{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T12:27:41Z","timestamp":1786624061595,"version":"build-2736575974"},"reference-count":17,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"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"],"abstract":"<jats:p>Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European\u2010wide survey was conducted to solicit stakeholder perspectives on the priority areas for regulatory science research related to the use of artificial intelligence in the medicine lifecycle. Twenty\u2010eight regulatory science research questions were developed covering seven thematic domains: (1) research integrity and intellectual property; (2) accuracy and reliability of AI tools; (3) data governance, confidentiality, and consent; (4) regulation and oversight; (5) ethics, fairness, and bias prevention; (6) resources and support for AI use; and (7) impact on jobs and skills. Within each domain, stakeholders ranked four research challenges. A total of 273 responses were collected from regulators, pharmaceutical industry professionals, patients and consumers, academics, and healthcare professionals. Rankings of research challenges frequently converged across stakeholder groups and levels of AI experience. The top\u2010ranked research questions within each domain were weighted according to the overall importance ranking of each domain to identify a list of 10 priority areas of research. The majority of the 10 priority areas fell within the domains of \u201cAccuracy and reliability of AI tools,\u201d \u201cData governance, confidentiality, and consent,\u201d and \u201cEthics, fairness, and bias prevention.\u201d This list aims to support researchers and research funding bodies in addressing knowledge gaps on artificial intelligence in the medicines lifecycle.<\/jats:p>","DOI":"10.1002\/cpt.70400","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T11:31:11Z","timestamp":1786620671000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Regulatory Research Priorities for\n                    <scp>AI<\/scp>\n                    Use in the Medicine Lifecycle: A European Perspective with Global Relevance"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6253-7175","authenticated-orcid":false,"given":"Luis C.","family":"Pinheiro","sequence":"first","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0180-5340","authenticated-orcid":false,"given":"Amanda C.","family":"Langston","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Orre","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"The Dental and Pharmaceutical Benefits Agency  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joerg","family":"Zinserling","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"Federal Institute for Drugs and Medical Devices  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantina","family":"Boumaki","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"European Patients' Forum  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bastian V. H.","family":"Hornung","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"Medicines Evaluation Board  Utrecht The Netherlands"},{"name":"Julius Center for Health Sciences and Primary Care University Medical Centre Utrecht  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siobhan","family":"O'Sullivan","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"Royal College of Surgeons of Ireland  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9402-772X","authenticated-orcid":false,"given":"Gabriel","family":"Westman","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"Swedish Medical Products Agency  Uppsala Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl","family":"Broich","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"Federal Institute for Drugs and Medical Devices  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Arlett","sequence":"additional","affiliation":[{"name":"European Medicines Agency  Amsterdam The Netherlands"},{"name":"London School of Hygiene and Tropical Medicine  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,13]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1038\/s41591-024-03434-4","article-title":"Artificial intelligence in drug development","volume":"31","author":"Zhang K.","year":"2025","journal-title":"Nat. Med."},{"key":"e_1_2_12_2_1","doi-asserted-by":"crossref","DOI":"10.1016\/j.ejps.2024.106938","article-title":"Artificial intelligence\u2010driven pharmaceutical industry: a paradigm shift in drug discovery, formulation development, manufacturing, quality control, and post\u2010market surveillance","volume":"203","author":"Huanbutta K.","year":"2024","journal-title":"Eur. J. Pharm. Sci."},{"key":"e_1_2_12_3_1","volume-title":"Explanatory Memorandum on the updated OECD definition of an AI system: OECD Artificial Intelligence Papers [Internet]","year":"2024"},{"key":"e_1_2_12_4_1","doi-asserted-by":"crossref","first-page":"1392","DOI":"10.1002\/cpt.70107","article-title":"A fast path from innovation to safe and effective medicines","volume":"118","author":"Arlett P.","year":"2025","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_2_12_5_1","doi-asserted-by":"crossref","first-page":"1315","DOI":"10.1007\/s11030-021-10217-3","article-title":"Artificial intelligence to deep learning: machine intelligence approach for drug discovery","volume":"25","author":"Gupta R.","year":"2021","journal-title":"Mol. Divers."},{"key":"e_1_2_12_6_1","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1038\/s43856-025-00910-x","article-title":"Regulating the AI\u2010enabled ecosystem for human therapeutics","volume":"5","author":"Singh R.","year":"2025","journal-title":"Commun. Med."},{"key":"e_1_2_12_7_1","doi-asserted-by":"crossref","first-page":"1074","DOI":"10.1007\/s43441-025-00803-0","article-title":"The adoption and use of artificial intelligence and machine learning in clinical development","volume":"59","author":"Lamberti M.J.","year":"2025","journal-title":"Ther. Innov. Regul. Sci."},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.14740\/aicm8"},{"key":"e_1_2_12_9_1","volume-title":"Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle","year":"2024"},{"key":"e_1_2_12_10_1","volume-title":"Regulatory Science Strategy to 2025","year":"2020"},{"key":"e_1_2_12_11_1","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1007\/s12553-023-00738-2","article-title":"Artificial intelligence applied to clinical trials: opportunities and challenges","volume":"13","author":"Askin S.","year":"2023","journal-title":"Health Technol."},{"key":"e_1_2_12_12_1","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1016\/j.tips.2019.05.005","article-title":"Artificial intelligence for clinical trial design","volume":"40","author":"Harrer S.","year":"2019","journal-title":"Trends Pharmacol. 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Med."},{"key":"e_1_2_12_16_1","unstructured":"EU Survey<https:\/\/ec.europa.eu\/eusurvey\/home\/welcome> (2025)."},{"key":"e_1_2_12_17_1","unstructured":"Regulation (EU) 2024\/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300\/2008 (EU) No 167\/2013 (EU) No 168\/2013 (EU) 2018\/858 (EU) 2018\/1139 and (EU) 2019\/2144 and Directives 2014\/90\/EU (EU) 2016\/797 and (EU) 2020\/1828 (Artificial Intelligence Act)<https:\/\/eur\u2010lex.europa.eu\/eli\/reg\/2024\/1689\/oj\/eng>."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70400","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70400","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70400","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T11:31:15Z","timestamp":1786620675000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70400"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,13]]},"references-count":17,"alternative-id":["10.1002\/cpt.70400"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70400","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,13]]},"assertion":[{"value":"2026-03-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-29","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"cpt.70400"}}