Approval Trends At FDA, EMA, And PDMA

CIRS Report

The Centre for Innovation in Regulatory Science (CIRS) released a report titled, “New Drug Approvals in ICH Countries 2004-2013: Focus on 2013.” Authors analyze the differences in the three regulatory agencies: The FDA, European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PDMA), Japan’s regulatory agency. The report also describes the approval process at each, and provides a list of approved drugs. In 2013, notable similarities and differences emerged.

• The three agencies approved similar numbers of New Molecular Entities (NCEs), also called New Active Substances (NASs). The FDA approved 29, Europe approved 30, and Japan approved 28.
• The U.S. approved 25 percent fewer drugs than 2012, and Japan approved 20 percent fewer.
• The EMA increased approvals by 43 percent compared to 2012.
• Japan’s median approval time in 2013 was 342 days, in Europe it was 478 days, and in the U.S. it was 304 days, making the FDA the fastest of the three.
• The FDA was also faster during the 2004-2013 time period, as approvals averaged 304 days in the U.S., 459 days in Europe, and 487 days in Japan.

FDA Response

The Commissioner of the Food and Drug Administration (FDA) published an article in the FDA Voice regarding the FDA’s performance in reviewing new drugs. Margaret A. Hamburg, M.D. is pleased with the results of a new study performed by the Centre for Innovation in Regulatory Science (CIRS), based in London. In her discussion of the new CIRS report, Hamburg emphasizes the FDA’s drug approval record in relation to the EMA and PDMA. Dr. Hamburg said, “It turns out that FDA was consistently faster than its regulatory counterparts over the time frame 2004-2013.”   

Hamburg attributes the FDA’s record to the agency’s “innovative and flexible approach to drug development.” Programs such as accelerated approval, priority review, breakthrough therapy, and fast track designation also impacted approval times. For example, almost half of the FDA approved NMEs received priority review, with average decisions made in six months and not the standard ten months.