Among Global Drug Regulators, FDA Still the Best, But Others Are Catching up—Fast

Regulatory NewsRegulatory News | 14 January 2015 |  By 

Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS).

Background: Study

CIRS' analysis looked at new drug approval decisions made over the past decade by six regulators:

  • The US Food and Drug Administration (FDA)
  • The European Medicines Agency (EMA)
  • Japan's Pharmaceutical and Medical Devices Agency (PMDA)
  • Health Canada
  • Switzerland's Swissmedic
  • Australia's Therapeutic Goods Administration (TGA)

A Convergence in Approval Times

The data show a remarkable convergence among the median approval time among all six regulators since 2004, when the best regulator (FDA) was approving new drugs in 400 days on average, and Health Canada was taking more than 900 days on average.

 CIRS - Average New Drug Approval Times

Since 2004, every single regulatory body has exhibited an improvement in the time it takes to approve each medicine on average, though not all improvements have consistently trended downward.

FDA, for example, approves new drugs in about 300 days on average—25% faster than it did in 2004, but still not as fast as it approved drugs in 2005, when it approved them in about 250 days on average.

                Read more about FDA's average new drug approval times in our report here.

Big Improvements

CIRS - Variation in Review Times

Japan's PMDA and Health Canada may have had the most notable improvements over the past decade. In 2006, for example, PMDA approved drugs in more than 800 days on average. By 2013, it had the second best average approval times of any regulator. Health Canada made similar improvements, bringing down average approval times from 900 days in 2004 to around 350 days on average for the third best showing of the six regulators.

Australia's TGA averaged about 400 days per review, while EMA and Swissmedic both clocked in at around 500 days on average.

CIRS' data also shows that the consistency of drug reviews has improved markedly, with all regulators approving drugs within more predictable timeframes. For example, in 2004 FDA approved 50% of all drugs between 200 and 900 days. By 2013, it ranged between around 250 days and 350 days. Japan's PMDA saw even more remarkable improvements, approving 50% of all applications between 250-350 days in 2013 compared to 600 to 1,200 days in 2006.

CIRS data also indicates that expedited approval applications, such as FDA's accelerated approval pathway, do not appear to have caused the drop in approval times across all regions, though the three regulators with the slowest average approval times used expedited approval pathways the least.


CIRS Analysis

CIRS Blog Post


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