Japan Outpaces Europe, U.S. in 2014 Drug Approvals

Japan’s Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science.

CIRS found that the PMDA has been able to cut median approval time from more than 800 days in 2006 to 306 days last year, while the Food and Drug Administration and European Medicines Agency approval times stayed about the same.

Japan’s median approval time for 52 new drugs was faster than the FDA’s 343 days for 45 drugs and the EMA’s 418 days for 30 drugs. The report claims that the number of approvals among the three regulators was the largest in the 10 years CIRS has been tracking them.

The 2014 record extended to orphan drug approvals as well, as the EMA used expedited review for 14 percent of such approvals while the FDA and PMDA used that route for 69 percent and 100 percent, respectively. The PMDA approved 19 orphan and 33 non-orphan drugs, the FDA approved 21 orphans and 24 non-orphans and the EMA approved 13 orphans and 17 non-orphans.

Over the last decade, the FDA and PMDA approved orphan drugs more quickly than non-orphan drugs, while the EMA showed little difference in approval times.

Read the CIRS study here www.fdanews.com/08-03-15-drugapprovals.pdf. — John Bechtel


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