{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T14:01:46Z","timestamp":1789740106728,"version":"4.0.1"},"reference-count":29,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"unspecified","delay-in-days":79,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Health Systems Research Initiative","award":["MR\/V02096X\/1"],"award-info":[{"award-number":["MR\/V02096X\/1"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["bmjph"],"accepted":{"date-parts":[[2026,8,20]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>E-pharmacies carry enormous potential to improve access to medicines but also introduce significant regulatory concerns. This research maps the regulatory approaches governing e-pharmacies across 12 countries and identifies gaps in their scope and comprehensiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Comparative review of regulatory documents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources<\/jats:title>\n                    <jats:p>Publicly accessible documents from governments, regulatory authorities and relevant national, subnational and supranational sources.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Eligibility criteria<\/jats:title>\n                    <jats:p>Countries (Brazil, Germany, Ghana, Indonesia, Ireland, Japan, Kenya, Singapore, South Africa, UAE, UK and USA) were purposively selected to capture geographic and regulatory diversity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data extraction and synthesis<\/jats:title>\n                    <jats:p>We extracted e-pharmacy-related regulatory text using a piloted tool, categorising identified requirements across 10 domains: licensure, accreditation, medicine sale, website content, data privacy, quality, operational oversight, advertising, penalties and other technological aspects. We also developed a 15-item subset of basic requirements and assessed regulatory comprehensiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>From 41 documents, we identified 43 regulatory requirements, with substantial country and regional variation in whether each was mandated, permitted, prohibited or unaddressed. Online sale of prescription medicines was explicitly permitted in 8 of 12 countries, but prohibited in Ireland, Japan and UAE. Most countries (n=9) required e-pharmacies to be linked to a brick-and-mortar pharmacy. Four countries prohibited online sale of narcotics. Approaches for verifying website authenticity included displaying licence numbers (n=5) and using a \u2018common logo\u2019 (n=5). Fewer regulations addressed newer technological developments, including mobile apps (n=2) and social media (n=1). Kenya and the UK met all requirements on our 15-item checklist, indicating higher comprehensiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>We identified substantial variation in how e-pharmacy regulations addressed the 10 regulatory domains, particularly licensure, medicine sale and website authenticity. Gaps in regulatory coverage were most evident for accreditation, penalties and integration with broader digital health systems. This review offers a practical checklist of basic regulatory requirements to help policymakers strengthen e-pharmacy governance and ensure safe access to medicines online.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjph-2025-004309","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T13:05:23Z","timestamp":1789736723000},"page":"e004309","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Variation and gaps in online pharmacy regulation: a comparative review of regulations across 12 countries"],"prefix":"10.1136","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2211-145X","authenticated-orcid":false,"given":"Gautam","family":"Satheesh","sequence":"first","affiliation":[{"name":"The George Institute for Global Health India, Hyderabad, India"},{"name":"University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1751-3817","authenticated-orcid":false,"given":"Krishna","family":"Nandakumar","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health India, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3775-4415","authenticated-orcid":false,"given":"Benjamin","family":"Palafox","sequence":"additional","affiliation":[{"name":"Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0332-8154","authenticated-orcid":false,"given":"Jaison","family":"Joseph","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health India, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0085-8878","authenticated-orcid":false,"given":"Sushree Nibedita","family":"Panda","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health India, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devaki","family":"Nambiar","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health India, New Delhi, India"},{"name":"Faculty of Medicine, UNSW Sydney, Sydney, New South Wales, Australia"},{"name":"Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5870-7936","authenticated-orcid":false,"given":"Abdul","family":"Salam","sequence":"additional","affiliation":[{"name":"Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India"},{"name":"The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6861-0601","authenticated-orcid":false,"given":"Sammy","family":"Masibo","sequence":"additional","affiliation":[{"name":"Prism Centre, Strathmore University Business School, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5761-6151","authenticated-orcid":false,"given":"Francis P N","family":"Wafula","sequence":"additional","affiliation":[{"name":"Prism Centre, Strathmore University Business School, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria-Belen","family":"Tarrafeta-Sayas","sequence":"additional","affiliation":[{"name":"Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7765-2443","authenticated-orcid":false,"given":"Raffaella","family":"Ravinetto","sequence":"additional","affiliation":[{"name":"Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium"},{"name":"School of Public Health, University of the Western Cape, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2241-3485","authenticated-orcid":false,"given":"Catherine","family":"Goodman","sequence":"additional","affiliation":[{"name":"Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,18]]},"reference":[{"key":"2026091806051790000_4.3.e004309.1","unstructured":"Future Market Insights . 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The hague, the Netherlands: international pharmaceutical federation. online pharmacy operations and distribution of medicines. 2021. Available: https:\/\/www.fip.org\/file\/5082 [Accessed 1 Apr 2025]."},{"key":"2026091806051790000_4.3.e004309.6","unstructured":"Afuye S , Uka J , Lawal D , et al . Advancing access to essential health products via online pharmacies in africa: regulatory landscaping report. Vancouver (BC): Salient Advisory; 2023. 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The internet pharmacy market in 2016: trends, challenges, and opportunities. Washington, DC, USA: Center for Safe Internet Pharmacies; 2016. Available: http:\/\/safemedsonline.org\/wp-content\/uploads\/2016\/01\/The-Internet-Pharmacy-Market-in-2016.pdf [Accessed 9 Oct 2024]."},{"key":"2026091806051790000_4.3.e004309.11","doi-asserted-by":"crossref","DOI":"10.1186\/s13011-020-00261-x","article-title":"Compliance of private pharmacies in Uganda with controlled prescription drugs regulations: a mixed-methods study","volume":"15","author":"Kamba","year":"2020","journal-title":"Subst Abuse Treat Prev Policy"},{"key":"2026091806051790000_4.3.e004309.12","doi-asserted-by":"publisher","DOI":"10.1093\/heapol\/czw007"},{"key":"2026091806051790000_4.3.e004309.13","unstructured":"Visa Inc . Online pharmacy guide for acquirers. San Francisco: Visa Inc; 2016. 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