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The US and European Regulatory Systems: A Comparison

Redmond, Kathy MSc, RN

Journal of Ambulatory Care Management: April/May/June 2004 - Volume 27 - Issue 2 - p 105–114
Articles

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.

Ms Redmond is editor, CancerFutures.

Corresponding author: Kathy Redmond, MSc, RN, Corso Italia 16, 20122 Milan, Italy (e-mail: Kathy.Redmond@tin.it).

© 2004 Lippincott Williams & Wilkins, Inc.