title: The US and European regulatory systems: a comparison.
abstract: Regulatory agencies have a responsibility to ensure that high-quality safe, and effective medicines are made available to patients in a timely manner. Despite the fact that all regulators worldwide share the same aims, they do not adopt a consistent approach to drug approval, and as a result, medicines are often approved quicker in some countries than in others. There is a significant difference in cancer drug approval time between the US Food and Drug Administration and the European Medicines Evaluation Agency (EMEA; 304 versus 448 days). There are a number of reasons for this difference, not least the fact that EMEA appears to be much more conservative in its approach to fast-tracking the evaluation of promising cancer drugs. Increasing dialogue between the different stakeholder groups involved may help address this unsatisfactory situation.
authors.affiliation: Kathy.Redmond@tin.it
authors.forename: Kathy
authors.initials: K
authors.lastname: Redmond
mesh_terms: D000970:Antineoplastic Agents / Q000145:classification; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D005060:Europe; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents