International Regulators Closing Approval Time Gap With FDA

January 21, 2015

Global drug regulators have reduced drug approval times over the last 10 years, and while the FDA remains the fastest at approving new drugs, other regulators are closing the gap.

According to a new report that tracks the time from submission to sign-off in six regulatory agencies over a 10-year period, the FDA reduced the median time required to approve new active substances to 304 days in 2013, from more than 400 days in 2004.

Japan’s Pharmaceuticals and Medical Devices Agency clocked in as the next fastest, with a median approval time of 342 days in 2013, down from around 600 in 2004.

Health Canada, the European Medicines Agency, Swissmedic and Australia’s Therapeutic Goods Administration also markedly reduced their median approval times as they closed in on the FDA. Swissmedic was the slowest of the bunch, with a median approval time of 511 days in 2013.

The report by the Centre for Innovation in Regulatory Science concluded the gap from fastest to slowest median approval time was about 500 in 2004. By 2013, that window had shrunk to 200 days.

Read the report at www.fdanews.com/01-14-2015-International-Drug-Approvals.pdf. — Bryan Koenig