Regulatory Focus™ > News Articles > Which Region is Better for Diabetes Drug Approvals: US or EU?

Which Region is Better for Diabetes Drug Approvals: US or EU?

Posted 09 July 2014 | By Alexander Gaffney, RAC

Which Region is Better for Diabetes Drug Approvals: US or EU?

US pharmaceutical regulators at the Food and Drug Administration (FDA) easily best their EU counterparts at the European Medicines Agency (EMA) when it comes to approving new diabetes treatments, a new report claims.

The report, issued on 7 July 2014 by the regulatory consulting group Context Matters, looked at a study issued earlier this year in the New England Journal of Medicine (NEJM) which compared new drug approvals by FDA, EMA and Health Canada.

That study found that FDA "has provided more rapid reviews of applications involving novel therapeutics than have the EMA and Health Canada and that the vast majority of the novel therapeutics first received approval for use in the United States."

That finding validated earlier findings by the same researchers, as described by Regulatory Focus in 2012.

The Context Matters researchers, however, took issue with how FDA approvals were compared with those of EMA in that research. The NEJM article, they said, assumed that FDA approval was the same as approval from EMA's Committee for Medicinal Products for Human Use (CHMP).

The problem, they note, is that FDA approval allows for instant access to the market, while a drug approval by the CHMP must await final approval from the European Commission (EC) before it is allowed to be marketed throughout the EU.

To see what kind of effect that additional wait might have on market access, Context Matters looked at 13 diabetes drugs approved in both the US and EU, and compared their approval dates from FDA, EMA and the EC.

The findings not only validated the original NEJM research, they said, but actually showed that the benefit to filing products in the US was even more pronounced than originally known.

Context Matters Diabetes Research

"We found that the FDA was consistently first and faster than its European counterpart to approve the 13 new treatments, with the FDA approving 11 ahead of the EMA, and completing 9 of the 13 regulatory reviews faster than the EMA," the group wrote. "We also noted that the FDA began its regulatory review before the EMA at a median time of 103 days sooner."


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