{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T06:59:50Z","timestamp":1776754790210,"version":"3.51.2"},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,4,14]],"date-time":"2023-04-14T00:00:00Z","timestamp":1681430400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP21mk0101137h0003"],"award-info":[{"award-number":["JP21mk0101137h0003"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP22mk0101227h0001"],"award-info":[{"award-number":["JP22mk0101227h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neuropsychopharm Rep"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies. Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.<\/jats:p>","DOI":"10.1002\/npr2.12339","type":"journal-article","created":{"date-parts":[[2023,4,14]],"date-time":"2023-04-14T09:29:01Z","timestamp":1681464541000},"page":"172-176","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with <scp>US FDA<\/scp> guideline"],"prefix":"10.1002","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3868-3372","authenticated-orcid":false,"given":"Kunihiro","family":"Iwamoto","sequence":"first","affiliation":[{"name":"Department of Psychiatry Graduate School of Medicine, Nagoya University  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuo","family":"Nakabayashi","sequence":"additional","affiliation":[{"name":"Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Graduate School of Medicine, Nagoya University  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Konishi","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Occupational and Environmental Health  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Momoe","family":"Saji","sequence":"additional","affiliation":[{"name":"Department of Neuropsychiatry Aichi Medical University  Nagakute Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reiji","family":"Yoshimura","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Occupational and Environmental Health  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kousuke","family":"Kanemoto","sequence":"additional","affiliation":[{"name":"Department of Neuropsychiatry Aichi Medical University  Nagakute Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirofumi","family":"Aoki","sequence":"additional","affiliation":[{"name":"Institute of Innovation for Future Society Nagoya University  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiko","family":"Ando","sequence":"additional","affiliation":[{"name":"Department of Advanced Medicine Nagoya University Hospital  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norio","family":"Ozaki","sequence":"additional","affiliation":[{"name":"Pathophysiology of Mental Disorders Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,4,14]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1017\/neu.2017.39"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/164_2018_169"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbr.2021.113507"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-020-0843-0"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(14)70314-1"},{"key":"e_1_2_11_7_1","first-page":"CD008016","article-title":"Maintenance treatment with antipsychotic drugs for schizophrenia","volume":"8","author":"Ceraso A","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_11_8_1","unstructured":"World Health Organization.Drug use and road safety: a policy brief.2016http:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/249533\/WHO\u2010MSD\u2010NVI\u20102016.01\u2010eng.pdf?sequence=1"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/13651501.2015.1089293"},{"key":"e_1_2_11_10_1","first-page":"21","article-title":"Actual driving behavior and daily cognitive function in patients with schizophrenia [in Japanese]","volume":"56","author":"Hoshino T","year":"2014","journal-title":"Psychiatry"},{"key":"e_1_2_11_11_1","doi-asserted-by":"crossref","unstructured":"KayGG LoganBK.Drugged Driving Expert Panel Report: A Consensus Protocol for Assessing the Potential of Drugs to Impair Driving.2011.","DOI":"10.1037\/e729092011-001"},{"key":"e_1_2_11_12_1","volume-title":"Evaluating drug effects on the ability to operate a motor vehicle","author":"U.S. Department of Health and Human Services","year":"2017"},{"key":"e_1_2_11_13_1","volume-title":"Guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle [in Japanese]. 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