Review times for new drugs and submission delays among the FDA and 4 international regulators, 2014–22

Abstract

Factors influencing the timing of regulatory submission for new drugs across countries are poorly understood. We identified all new drugs approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) during the period 2014–18 and tracked their regulatory submissions to the US, the European Union, Canada, Japan, and Australia through 2022. We assessed whether disease area, orphan status, therapeutic value, market size, and launch price were associated with submission delays. The FDA received the highest proportion of first submissions (70 percent). Median submission delays ranged from zero months (FDA) to 18.5 months (Australia). The range of median regulatory review times was small (9.2–14.1 months) compared with the range of median submission delays. Drugs with moderate-to-high therapeutic value were associated with a six-month earlier submission time compared to drugs with low therapeutic value, on average. Higher-price drugs were associated with earlier submission, on average. Overall, cross-national differences in drug availability largely reflected differences in submission, not regulatory review, times. Although the US had greater and faster availability of novel therapeutics, the difference was smaller for drugs that offered moderate-to-high therapeutic value.