OBJECTIVES: Accelerated marketing authorization (AMA) aims to make medicines with a major public health impact available as quickly as possible. Although accelerated approval pathways in the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have reduced review time to approval, evidence of the use of AMA remains sparse.

Study objectives:

• Estimate time to approval using accelerated pathways by the EMA and FDA since 2015
• Estimate time to approval in AMA pathways for other developed countries: Health Canada, PMDA (Japan) and TGA (Australia) comparing with EMA and FDA
• Describe differences between agencies that may influence time to decision

METHODS: We identified drugs approved by FDA and EMA since 2015 that used AMA. Findings were cross-checked with databases for Health Canada, PMDA and TGA. Information extracted included: drug name, indication, submission and approval dates. Average time to approval was compared across the five agencies.

RESULTS: Of the 11 drugs granted accelerated approval by EMA and FDA, 10 were considered under AMA pathways in Japan, four in Canada and zero in Australia. Four-fifths of the indications were for oncology. The median (range) time to approval in days was: 158 (91, 298) for FDA, 238 (204, 264) for Health Canada, 253 (220, 313) for PMDA and 287 (217, 527) for EMA. The criteria to grant AMA varied across agencies.

CONCLUSIONS: There were noticeable differences in the approach to AMA in the five agencies. The list of drugs with AMA in Japan reflected the inclusion in accelerated pathways in FDA and EMA. Coverage was lower in Canada and Australia. FDA AMA pathways offered the fastest access to market. AMA pathways can facilitate quicker patient access to breakthrough medicines, although there may be further delays for reimbursement. AMA pathways remain underused in Canada and Australia.