The Pharmaceutical Industry at a Glance Comparison of New Drug Approval Status and Examination Periods in Japan, the U.S. and Europe Focusing on 2018 Approval Results

The NMEs were those classified as "New active substance".

In addition, as special measures on pharmaceutical affairs, Japan has Priority Review, Expedited Review, Orphan, Fast Track, Breakthrough Therapy, and Accelerated Approval systems, while the United States has Priority Review, Orphan, Fast Track, Breakthrough Therapy, and Accelerated Approval systems, and Europe has Orphan, Conditional Approval, Exceptional Circumstances, Accelerated Assessment, and Priority Medicine (PRIME). The details of each special regulatory action are summarized in the Supplement.

The number of new drugs approved in Japan, the United States, and Europe over the past five years (2014-2018) is shown in Figure 1.

In Japan, 108 products and 37 NMEs were approved in 2018, 23 and 13 more, respectively, than in 2017; fewer than in 2014 and 2016, and similar to 2015. In contrast, the U.S. had 139 approved products and 59 NMEs, more than in 2017, when there were more approved products, both the highest numbers in the past five years. Europe had 141 approved items and 45 NMEs in 2018, the highest number in the past five years (the same number of NMEs as in 2016).

We then examined the number of NMEs approved in Japan, the U.S., and Europe over the past five years (2014-2018) that received special regulatory action (Figure 2).

Of the 37 NMEs approved in Japan in 2018, 13 (35.1%) received priority review (including orphan drugs), 11 (29.7%) were orphan drugs, and two were designated under the Pioneer Review Designation System (the other of these designated items was a new-dose drug) ⁷⁾. The overall percentages of priority review and orphan drugs have remained roughly 35-45% and 30-35%, respectively, since 2013, and did not show any particular upward trend in 2018. In the U.S., of the 59 NMEs approved in 2018, 43 (72.9%) were Priority review and 34 (57.6%) were Orphan designated, the highest percentages since 2010. On the other hand, 24 (40.7%) were Fast Track-designated and 14 (23.7%) were Breakthrough Therapy-designated, with Fast Track being the same as before 2017 and Breakthrough Therapy being the same as in 2016 and 2017, while the The percentages were declining. For Europe, of the 45 NMEs approved in 2018, 17 (37.8%) were designated Orphan, while Accelerated Assessment, Conditional approval, and Exceptional Circumstances were approved for four (4 8.9%), 2 (4.4%), and 3 (6.7%), which were as few as before 2017 (excluding Conditional approval in 2016). In addition, two (4.4%) PRIME-designated products, initiated as a measure to promote new drug development in Europe, were approved for the first time in 2018.

The most significant feature of 2018 was the significant increase in the number of orphan drug approvals in the United States. The increasing development of Orphan drugs in the U.S. ⁸⁾, where new drugs are often developed first in the world, could become a global trend, including in Europe and Japan.

Table 1 shows the review periods in Japan, the U.S., and Europe for 2018-approved products. the respective median review periods (median) for 2018-approved products were 9.9 months in Japan, 10.0 months in the U.S., and 12.6 months in Europe, similar for Japan and the U.S. and longer for Europe, similar to 2017. with respect to NMEs, the 2018-approved The median review period was 10.3 months in Japan, 8.0 months in the U.S., and 14.1 months in Europe. Japan was 2.3 months longer than the U.S. and 3.8 months shorter than Europe, also similar to 2017. In the U.S., the percentage of Priority Review-designated items in NMEs is over 70%, which is higher than that of Priority Review in Japan and Accelerated Assessment in Europe, leading to a shorter median review time.

Table 2 shows the review periods (in months) of the 2018 approved items that were designated for special measures on pharmaceutical affairs (Japan: Priority Review, Pioneer Review Designation System; U.S.: Priority review; Europe: Accelerated Assessment) to shorten the review period. In Japan, the number of approvals for priority review items increased in 2018 for both all approved items and NMEs, but the median review period (median) was 8.0 months, the same as in 2017, and the review period was shorter than that for regular review items. In addition, three items (including two NMEs) were approved in 2018 for the first time as designated items under the Priority Review Designation System, but the review period was very short at around 5 months. In the U.S., the number of approved Priority Review-designated items increased significantly in 2018 compared to 2017 for both all approved items and NMEs, but the median review period for these items was about 8 months, the same as in 2017, and shorter than that for Standard Review items. The median review time for Accelerated Assessment-designated items in 2018 was 8.2 months, the same as in 2017, and shorter than that for items not designated for Accelerated Assessment, although the percentage of items receiving priority review in Europe is lower than in Japan and the United States. The median review time for Accelerated Assessment-designated items in 2018 was 8.2 months, continuing the trend from 2017. In addition, two items with PRIME designation (Kymriah and Yescarta) were approved, but since these items had PRIME designation, the application of Accelerated Assessment was considered at the time of application, but during the review process, Accelerated However, during the review process, it was determined that Accelerated assessment was not ^{appropriate9)},10 and a standard review was conducted. The review periods for these items were 13.0 and 9.8 months.