FIGURE 1.

Conditional early approval in Japan, accelerated approval in the United States, and conditional marketing authorization in the European Union. (a) NME granted the CEA in Japan and those granted the AA/CMA in the United States/European Union between 2017 and 2021. The proportion of the AA/CMA for NME in the United States/European Union has increased recently, whereas that of the CEA in Japan remains low. The difference in the number of NME between Japan and the United States/European Union became small. (b) Scheme of the CEA in Japan and the AA/CMA in the United States/European Union. The CEA/AA/CMA may be granted based on small‐scale, dose‐finding clinical studies investigating drug efficacy and safety using a surrogate endpoint. The PMDA/MHLW requests postmarketing surveillance when granting the CEA. The FDA requests postmarketing clinical trials when granting the AA and sometimes revokes approval if the trials do not provide evidence of clinical benefits. The EMA request additional postmarketing data, which can include clinical trial results as well as postmarketing surveillance studies. The CMA is valid for 1 year and can be renewed annually. (c) The gap of use of the CEA and the AA/CMA results in drug lag due to differences in the policies of regulatory agencies. There is an increase in drug development strategy in which a new drug application under the AA/CMA program is filed with the FDA/EMA based on the results of an interim analysis using surrogate end points, and the full approval is filed based on the results of the final analysis of global clinical trials. AA, accelerated approval; CEA, conditional early approval; CMA, conditional marketing authorization; EMA, the European Medicines Agency; EU, European Union; FDA, the US Food and Drug Administration; JP, Japan; MHLW, the Ministry of Health, Labour and Welfare; NME, new molecular entity; PMDA, the Pharmaceuticals and Medical Devices Agency; US, United States.