(U.S./Canada/Europe) Cross-comparison of cancer drug approvals at three international regulatory agencies

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ABSTRACT

Background

The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies—Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)—and to explore differences in the drug approval processes that might contribute to any disparities.....

Methods

The publicly available Health Canada Drug Product Database was surveyed for all marketed antineoplastic agents approved between 1 January 2005 and 1 June 2013. For the resulting set of cancer drugs, public records of sponsor submission and approval dates by Health Canada, the fda, and the ema were obtained.

RESULTS

To facilitate this comparative analysis of times from initial drug submission to approval by each regulatory agency, the period from the filing of a submission by a sponsor until the approval for marketing was granted was evaluated. On average, the time to approval (tta) is approximately 14.0 months for Health Canada and 14.2 months for the ema; it is 6.9 months for the fda (Tables i and ii).