evaluate the benefit-risk ratio for usage of medications in older patients. Health professionals need to be ensured that the use of newly approved medicines in the intended population is supported by relevant data on the benefit-risk balance. A representative population of patients must cover the whole age range when studied in the preauthorization phase. Another need is the improvement of available information to patients and prescribers, to support safer use of medications. During drug development, a dialogue with regulators should be held to be sure older people needs will be taken into consideration. Collection of data from all possible sources should be optimized, to avoid underreported adverse events in elderly people.
authors.forename: Massimo
authors.initials: M
authors.lastname: Fini
authors.forename: Maurizio
authors.initials: M
authors.lastname: Volterrani
mesh_terms: D000368:Aged; D000375:Aging; D006801:Humans; D008017:Life Expectancy; D012106:Research; D018570:Risk Assessment