{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:54:32Z","timestamp":1790931272155,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"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>Project Orbis, launched by the US FDA in 2019, enables collaboration among international regulatory agencies on cancer drug reviews. We assessed the regulatory impact of Project Orbis in Canada by analyzing publicly available data on marketing authorization applications (MAAs). We analyzed US\u2010Canada submission and approval gaps, time to regulatory decision, tumor areas, and sponsor involvement. From September 20, 2019 to the end of 2025, Health Canada approved 97 Orbis and 161 non\u2010Orbis oncology MAAs. Orbis MAAs had a shorter median submission gap than non\u2010Orbis MAAs, as well as a shorter median approval gap. Median time to decision was shorter for Orbis MAAs than non\u2010Orbis MAAs and was related to accelerated or standard review pathways. The time to decision was consistent with Health Canada's performance standards, and notably, Orbis type A median time to decision was similar for standard and priority review MAAs. Health Canada has been a highly active Project Orbis partner. Further research is needed to determine whether Orbis accelerates the overall time from regulatory filing to patient access to treatment, inclusive of health technology assessment and reimbursement negotiation processes.<\/jats:p>","DOI":"10.1002\/cpt.70503","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:20:22Z","timestamp":1790929222000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Measuring the Outcomes of International Oncology Regulatory Collaboration in Canada from 2019 to 2025: Project Orbis"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5319-6655","authenticated-orcid":false,"given":"Jonathan","family":"Zaslavsky","sequence":"first","affiliation":[{"name":"Regulatory Affairs, Scientific Affairs AstraZeneca Canada Inc.  Mississauga Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7764-9527","authenticated-orcid":false,"given":"David C.","family":"Sealey","sequence":"additional","affiliation":[{"name":"Regulatory Affairs, Scientific Affairs AstraZeneca Canada Inc.  Mississauga Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,2]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"crossref","first-page":"6412","DOI":"10.1158\/1078-0432.CCR-20-3292","article-title":"Project Orbis: global collaborative review program","volume":"26","author":"Claro R.A.","year":"2020","journal-title":"Clin. Cancer Res."},{"key":"e_1_2_11_2_1","unstructured":"Government of Canada.Project Orbis<https:\/\/www.canada.ca\/en\/health\u2010canada\/services\/drugs\u2010health\u2010products\/international\u2010activities\/project\u2010orbis.html> (2022). Accessed December 31 2025."},{"key":"e_1_2_11_3_1","unstructured":"US Food and Drug Administration.Project Orbis Frequently Asked Questions<https:\/\/www.fda.gov\/about\u2010fda\/oncology\u2010center\u2010excellence\/project\u2010orbis\u2010frequently\u2010asked\u2010questions> (2024)."},{"key":"e_1_2_11_4_1","doi-asserted-by":"crossref","first-page":"55","DOI":"10.22270\/ijdra.v12i3.699","article-title":"Index of application status transparency and availability of public information for Project Orbis agencies","volume":"12","author":"Lee S.H.","year":"2024","journal-title":"Int J Drug Reg Affairs"},{"key":"e_1_2_11_5_1","unstructured":"Government of Canada.Guidance Document: Management of Drug Submissions and Applications<https:\/\/www.canada.ca\/en\/health\u2010canada\/services\/drugs\u2010health\u2010products\/drug\u2010products\/applications\u2010submissions\/guidance\u2010documents\/management\u2010drug\u2010submissions\/industry.html> (2025)."},{"key":"e_1_2_11_6_1","unstructured":"Government of Canada.Guidance for Industry: Priority Review of Drug Submissions(2009)https:\/\/www.canada.ca\/en\/health\u2010canada\/services\/drugs\u2010health\u2010products\/drug\u2010products\/applications\u2010submissions\/guidance\u2010documents\/priority\u2010review\/drug\u2010submissions.html."},{"key":"e_1_2_11_7_1","unstructured":"Government of Canada.Guidance Document: Notice of Compliance with Conditions (NOC\/c)<https:\/\/www.canada.ca\/en\/health\u2010canada\/services\/drugs\u2010health\u2010products\/drug\u2010products\/applications\u2010submissions\/guidance\u2010documents\/notice\u2010compliance\u2010conditions.html> (2016)."},{"key":"e_1_2_11_8_1","volume-title":"R&D Briefing 97: Access Consortium and Project Orbis New Active Substance Approvals across Eight National Regulatory Authorities: A Five\u2010Year Comparative Study","author":"Centre for Innovation in Regulatory Science","year":"2025"},{"key":"e_1_2_11_9_1","doi-asserted-by":"crossref","first-page":"993","DOI":"10.1007\/s43441-025-00817-8","article-title":"Strengthening the use of international collaborative regulatory assessments and regulatory alignment \u2013 implications for global convergence","volume":"59","author":"Skerritt J.H.","year":"2025","journal-title":"Ther. Innov. Regul. Sci."},{"key":"e_1_2_11_10_1","doi-asserted-by":"crossref","first-page":"770","DOI":"10.1016\/S1470-2045(24)00158-X","article-title":"Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis","volume":"25","author":"Zosso\u2010Pavic M.","year":"2024","journal-title":"Lancet Oncol."},{"key":"e_1_2_11_11_1","doi-asserted-by":"crossref","first-page":"e150","DOI":"10.1016\/S1470-2045(22)00701-X","article-title":"From the European medicines agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit","volume":"24","author":"Lythgoe M.P.","year":"2023","journal-title":"Lancet Oncol."},{"key":"e_1_2_11_12_1","unstructured":"Government of Canada.Drug and Health Product Submissions Under Review (SUR)<https:\/\/www.canada.ca\/en\/health\u2010canada\/services\/drug\u2010health\u2010product\u2010review\u2010approval\/submissions\u2010under\u2010review.html> (2026)."},{"key":"e_1_2_11_13_1","unstructured":"Government of Canada.Notice of Compliance Search<https:\/\/health\u2010products.canada.ca\/noc\u2010ac\/?lang=eng>."},{"key":"e_1_2_11_14_1","unstructured":"Government of Canada.Drug and Health Product Portal<https:\/\/dhpp.hpfb\u2010dgpsa.ca\/review\u2010documents>."},{"key":"e_1_2_11_15_1","unstructured":"US Food and Drug Administration.Project Orbis<https:\/\/www.fda.gov\/about\u2010fda\/oncology\u2010center\u2010excellence\/project\u2010orbis> (2026)."},{"key":"e_1_2_11_16_1","unstructured":"US Food and Drug Administration.Drugs@FDA: FDA\u2010Approved Drugs<https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm>."},{"key":"e_1_2_11_17_1","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2020-047557","article-title":"Time to market for drugs approved in Canada between 2014 and 2018: an observational study","volume":"11","author":"Lexchin J.","year":"2021","journal-title":"BMJ Open"},{"key":"e_1_2_11_18_1","doi-asserted-by":"crossref","first-page":"5599","DOI":"10.3390\/curroncol31090414","article-title":"Is Canada moving towards a more agile regulatory approval and reimbursement process with a shifting role for real\u2010world evidence (RWE) for oncology drugs?","volume":"31","author":"Lau C.Y.","year":"2024","journal-title":"Curr Oncol"},{"key":"e_1_2_11_19_1","doi-asserted-by":"crossref","first-page":"979","DOI":"10.1016\/S1470-2045(24)00286-9","article-title":"Clinical benefit, reimbursement outcomes, and prices of FDA\u2010approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis","volume":"25","author":"Jenei K.","year":"2024","journal-title":"Lancet Oncol."},{"key":"e_1_2_11_20_1","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcpo.2025.100635","article-title":"Therapeutic value of oncology drugs approved by Health Canada through Project Orbis: a cross\u2010sectional study","volume":"46","author":"Lexchin J.","year":"2025","journal-title":"J. Cancer Policy"},{"key":"e_1_2_11_21_1","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1016\/S1470-2045(22)00377-1","article-title":"Project Orbis: the UK experience after 1 year","volume":"23","author":"Lythgoe M.P.","year":"2022","journal-title":"Lancet Oncol."},{"key":"e_1_2_11_22_1","unstructured":"The Conference Board of Canada.Access and Time to Patient \u2013 Prescription Drugs in CanadaData briefing <https:\/\/www.signal49.ca\/wp\u2010content\/uploads\/2022\/10\/access\u2010and\u2010time\u2010to\u2010patient_jan2024.pdf> (2024)."},{"key":"e_1_2_11_23_1","unstructured":"Government of Ontario.Funding Accelerated for Specific Treatments (FAST) pilot program<https:\/\/www.ontario.ca\/page\/funding\u2010accelerated\u2010specific\u2010treatments\u2010fast\u2010pilot\u2010program>. Accessed December 31 2025."},{"key":"e_1_2_11_24_1","unstructured":"Pan\u2010Canadian Pharmaceutical Alliance.Early Negotiation Process (ENP)<https:\/\/www.pcpacanada.ca\/enp\u2010pathway>. Accessed December 31 2025."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70503","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70503","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70503","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:20:25Z","timestamp":1790929225000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70503"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,2]]},"references-count":24,"alternative-id":["10.1002\/cpt.70503"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70503","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,2]]},"assertion":[{"value":"2026-04-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"cpt.70503"}}