Approval and delay status of United States -approved new drugs (2010-2023) in European Union, Japan, and China.

backgroundChina has long been faced with a drug lag. A decade has passed since China launched its pharmaceutical regulatory reforms, and related policies have been continuously optimized, yet their effectiveness remains to be evaluated. This retrospective analysis uses the United States as a reference to compare drug lags among the European Union, Japan, and China, and investigates key factors underlying lags between the US and China.

methodsThis study examined new drugs first approved by the US Food and Drug Administration (FDA) between 2010 and 2023. We conducted a descriptive analysis of key characteristics, including approval dates, drug categories, and development strategies. We further investigated factors associated with drug approval lag using the Mann-Whitney U test and analysis of covariance (ANCOVA).

resultsFrom 2010 to 2023, the FDA approved 516 new drugs. Of these, 399, 301, and 266 were authorized by the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA), and the National Medical Products Administration (NMPA), respectively. China's drug approval lag decreased from 1,667 days in 2010-2014 to 635 days in 2020-2023. Furthermore, we found that the EMA's lag was mainly concentrated in the review phase, the PMDA's lag was mainly concentrated in the submission phase, and the NMPA showed a substantial lag in both phases. Factors influencing drug approval lag in China include whether conditional approval was granted by the NMPA, whether FDA breakthrough therapy designation was obtained, the region of the Marketing Authorization Holder whether a domestic development strategy in China was adopted, and whether external collaborative research and development was used. From a clinical development strategy perspective, drugs undergoing Multi-Regional Clinical Trial and early bridging trials experience shorter approval lag.

conclusionsSince China's pharmaceutical regulatory reforms, the number of newly approved drugs has increased, and approval lag has shortened, although it remains longer than that of the EMA and PMDA. We recommend that the NMPA improve review efficiency to reduce approval lag and adopt more favorable policies to encourage earlier development and submission in China, thereby alleviating submission lag.