{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T04:25:45Z","timestamp":1787199945202,"version":"build-2736575974"},"reference-count":29,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp; Syst Pharma"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The accelerated development of innovative anticancer therapies has led to the early approval of an increasing number of drugs. However, clinical evidence available at the time of approval is often limited, necessitating additional post\u2010marketing studies to supplement safety and efficacy data. Therefore, post\u2010marketing requirements (PMRs) have gained greater regulatory importance. Nevertheless, the current landscape of PMRs for anticancer drugs in Japan has not been clearly characterized. In this study, we aimed to characterize the status, content, and trends of PMRs for anticancer drugs approved in Japan. We reviewed publicly available regulatory documents for anticancer drugs approved in Japan between 2001 and 2024 and extracted data on background characteristics and PMRs. Analysis of 471 anticancer agents identified 328 (69.6%) drugs requiring at least one PMR. The temporal trend analysis showed a consistent increase in the number of drugs requiring PMRs after 2011. Among 453 PMR assignments, the development and implementation of a risk management plan (RMP) was the most frequent PMR type (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009254, 56.1%), followed by post\u2010marketing all\u2010case surveillance (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009147, 32.5%). Twelve drugs (2.6%) required post\u2010marketing clinical trials, among which one (0.2%) involved dose optimization. In conclusion, our findings show that PMRs for anticancer drugs in Japan are predominantly focused on safety monitoring, and that only one PMR was related to dose optimization. These findings suggest that further consideration may be needed in Japan to strengthen post\u2010approval evidence generation for dose setting and to support more evidence\u2010based dose selection.\n                  <\/jats:p>","DOI":"10.1002\/psp4.70309","type":"journal-article","created":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T04:19:02Z","timestamp":1785298742000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Post\u2010Marketing Requirements for Anticancer Drugs Approved in Japan, 2001\u20132024: A Cross\u2010Sectional Analysis"],"prefix":"10.1002","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-0323-6620","authenticated-orcid":false,"given":"Aina","family":"Tsuno","sequence":"first","affiliation":[{"name":"Regulatory Science Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-0086-7643","authenticated-orcid":false,"given":"Hiroe","family":"Kitagaki","sequence":"additional","affiliation":[{"name":"Regulatory Science Meiji Pharmaceutical University  Tokyo Japan"},{"name":"Early Clinical Development Clinical Operations Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0117-3961","authenticated-orcid":false,"given":"Hideki","family":"Maeda","sequence":"additional","affiliation":[{"name":"Regulatory Science Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,28]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2015.10.005"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-023-06388-8"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1801222"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2019.07.007"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1709185"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2022.4226"},{"key":"e_1_2_10_8_1","first-page":"1","article-title":"The Importance and Utility of Post\u2010Market Drug Safety Monitoring in Cancer Therapy","volume":"25","author":"Lev\u00eaque D.","year":"2025","journal-title":"Expert Opinion on Drug Safety"},{"key":"e_1_2_10_9_1","unstructured":"U.S. Food and Drug Administration \u201cProject Optimus: Reforming the Dose Optimization and Dose Selection Paradigm in Oncology \u201d(2023) https:\/\/www.fda.gov\/about\u2010fda\/oncology\u2010center\u2010excellence\/project\u2010optimus."},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2023.3292"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3722"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-022-01461-0"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.70304"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.8875"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040297"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2021.12.021"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1200\/OP.21.00909"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12745"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-022-00480-3"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.769"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2016.02.016"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1080\/21678707.2021.2047021"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.12454"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.38793"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.24406"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2019.0462"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.9415"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjonc-2024-000659"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.31061"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2679"}],"container-title":["CPT: Pharmacometrics &amp; 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