{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T14:51:18Z","timestamp":1786114278260,"version":"build-2736575974"},"reference-count":7,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:00:00Z","timestamp":1783036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:00:00Z","timestamp":1783036800000},"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":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:p>A new guideline clarifying basic principles for conducting a phase 1 trial in Japanese prior to multi\u2010regional clinical trials was issued in December 2023 to streamline global drug development and accelerate access to novel drugs. To foster a shared understanding of the guideline and discuss future pathways, the regulatory agency and industry jointly organized a public symposium. This report summarizes the proceedings of the symposium.<\/jats:p>","DOI":"10.1002\/cpt.70383","type":"journal-article","created":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T07:04:37Z","timestamp":1783062277000},"page":"594-597","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Symposium Report: Stakeholders' Perspectives on Phase 1 Trials in Japanese Prior to Multi\u2010Regional Clinical Trials and Future Pathways"],"prefix":"10.1002","volume":"120","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-3986-9700","authenticated-orcid":false,"given":"Yosuke","family":"Kobayashi","sequence":"first","affiliation":[{"name":"Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6967-6741","authenticated-orcid":false,"given":"Nobuko","family":"Matsushima","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson J&amp;J Innovative Medicine  Tokyo Japan"},{"name":"Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriyuki","family":"Takai","sequence":"additional","affiliation":[{"name":"EPS Corporation  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0454-4427","authenticated-orcid":false,"given":"Daisuke","family":"Sato","sequence":"additional","affiliation":[{"name":"Ministry of Health, Labour and Welfare  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1442-3251","authenticated-orcid":false,"given":"Shinichiro","family":"Hoshino","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K.  Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0438-4809","authenticated-orcid":false,"given":"Akihiro","family":"Ishiguro","sequence":"additional","affiliation":[{"name":"Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuo","family":"Iimura","sequence":"additional","affiliation":[{"name":"Pharmaceuticals and Medical Devices Agency  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,3]]},"reference":[{"key":"e_1_2_11_1_1","unstructured":"International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.ICH E17 General Principles for planning and design of Multi\u2010Regional Clinical Trials(2017)."},{"key":"e_1_2_11_2_1","unstructured":"Ministry of Health Labour and Welfare.Basic principles on Global Clinical Trials Notification No. 0928010<https:\/\/www.pmda.go.jp\/files\/000153265.pdf> (2007). Accessed March 11 2026."},{"key":"e_1_2_11_3_1","unstructured":"Sato D.The Background and Content of the NotificationPresented at Symposium on \u201cBasic principles for conductin phase 1 studies in Japanese prior to initiating multi\u2010regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan\u201d; August 4 2025 <https:\/\/www.pmda.go.jp\/files\/000276890.pdf> (2025). Accessed March 11 2026."},{"key":"e_1_2_11_4_1","unstructured":"Ministry of Health Labour and Welfare.Basic principles for conducting phase 1 studies in Japanese prior to initiating multi\u2010regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan. PSB\/PED Notification No. 1225\u20102. December 25 2023. <https:\/\/www.pmda.go.jp\/files\/000266727.pdf> (2023). Accessed March 11 2026."},{"key":"e_1_2_11_5_1","unstructured":"Ministry of Health Labour and Welfare.Q&A for basic principles for conducting phase 1 studies in Japanese prior to initiating multi\u2010regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan. Administrative Notice. December 25 2023 <https:\/\/www.pmda.go.jp\/files\/000266728.pdf> (2023). Accessed 11\u00a0March 2026."},{"key":"e_1_2_11_6_1","unstructured":"National Cancer Center Japan.Empowered National Synergy for Medical\u00a0Biotech Landscape Expansion across Japan (ENSEMBLExJ) project<https:\/\/www.ncc.go.jp\/en\/ri\/division\/vspo\/index.html> (2026). Accessed March 11 2026."},{"key":"e_1_2_11_7_1","unstructured":"Pharmaceuticals and Medical Devices Agency.PMDA Washington D.C. Office General Consultation Service<https:\/\/www.pmda.go.jp\/english\/int\u2010activities\/overseas\u2010office\/dc\/0002.html> (2025). Accessed 11 March 2026."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70383","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70383","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70383","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T20:35:35Z","timestamp":1785962135000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70383"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,3]]},"references-count":7,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/cpt.70383"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70383","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,3]]},"assertion":[{"value":"2026-03-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}