{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T10:19:25Z","timestamp":1787566765804,"version":"build-2736575974"},"reference-count":35,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T00:00:00Z","timestamp":1784073600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","thelancet.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["eClinicalMedicine"],"published-print":{"date-parts":[[2026,8]]},"DOI":"10.1016\/j.eclinm.2026.104121","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T17:28:26Z","timestamp":1786037306000},"page":"104121","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets"],"prefix":"10.1016","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-6071-4863","authenticated-orcid":false,"given":"Zhihao","family":"Xu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3635-5212","authenticated-orcid":false,"given":"Kristina","family":"Jenei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6435-1825","authenticated-orcid":false,"given":"Richard","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.eclinm.2026.104121_bib1","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1038\/s41392-025-02267-y","article-title":"Current landscape of innovative drug development and regulatory support in China","volume":"10","author":"Tan","year":"2025","journal-title":"Signal Transduct Target Ther"},{"key":"10.1016\/j.eclinm.2026.104121_bib2","author":"Song"},{"issue":"11","key":"10.1016\/j.eclinm.2026.104121_bib4","doi-asserted-by":"crossref","first-page":"4266","DOI":"10.1016\/j.apsb.2022.08.021","article-title":"Drug discovery in China: a snapshot of recent progress","volume":"12","author":"Hu","year":"2022","journal-title":"Acta Pharm Sin B"},{"issue":"8","key":"10.1016\/j.eclinm.2026.104121_bib37","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1038\/d41573-026-00113-6","article-title":"Growth in clinical research capability in China and impact on the pharmaceutical sector","volume":"25","author":"Guo","year":"2026","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/j.eclinm.2026.104121_bib6","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2023.1296737","article-title":"Bridging the new drug access gap between China and the United States and its related policies","volume":"14","author":"Zhu","year":"2024","journal-title":"Front Pharmacol"},{"issue":"10","key":"10.1016\/j.eclinm.2026.104121_bib7","doi-asserted-by":"crossref","first-page":"e558","DOI":"10.1016\/S1470-2045(25)00350-X","article-title":"Challenges for Chinese innovative cancer drugs in going global: insights from multiregional clinical trials","volume":"26","author":"Du","year":"2025","journal-title":"Lancet Oncol"},{"issue":"2","key":"10.1016\/j.eclinm.2026.104121_bib8","doi-asserted-by":"crossref","first-page":"470","DOI":"10.1002\/cpt.70084","article-title":"Innovative drugs approved in China after registration classification reform: current status, disparities, and challenges","volume":"119","author":"Zhu","year":"2026","journal-title":"Clin Pharmacol Ther"},{"issue":"1","key":"10.1016\/j.eclinm.2026.104121_bib9","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1186\/s41256-024-00396-5","article-title":"Regulatory efforts to address the access gap for foreign new drugs in China: the priority review program and related policies","volume":"10","author":"Zhu","year":"2025","journal-title":"Glob Health Res Policy"},{"issue":"11","key":"10.1016\/j.eclinm.2026.104121_bib10","first-page":"1235","article-title":"Comparative analysis of new drugs approved by the United States and China in 2023","volume":"38","author":"Ma","year":"2024","journal-title":"Chin Pharm Affairs"},{"issue":"6","key":"10.1016\/j.eclinm.2026.104121_bib11","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2022-069132","article-title":"Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006-2021: a cross-sectional study","volume":"13","author":"Xie","year":"2023","journal-title":"BMJ Open"},{"issue":"6","key":"10.1016\/j.eclinm.2026.104121_bib13","doi-asserted-by":"crossref","first-page":"1757","DOI":"10.1007\/s40123-024-00939-6","article-title":"Cost-effectiveness analysis of Fluocinolone Acetonide Intravitreal (FAI) implant for chronic noninfectious uveitis affecting the posterior segment of the eye (NIU-PS) in China","volume":"13","author":"Mao","year":"2024","journal-title":"Ophthalmol Ther"},{"key":"10.1016\/j.eclinm.2026.104121_bib14","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2023.1175310","article-title":"Economic evaluation of bailing capsules for patients with diabetic nephropathy in China","volume":"14","author":"He","year":"2023","journal-title":"Front Pharmacol"},{"key":"10.1016\/j.eclinm.2026.104121_bib15","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1007\/s00210-025-04412-4","article-title":"Comparison of drug approvals of the FDA and EMA between 2013 and 2023","volume":"399","author":"Lau","year":"2025","journal-title":"Naunyn-Schmiedebergs Arch Pharmacol"},{"issue":"1","key":"10.1016\/j.eclinm.2026.104121_bib16","doi-asserted-by":"crossref","first-page":"3325","DOI":"10.1038\/s41598-024-53554-7","article-title":"Analysis of US food and drug administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022","volume":"14","author":"Seoane-Vazquez","year":"2024","journal-title":"Sci Rep"},{"key":"10.1016\/j.eclinm.2026.104121_bib5","doi-asserted-by":"crossref","first-page":"2629","DOI":"10.2147\/DDDT.S514132","article-title":"New drug approvals in China: an international comparative analysis, 2019-2023","volume":"19","author":"Yan","year":"2025","journal-title":"Drug Des Devel Ther"},{"key":"10.1016\/j.eclinm.2026.104121_bib18","doi-asserted-by":"crossref","first-page":"6911","DOI":"10.1007\/s00210-025-04833-1","article-title":"Problems associated with the ATC system of drug classification","volume":"399","author":"Bindel","year":"2025","journal-title":"Naunyn-Schmiedebergs Arch Pharmacol"},{"key":"10.1016\/j.eclinm.2026.104121_bib19","doi-asserted-by":"crossref","first-page":"16334","DOI":"10.1038\/s41598-025-00192-2","article-title":"Trends in global and regional incidence and prevalence of hypertensive disorders in pregnancy (1990\u20132021): an age-period-cohort analysis","volume":"15","author":"Sun","year":"2025","journal-title":"Sci Rep"},{"issue":"12","key":"10.1016\/j.eclinm.2026.104121_bib20","doi-asserted-by":"crossref","first-page":"858","DOI":"10.1038\/nrd.2018.150","article-title":"Reforming China's drug regulatory system","volume":"17","author":"Xu","year":"2018","journal-title":"Nat Rev Drug Discov"},{"issue":"2","key":"10.1016\/j.eclinm.2026.104121_bib21","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1007\/s43441-022-00472-3","article-title":"Trends and characteristics of new drug approvals in China, 2011-2021","volume":"57","author":"Su","year":"2023","journal-title":"Ther Innov Regul Sci"},{"issue":"4","key":"10.1016\/j.eclinm.2026.104121_bib22","doi-asserted-by":"crossref","DOI":"10.1111\/jebm.70085","article-title":"Quality of drug clinical trials in China: a mixed methods research","volume":"18","author":"Chen","year":"2025","journal-title":"J Evid Based Med"},{"issue":"5","key":"10.1016\/j.eclinm.2026.104121_bib23","first-page":"417","article-title":"Research and reflection on the development of international regulatory harmonization of pharmaceutics","volume":"27","author":"Zhuangqi","year":"2024","journal-title":"Health Dev Policy Res"},{"issue":"1","key":"10.1016\/j.eclinm.2026.104121_bib24","doi-asserted-by":"crossref","DOI":"10.1080\/20016689.2023.2218633","article-title":"Access to innovative drugs and the national reimbursement drug list in China: changing dynamics and future trends in pricing and reimbursement","volume":"11","author":"Macabeo","year":"2023","journal-title":"J Mark Access Health Policy"},{"key":"10.1016\/j.eclinm.2026.104121_bib25","doi-asserted-by":"crossref","DOI":"10.3389\/fpubh.2025.1705030","article-title":"Impact of national drug price negotiation policy on the innovation performance of biopharmaceutical industry in China","volume":"13","author":"Zhu","year":"2025","journal-title":"Front Public Health"},{"key":"10.1016\/j.eclinm.2026.104121_bib26","article-title":"Use of real world data to improve drug coverage decisions in China","volume":"381","author":"Wang","year":"2023","journal-title":"BMJ"},{"key":"10.1016\/j.eclinm.2026.104121_bib27","doi-asserted-by":"crossref","DOI":"10.3389\/fpubh.2025.1662346","article-title":"Effect of the national reimbursement drug list negotiation policy on utilization of negotiated anticancer drugs in Chinese public hospital: a quasi-natural experiment","volume":"13","author":"Liu","year":"2025","journal-title":"Front Public Health"},{"issue":"1","key":"10.1016\/j.eclinm.2026.104121_bib28","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1186\/s12939-025-02390-w","article-title":"Impacts of national reimbursement drug price negotiation on drug accessibility, utilization, and cost in China: a systematic review","volume":"24","author":"Zhu","year":"2025","journal-title":"Int J Equity Health"},{"key":"10.1016\/j.eclinm.2026.104121_bib29","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1016\/j.pharp.2025.11.001","article-title":"Impact of China's drug innovation policy on patent quantity and quality: evidence from a representative chemical pharmaceutical enterprise","volume":"1","author":"Yuan","year":"2025","journal-title":"Pharmacoecon Policy"},{"issue":"11","key":"10.1016\/j.eclinm.2026.104121_bib30","doi-asserted-by":"crossref","first-page":"e515","DOI":"10.1016\/S1470-2045(22)00483-1","article-title":"Accelerating the integration of China into the global development of innovative anticancer drugs","volume":"23","author":"Huang","year":"2022","journal-title":"Lancet Oncol"},{"issue":"9","key":"10.1016\/j.eclinm.2026.104121_bib36","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1056\/NEJMp2505821","article-title":"The rise of drug innovation in China - implications for patient access in the United States and globally","volume":"393","author":"Vokinger","year":"2025","journal-title":"N Engl J Med"},{"issue":"10","key":"10.1016\/j.eclinm.2026.104121_bib31","first-page":"qxae124","article-title":"Biopharmaceutical pipeline funded by venture capital firms, 2014 to 2024","volume":"2","author":"Kang","year":"2024","journal-title":"Health Aff Sch"},{"issue":"17","key":"10.1016\/j.eclinm.2026.104121_bib32","doi-asserted-by":"crossref","first-page":"1471","DOI":"10.1001\/jama.2024.2396","article-title":"Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval","volume":"331","author":"Liu","year":"2024","journal-title":"JAMA"},{"issue":"10","key":"10.1016\/j.eclinm.2026.104121_bib33","doi-asserted-by":"crossref","first-page":"738","DOI":"10.1038\/d41573-025-00102-1","article-title":"The rise of China's pharmaceutical industry from 2015-2024: a decade of innovation","volume":"24","author":"Liu","year":"2025","journal-title":"Nat Rev Drug Discov"},{"issue":"6","key":"10.1016\/j.eclinm.2026.104121_bib34","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2022.16183","article-title":"Cancer therapy approval timings, review speed, and publication of pivotal registration trials in the US and Europe, 2010-2019","volume":"5","author":"Lythgoe","year":"2022","journal-title":"JAMA Netw Open"},{"issue":"1","key":"10.1016\/j.eclinm.2026.104121_bib35","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1038\/s41392-026-02606-7","article-title":"The evolving global landscape of first-in-class oncology drug innovation","volume":"11","author":"Mao","year":"2026","journal-title":"Signal Transduct Target Ther"},{"issue":"9","key":"10.1016\/j.eclinm.2026.104121_bib38","doi-asserted-by":"crossref","first-page":"1131","DOI":"10.1016\/S1470-2045(25)00361-4","article-title":"The importance of high-quality evidence supporting cancer drug approvals","volume":"26","author":"Vokinger","year":"2025","journal-title":"Lancet Oncol"}],"container-title":["eClinicalMedicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589537026003743?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589537026003743?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T08:25:45Z","timestamp":1787559945000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2589537026003743"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":35,"alternative-id":["S2589537026003743"],"URL":"https:\/\/doi.org\/10.1016\/j.eclinm.2026.104121","relation":{},"ISSN":["2589-5370"],"issn-type":[{"value":"2589-5370","type":"print"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets","name":"articletitle","label":"Article Title"},{"value":"eClinicalMedicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.eclinm.2026.104121","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}],"article-number":"104121"}}