Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Office of New Drug 2, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Clin Pharmacol Ther. 2021 May;109(5):1265-1273. doi: 10.1002/cpt.2080. Epub 2020 Nov 15.
The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first-in-world approvals and clarify the current drug lag. The new drug and the drug lag were defined as a drug with a new active substance and a difference between the approval date in Japan and the international birth date, respectively. Among 400 new drugs approved in Japan during the last 12 years, 80 (20.0%) were first approved in Japan, and 320 were outside Japan (the United States: 202, 50.5%; Europe: 82, 20.5%; other regions: 36, 9.0%). Of these, 45 new drugs have not yet been approved outside Japan, and the remaining 355 have been globally approved in Japan and overseas. The number of new drug approvals were the largest in oncology followed by metabolic/endocrine and infectious diseases. The median drug lags (year) among all 400 new drugs and 355 new drugs with global approvals were 4.3 and 4.7 in the first tertile (2008-2011), 1.5 and 2.6 in the second tertile (2012-2015), and reduced to 1.3 and 2.2 in the third tertile (2016-2019), respectively. Substantial drug lag remains in neurology, psychiatry, and therapeutic areas where the number of new drug approvals was relatively small. Collectively, one-fifth of the new drugs approved in Japan are first-in-world approvals. Drug lag has been greatly decreased, although it still exists.
药品和医疗器械管理局(PMDA)近年来批准了数百种新药。我们回顾性分析了 2008 年至 2019 年在日本批准的新药,并确定了全球首次批准的新药,并阐明了目前的药物滞后情况。新药和药物滞后分别定义为具有新活性物质的药物以及日本批准日期与国际出生日期之间的差异。在过去 12 年中,日本批准的 400 种新药中,有 80 种(20.0%)为日本首次批准,320 种为日本以外地区(美国:202,50.5%;欧洲:82,20.5%;其他地区:36,9.0%)。其中,45 种新药尚未在日本以外地区获得批准,其余 355 种新药在日本和海外已获得全球批准。在所有 400 种新药和 355 种具有全球批准的新药中,批准新药数量最多的是肿瘤学,其次是代谢/内分泌和传染病学。在所有 400 种新药和 355 种具有全球批准的新药中,药物滞后中位数(年)在第一三分位数(2008-2011 年)为 4.3 年和 4.7 年,在第二三分位数(2012-2015 年)为 1.5 年和 2.6 年,在第三三分位数(2016-2019 年)分别减少到 1.3 年和 2.2 年。神经病学、精神病学和新药批准数量相对较少的治疗领域仍然存在大量的药物滞后。总体而言,日本批准的新药中有五分之一是全球首次批准的新药。虽然仍然存在药物滞后,但已经大大减少。