The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other international regulatory agencies, according to the UK-based Centre for Innovation in Regulatory Science (CIRS).
CIRS measured approval times for six regulatory authorities from 2008 to 2017 — including the FDA, the European Medicines Agency, Australia’s Therapeutic Goods Administration, Japan’s Pharmaceuticals and Medical Devices Agency, Health Canada and Swissmedic — and found that the FDA had the shortest median approval time in 2017 at 243 days.
CIRS noted that 40 percent of FDA’s new active substance approvals were given a breakthrough designation. The PMDA trailed the FDA with 333 days for median approval times, followed by Health Canada (350), TGA (364), EMA (419) and Swissmedic (470).
