{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:51:43Z","timestamp":1791233503904,"version":"4.1.0"},"reference-count":103,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T00:00:00Z","timestamp":1766448000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T00:00:00Z","timestamp":1766448000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Tropical Med Int Health"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Malaria is a major public health issue in East Africa, leading to widespread illness and fatalities, especially among vulnerable populations such as children under 5\u2009years of age and pregnant women. Artemisinin\u2010based combination therapies (ACTs) are the primary treatment modality; however, their efficacy is undermined by the prevalence of substandard ACTs and the increasing risk of resistance. Therefore, it is crucial to improve evidence on quality, therapeutic efficacy, and regulatory performance to promote malaria control efforts in the region.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This systematic review followed PRISMA 2020 guidelines, with the protocol registered in PROSPERO (CRD420251135109). Literature was searched in PubMed and Google Scholar databases from July to September 2025. Methodological quality was appraised using MEDQUARG and STROBE. Two reviewers independently extracted data, resolving discrepancies by consensus. The extracted findings were synthesised narratively to identify key trends.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A systematic review of 40 articles from Ethiopia, Kenya, Tanzania, and Uganda revealed considerable variation in the quality of Artemisinin\u2010based combination therapies (ACTs). Across the four East African countries, a total of 3363 ACT samples were tested, of which 375 failed to comply with specification limits set for at least one physicochemical quality parameter. This corresponds to an overall failure rate of 11.2% (375\/3363). Country\u2010specific failure rates reflect the highest rate in Uganda (33.3% [16\/48]), followed by Kenya (14.1% [10\/71]), Tanzania (11.6% [333\/2859]), and Ethiopia (4.2% [16\/385]). This considerable variation could be attributed to the differences in prevalence, the number of studies conducted, study design, and sampling methodology. The reported poor quality of ACTs, major treatment options in managing malaria cases, could pose a public health threat. Though the studies conducted so far may not give a real picture of the magnitude of poor quality ACTs medicines and their impact on the treatment outcomes, the reports indicated that ACTs remain highly efficacious, with most therapeutic trials reporting polymerase chain reaction\u2010corrected cure rates of \u2265\u200990%. As indicated in the literature, Artemether\u2010lumefantrine consistently demonstrated strong treatment outcomes, while dihydroartemisinin\u2010piperaquine provided extended prophylactic effects. However, emerging Plasmodium falciparum resistance, particularly K13 mutations associated with delayed parasite clearance, poses an ongoing threat to ACT effectiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The findings of this study revealed that 11.2% of ACTs samples were found to be poor quality. The clinical data reflects that in East Africa, ACTs remain effective despite the prevalence of substandard and falsified ACTs and emerging resistance threatening long\u2010term gains. Thus, strengthening regional regulatory harmonization, pharmacovigilance, molecular surveillance, and local manufacturing capacity is essential to combat resistance of ACT and ensure equitable access to quality\u2010assured therapies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/tmi.70072","type":"journal-article","created":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T00:15:18Z","timestamp":1766535318000},"page":"254-273","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Artemisinin\u2010Based Combination Therapies in East Africa: A Systematic Review of Quality, Clinical Efficacy, and Regulatory Progress Towards Sustainable Malaria Control"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2225-7088","authenticated-orcid":false,"given":"Yesuneh Tefera","family":"Mekasha","sequence":"first","affiliation":[{"name":"Department of Veterinary Pharmacy Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar  Gondar Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3855-7213","authenticated-orcid":false,"given":"Addisu Afrassa","family":"Tegegne","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry College of Medicine and Health Sciences, University of Gondar  Gondar Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tapfumanei","family":"Mashe","sequence":"additional","affiliation":[{"name":"Health Systems Strengthening, World Health Organization  Harare Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Million","family":"Girma","sequence":"additional","affiliation":[{"name":"School of Pharmacy College of Medicine and Health Sciences, Wolaita Sodo University  Wolaita Sodo Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1693-0240","authenticated-orcid":false,"given":"Gemmechu","family":"Hasen","sequence":"additional","affiliation":[{"name":"Clinical Trail Directorate Armauer Hansen Research Institute  Addis Ababa Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sileshi","family":"Belew","sequence":"additional","affiliation":[{"name":"Clinical Trail Directorate Armauer Hansen Research Institute  Addis Ababa Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,23]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s44197\u2010024\u201000228\u20102"},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/23744235.2021.2022195"},{"key":"e_1_2_15_4_1","doi-asserted-by":"crossref","unstructured":"\u201cWHO Guidelines for Malaria \u201d30 November 2024 World Health Organization (2024) https:\/\/doi.org\/10.2471\/b09146.","DOI":"10.2471\/B09146"},{"key":"e_1_2_15_5_1","unstructured":"WHO \u201cMalaria Report \u201dhttps:\/\/www.who.int\/teams\/global\u2010malaria\u2010programme\/reports\/world\u2010malaria\u2010report\u20102023."},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010025\u201005492\u20106"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2211803"},{"key":"e_1_2_15_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010018\u20102607\u20108"},{"key":"e_1_2_15_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/1748\u20105908\u20107\u201018"},{"key":"e_1_2_15_10_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.14\u20100031"},{"key":"e_1_2_15_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/adtp.202400453"},{"key":"e_1_2_15_12_1","volume-title":"Guidelines for the Treatment of Malaria","author":"World Health Organisation","year":"2006"},{"key":"e_1_2_15_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41564\u2010023\u201001461\u20104"},{"key":"e_1_2_15_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43856-025-01008-0"},{"key":"e_1_2_15_15_1","unstructured":"WHO \u201cMalaria Policy Advisory Group (MPAG) Meeting Report of 4 5 and 7 \u201d2024."},{"key":"e_1_2_15_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2210956"},{"key":"e_1_2_15_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2101746"},{"key":"e_1_2_15_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-1005-2"},{"key":"e_1_2_15_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/mec.15706"},{"key":"e_1_2_15_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010023\u201002551\u2010w"},{"key":"e_1_2_15_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(12)70064-6"},{"key":"e_1_2_15_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475\u20102875\u201010\u2010352"},{"key":"e_1_2_15_23_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0248057"},{"key":"e_1_2_15_24_1","doi-asserted-by":"publisher","DOI":"10.21315\/mjps2022.20.1.1"},{"key":"e_1_2_15_25_1","doi-asserted-by":"publisher","DOI":"10.4103\/0972\u20109062.302030"},{"key":"e_1_2_15_26_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid1511.090886"},{"key":"e_1_2_15_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(95)92620\u20108"},{"key":"e_1_2_15_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/ctm2.1482"},{"key":"e_1_2_15_29_1","doi-asserted-by":"publisher","DOI":"10.59298\/nijbas\/2024\/5.2.24271"},{"key":"e_1_2_15_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473\u20103099(15)00320\u20105"},{"key":"e_1_2_15_31_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40249\u2010017\u20100372\u20105"},{"key":"e_1_2_15_32_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"e_1_2_15_33_1","doi-asserted-by":"crossref","unstructured":"Y. T.Mekasha A. A.Tegegne G.Hasen andS.Belew \u201cArtemisinin\u2010Based Combination Therapies in East Africa: A Systematic Review of Quality Clinical Efficacy and Regulatory Progress Towards Sustainable Malaria Control \u201dPROSPERO 2025 CRD420251135109 https:\/\/www.crd.york.ac.uk\/PROSPERO\/view\/CRD420251135109.","DOI":"10.1111\/tmi.70072"},{"key":"e_1_2_15_34_1","doi-asserted-by":"publisher","DOI":"10.1136\/emermed-2020-209567"},{"key":"e_1_2_15_35_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000052"},{"key":"e_1_2_15_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijsu.2014.07.013"},{"key":"e_1_2_15_37_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.14\u20100725"},{"key":"e_1_2_15_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mib.2022.102193"},{"key":"e_1_2_15_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473\u20103099(24)00427\u20104"},{"key":"e_1_2_15_40_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010024\u201005091\u2010x"},{"key":"e_1_2_15_41_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-019-2872-1"},{"key":"e_1_2_15_42_1","unstructured":"B.Hussein \u201cPost\u2010Market In\u00a0Vitro Quality Evaluation of Artemether\u2010Lumefantrine Tablets Marketed in Addis Ababa and Selected Areas of Oromia Region in Ethiopia \u201d2015Addis Ababa University."},{"key":"e_1_2_15_43_1","unstructured":"WHO \u201cWorld Health Organization (WHO): Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub\u2010Saharan Africa \u201d2011118."},{"key":"e_1_2_15_44_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010018\u20102482\u20103"},{"key":"e_1_2_15_45_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20103156.2006.01769.x"},{"key":"e_1_2_15_46_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.24\u20100145"},{"key":"e_1_2_15_47_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.14\u20100544"},{"key":"e_1_2_15_48_1","volume-title":"United States Pharmacopeia Drug Quality and Information Program. Survey of the Quality of Selected Antimalarial Medicines Circulating in Madagascar, Senegal, and Uganda: November 2009","author":"USP","year":"2010"},{"key":"e_1_2_15_49_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0002132"},{"key":"e_1_2_15_50_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0295956"},{"key":"e_1_2_15_51_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.21\u20101123"},{"key":"e_1_2_15_52_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2024.1472495"},{"key":"e_1_2_15_53_1","first-page":"288","article-title":"The Requirements for Manufacturing Highly Active or Sensitising Drugs Comparing Good Manufacturing Practices","volume":"90","author":"Fabio P.","year":"2019","journal-title":"Acta Bio Medica: Atenei Parmensis"},{"key":"e_1_2_15_54_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.22-0525"},{"key":"e_1_2_15_55_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475\u20102875\u20108\u2010253"},{"key":"e_1_2_15_56_1","volume-title":"Countering the Problem of Falsified and Substandard Drugs","author":"Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health, Institute of Medicine","year":"2013"},{"key":"e_1_2_15_57_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0217910"},{"key":"e_1_2_15_58_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-018-2628-3"},{"key":"e_1_2_15_59_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010024\u201004848\u20108"},{"key":"e_1_2_15_60_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.15-0477"},{"key":"e_1_2_15_61_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2025-020884"},{"key":"e_1_2_15_62_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010018\u20100659\u2010x"},{"key":"e_1_2_15_63_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13031-022-00467-9"},{"key":"e_1_2_15_64_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475-2875-4-14"},{"key":"e_1_2_15_65_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-018-2265-x"},{"key":"e_1_2_15_66_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-015-0826-9"},{"key":"e_1_2_15_67_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0176004"},{"key":"e_1_2_15_68_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-024-05087-7"},{"key":"e_1_2_15_69_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S113603"},{"key":"e_1_2_15_70_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S127571"},{"key":"e_1_2_15_71_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-022-04350-z"},{"key":"e_1_2_15_72_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010020\u201003307\u20104"},{"key":"e_1_2_15_73_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-024-04991-2"},{"key":"e_1_2_15_74_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-022-04436-8"},{"key":"e_1_2_15_75_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-024-05082-y"},{"key":"e_1_2_15_76_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268820003167"},{"key":"e_1_2_15_77_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2023.04.008"},{"key":"e_1_2_15_78_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-018-2524-x"},{"key":"e_1_2_15_79_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475-2875-11-140"},{"key":"e_1_2_15_80_1","unstructured":"J.Andersson \u201cMonitoring of Artemisinin Combination Therapy in Igombe Tanzania \u201d2014."},{"key":"e_1_2_15_81_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010021\u201004021\u20105"},{"key":"e_1_2_15_82_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.21\u20101285"},{"key":"e_1_2_15_83_1","unstructured":"WHO \u201cGlobal Database on Antimalarial Drug Efficacy and Resistance \u201d\u201cGlobal Technical Strategy for Malaria 2016\u20132030\u201d Adopted by the World Health Assembly in May 2015 and Updated in 2021."},{"key":"e_1_2_15_84_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-024-04956-5"},{"key":"e_1_2_15_85_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12889\u2010024\u201019619\u2010y"},{"key":"e_1_2_15_86_1","doi-asserted-by":"publisher","DOI":"10.1093\/heapol\/czz012"},{"key":"e_1_2_15_87_1","doi-asserted-by":"publisher","DOI":"10.1186\/1478\u20104505\u20109\u201022"},{"key":"e_1_2_15_88_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010017\u20101818\u20108"},{"key":"e_1_2_15_89_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0154618"},{"key":"e_1_2_15_90_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0094074"},{"key":"e_1_2_15_91_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010023\u201004692\u20102"},{"key":"e_1_2_15_92_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010023\u201004800\u20102"},{"key":"e_1_2_15_93_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010025\u201005303\u2010y"},{"key":"e_1_2_15_94_1","doi-asserted-by":"publisher","DOI":"10.2147\/IDR.S373059"},{"key":"e_1_2_15_95_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0164332"},{"key":"e_1_2_15_96_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12889\u2010024\u201020036\u20104"},{"key":"e_1_2_15_97_1","volume-title":"Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine","author":"National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Long\u2010Term Health and Economic Effects of Antimicrobial Resistance in the United States","year":"2021"},{"key":"e_1_2_15_98_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010016\u20101292\u20108"},{"key":"e_1_2_15_99_1","unstructured":"Ministry of Health Ethiopia \u201cNational Malaria Elimination Program (NMEP) \u201daccesssed August 11 2025."},{"key":"e_1_2_15_100_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936\u2010023\u201004744\u20107"},{"key":"e_1_2_15_101_1","doi-asserted-by":"publisher","DOI":"10.1093\/heapol\/czl038"},{"key":"e_1_2_15_102_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475\u20102875\u20106\u201072"},{"key":"e_1_2_15_103_1","unstructured":"WHO \u201cTanzania is First African Country to Reach an Important Milestone in the Regulation of Medicines \u201dBrazzaville\/10 December 2018."},{"key":"e_1_2_15_104_1","unstructured":"\u201cNational Malaria Control Program \u201dMinistry of Health Kampala Uganda June 2011."}],"container-title":["Tropical Medicine &amp; International Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/tmi.70072","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/tmi.70072","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/tmi.70072","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T19:09:05Z","timestamp":1772996945000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/tmi.70072"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,23]]},"references-count":103,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1111\/tmi.70072"],"URL":"https:\/\/doi.org\/10.1111\/tmi.70072","archive":["Portico"],"relation":{},"ISSN":["1360-2276","1365-3156"],"issn-type":[{"value":"1360-2276","type":"print"},{"value":"1365-3156","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,23]]},"assertion":[{"value":"2025-08-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}