{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T07:18:58Z","timestamp":1783667938704,"version":"3.55.0"},"reference-count":34,"publisher":"International Society of Global Health","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Glob Health"],"DOI":"10.7189\/jogh.16.04145","type":"journal-article","created":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T07:08:28Z","timestamp":1783667308000},"source":"Crossref","is-referenced-by-count":0,"title":["Global disparities in regulatory approval of prophylactic vaccines, 2005\u20132024"],"prefix":"10.7189","volume":"16","author":[{"given":"Rizhen","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Global Health, School of Public Health, Peking University, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China"},{"name":"International Research Centre for Medicinal Administration, Peking University, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangmu","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Global Health, School of Public Health, Peking University, Beijing, China"},{"name":"Institute for Global Health and Development, Peking University, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Global Health, School of Public Health, Peking University, Beijing, China"},{"name":"Institute for Global Health and Development, Peking University, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"4223","published-online":{"date-parts":[[2026,7,10]]},"reference":[{"key":"key-10.7189\/jogh.16.04145-202607090917-R1","doi-asserted-by":"publisher","first-page":"3389","DOI":"10.1016\/j.vaccine.2018.03.049","article-title":"Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.","volume":"36","author":"Dellepiane","year":"2018","journal-title":"Vaccine"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R2","unstructured":"IQVIA Inc. World Health Organization Prequalification of Vaccines. 2017. Available: https:\/\/www.iqvia.com\/library\/white-papers\/world-health-organization-prequalification-of-vaccines. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R3","doi-asserted-by":"publisher","first-page":"S428","DOI":"10.1093\/cid\/civ491","article-title":"Regulatory pathways that facilitated timely registration of a new group A meningococcal conjugate vaccine for Africa\u2019s meningitis belt countries.","volume":"61","author":"Dellepiane","year":"2015","journal-title":"Clin Infect Dis"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R4","doi-asserted-by":"publisher","first-page":"e3","DOI":"10.1056\/NEJMp2202669","article-title":"Delivering Pandemic Vaccines in 100 Days - What Will It Take?","volume":"387","author":"Saville","year":"2022","journal-title":"N Engl J Med"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R5","doi-asserted-by":"publisher","first-page":"e1132","DOI":"10.1016\/S2214-109X(25)00062-2","article-title":"Development, launch, and scale-up of health products in low-income and middle-income countries: a retrospective analysis on 59 health products.","volume":"13","author":"Mao","year":"2025","journal-title":"Lancet Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R6","doi-asserted-by":"publisher","first-page":"e012883","DOI":"10.1136\/bmjgh-2023-012883","article-title":"Strengthening regulatory systems globally: a crucial step towards pandemic preparedness and response.","volume":"8","author":"Mukherjee","year":"2023","journal-title":"BMJ Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R7","doi-asserted-by":"publisher","first-page":"1023","DOI":"10.1016\/S0140-6736(21)00306-8","article-title":"Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment.","volume":"397","author":"Wouters","year":"2021","journal-title":"Lancet"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R8","doi-asserted-by":"publisher","first-page":"e005032","DOI":"10.1136\/bmjgh-2021-005032","article-title":"Assessing vaccine introduction and uptake timelines in Gavi-supported countries: are introduction timelines accelerating across vaccine delivery platforms?","volume":"6","author":"Luthra","year":"2021","journal-title":"BMJ Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R9","doi-asserted-by":"publisher","first-page":"2334","DOI":"10.1016\/S0140-6736(21)01220-4","article-title":"Delayed COVID-19 vaccine roll-out in Japan.","volume":"397","author":"Kosaka","year":"2021","journal-title":"Lancet"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R10","doi-asserted-by":"publisher","first-page":"e012855","DOI":"10.1136\/bmjgh-2023-012855","article-title":"Comparing research and development, launch, and scale up timelines of 18 vaccines: lessons learnt from COVID-19 and implications for other infectious diseases.","volume":"8","author":"Mao","year":"2023","journal-title":"BMJ Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R11","unstructured":"European Medicines Agency. Authorisation of medicines. 2024. Available: https:\/\/www.ema.europa.eu\/en\/about-us\/what-we-do\/authorisation-medicines. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R12","unstructured":"Citeline. Pharmaprojects. 2025. Available: https:\/\/www.citeline.com\/en\/products-services\/clinical\/pharmaprojects. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R13","unstructured":"World Health Organization. Global vaccine market report 2024. 2024. Available: https:\/\/www.who.int\/publications\/m\/item\/global-vaccine-market-report-2024. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R14","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1016\/j.ctrv.2016.10.009","article-title":"Factors associated with failure of oncology drugs in late-stage clinical development: A systematic review.","volume":"52","author":"Jardim","year":"2017","journal-title":"Cancer Treat Rev"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R15","doi-asserted-by":"publisher","first-page":"e015700","DOI":"10.1136\/bmjgh-2024-015700","article-title":"Disparities in availability of new cancer drugs worldwide: 1990-2022.","volume":"9","author":"Li","year":"2024","journal-title":"BMJ Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R16","unstructured":"YAOZHI database. 2025. Available: https:\/\/db.yaozh.com. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R17","unstructured":"Basta NE, Moodie EMM. VIPER group COVID-19 Vaccine Development and Approvals Tracker Team. COVID-19 Vaccine Development and Approvals Tracker. 2020. Available: https:\/\/covid19.trackvaccines.org\/vaccines\/approved\/. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R18","doi-asserted-by":"publisher","first-page":"1453","DOI":"10.1016\/S0140-6736(07)61602-X","article-title":"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.","volume":"370","author":"von Elm","year":"2007","journal-title":"Lancet"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R19","unstructured":"Elm Ev, Altman D, Egger M, Pocock S, G\u00f8tzsche P, Vandenbroucke J, et al. The STROBE reporting checklist. 2025. Available: https:\/\/www.equator-network.org\/reporting-guidelines\/strobe\/. Accessed:25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R20","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1038\/s41590-017-0007-9","article-title":"Emerging viral diseases from a vaccinology perspective: preparing for the next pandemic.","volume":"19","author":"Graham","year":"2018","journal-title":"Nat Immunol"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R21","doi-asserted-by":"publisher","first-page":"e217075","DOI":"10.1001\/jamanetworkopen.2021.7075","article-title":"Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs.","volume":"4","author":"Miller","year":"2021","journal-title":"JAMA Netw Open"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R22","unstructured":"European Medicines Agency. Marketing authorisation. Available: https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R23","doi-asserted-by":"publisher","first-page":"1826","DOI":"10.1001\/jamainternmed.2016.6008","article-title":"Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results.","volume":"176","author":"Hwang","year":"2016","journal-title":"JAMA Intern Med"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R24","doi-asserted-by":"publisher","first-page":"326","DOI":"10.7326\/M20-5350","article-title":"Probability of success and timelines for the development of vaccines for emerging and reemerged viral infectious diseases.","volume":"174","author":"MacPherson","year":"2021","journal-title":"Ann Intern Med"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R25","doi-asserted-by":"publisher","first-page":"e1059","DOI":"10.1016\/S2214-109X(24)00092-5","article-title":"Facilitating the development of urgently required combination vaccines.","volume":"12","author":"Hausdorff","year":"2024","journal-title":"Lancet Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R26","unstructured":"Pharmashots. Top 20 Biopharma Companies of 2025. 2025. Available: https:\/\/pharmashots.com\/20953\/top-20-biopharma-companies-of-2025\/. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R27","unstructured":"Institute for Health Metrics and Evaluation. GBD results tool. 2021. Available: http:\/\/ghdx.healthdata.org\/gbd-results-tool Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R28","doi-asserted-by":"publisher","first-page":"e1658","DOI":"10.1016\/S2214-109X(23)00328-5","article-title":"From private incentives to public health need: rethinking research and development for pandemic preparedness.","volume":"11","author":"Torreele","year":"2023","journal-title":"Lancet Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R29","unstructured":"Center for Asia-Pacific Resilience and Innovation. Resilience in the Asia Pacific: Vaccines and the \u201cTriple Challenge\u201d. 2021. Available: https:\/\/caprifoundation.org\/zh-hant\/resilience-in-the-asia-pacific-vaccines-and-the-triple-challenge\/. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R30","unstructured":"United States Pharmacopeia. Expanding the capacity to produce vaccines in Africa. Rockville, Maryland, USA: United States Pharmacopeial Convention; 2023. Available: https:\/\/www.usp.org\/sites\/default\/files\/usp\/document\/our-work\/global-public-health\/vaccine-manufacturing-in-africa_white-paper_feb-2023.pdf. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R31","unstructured":"World Health Organization. Towards Access 2030 - WHO Medicines and Health Products Programme Strategic. 2017. Available: https:\/\/www.who.int\/publications\/i\/item\/WHOEMP2017.01. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R32","doi-asserted-by":"publisher","first-page":"e769","DOI":"10.1016\/S2214-109X(24)00515-1","article-title":"A roadmap for fostering timely regulatory and ethics approvals of international clinical trials in support of global health research systems.","volume":"13","author":"Cavaleri","year":"2025","journal-title":"Lancet Glob Health"},{"key":"key-10.7189\/jogh.16.04145-202607090917-R33","unstructured":"World Health Organization Regional Office for the Western Pacific. Western Pacific regional action agenda on regulatory strengthening, convergence and cooperation for medicines and the health workforce. 2020. Available: https:\/\/www.who.int\/publications\/i\/item\/9789290618942. Accessed: 25 June 2025."},{"key":"key-10.7189\/jogh.16.04145-202607090917-R34","doi-asserted-by":"publisher","first-page":"100983","DOI":"10.1016\/j.lanepe.2024.100983","article-title":"Factors associated with acceleration of clinical development for infectious diseases: a cross-sectional analysis of 10-year EMA registration data.","volume":"43","author":"de Jong","year":"2024","journal-title":"Lancet Reg Health Eur"}],"container-title":["Journal of Global Health"],"original-title":[],"link":[{"URL":"https:\/\/jogh.org\/2026\/jogh-16-04145","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T07:08:30Z","timestamp":1783667310000},"score":1,"resource":{"primary":{"URL":"https:\/\/jogh.org\/2026\/jogh-16-04145"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,10]]},"references-count":34,"URL":"https:\/\/doi.org\/10.7189\/jogh.16.04145","relation":{},"ISSN":["2047-2978","2047-2986"],"issn-type":[{"value":"2047-2978","type":"print"},{"value":"2047-2986","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,10]]},"article-number":"04145"}}