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Objective: This work compares the marketing authorization, labels and dosage forms of medicines in the WHO Model List of Essential Medicines for Children (EMLc) in China, the Russian Federation and Brazil to urge policymakers to pay more attention to paediatric medication.

Methods: Medicines were selected from the 8th EMLc. By searching relevant databases, which include different types of medical information in China, the Russian Federation and Brazil, the marketing authorization, labels and dosage forms of paediatric medicines in the three countries were evaluated.

Results: A total of 485 drug products containing 312 active pharmaceutical ingredients listed in the WHO EMLc were evaluated. Among them, 344 products were approved for use in China, 286 in the Russian Federation and 264 in Brazil. Out of the 344 approved medicines, 317 (92.15%) were authorized for paediatric use in China, 224 (78.32%) in the Russian Federation and 218 (82.58%) in Brazil. In terms of guidance information labelling on drug labels, 75.08%, 83.04% and 88.07% of paediatric drugs approved in China, the Russian Federation and Brazil, respectively, clearly indicated the usage and dosage for paediatric use. Additionally, injections and tablets were the most prevalent dosage forms in these three countries.

Conclusion: There is still scope for enhancing the marketing authorization and development of dosage forms for paediatric medicines in the three countries. Furthermore, additional measures are being implemented to enhance the information provided on drug labels for children, particularly in China.

Titel:	Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil.
Autor/in / Beteiligte Person:	Li, C ; Cheng, L ; Zhang, X ; Zhang, L ; Yan, J
Zeitschrift:	Health research policy and systems, Jg. 22 (2024-03-05), Heft 1, S. 33
Veröffentlichung:	[London] : BioMed Central, 2003-, 2024
Medientyp:	academicJournal
ISSN:	1478-4505 (electronic)
DOI:	10.1186/s12961-024-01117-7
Schlagwort:	Humans Child Brazil China Russia World Health Organization Marketing
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article Language: English [Health Res Policy Syst] 2024 Mar 05; Vol. 22 (1), pp. 33. <i>Date of Electronic Publication: </i>2024 Mar 05. MeSH Terms: Marketing* ; Humans ; Child ; Brazil ; China ; Russia ; World Health Organization References: BMC Public Health. 2021 Apr 13;21(1):714. (PMID: 33849513) ; Ital J Pediatr. 2010 Aug 17;36:56. (PMID: 20716337) ; Eur J Clin Pharmacol. 2006 Dec;62(12):1065-73. (PMID: 17024485) ; Rev Bras Ter Intensiva. 2021 Apr-Jun;33(2):266-275. (PMID: 34231807) ; Drug Discov Today. 2016 Oct;21(10):1566-1570. (PMID: 27319291) ; JAMA Pediatr. 2014 Feb;168(2):130-6. (PMID: 24322269) ; BMC Pediatr. 2016 Mar 15;16:40. (PMID: 26979737) ; BMJ Open. 2021 Aug 3;11(8):e051465. (PMID: 34344685) ; PLoS One. 2022 Nov 9;17(11):e0276785. (PMID: 36350812) ; J Pharm Policy Pract. 2015 Jul 15;8(1):19. (PMID: 26203358) ; Int J Mol Sci. 2019 Jun 29;20(13):. (PMID: 31261877) ; Front Pharmacol. 2021 Aug 05;12:691606. (PMID: 34421594) ; Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):329-33. (PMID: 23280570) ; Bull World Health Organ. 2017 Mar 1;95(3):238-240. (PMID: 28250539) ; J Clin Pharmacol. 2021 Jun;61 Suppl 1:S133-S140. (PMID: 34185899) ; BMC Health Serv Res. 2020 May 6;20(1):377. (PMID: 32375749) ; Br J Clin Pharmacol. 2023 Mar;89(3):1056-1066. (PMID: 36189466) ; J Pharm Policy Pract. 2017 Jan 6;10:4. (PMID: 28070339) ; Expert Rev Clin Pharmacol. 2011 Sep;4(5):643-52. (PMID: 21980319) ; Adv Drug Deliv Rev. 2014 Jun;73:2-13. (PMID: 24556465) ; J Gen Intern Med. 2016 Dec;31(12):1482-1489. (PMID: 27542666) ; Pharmaceutics. 2020 Apr 01;12(4):. (PMID: 32244848) ; Cad Saude Publica. 2017 Jun 12;33(5):e00169515. (PMID: 28614452) ; Ther Innov Regul Sci. 2017 May 1;51(3):360-371. (PMID: 28674673) ; Bull World Health Organ. 2014 Jun 1;92(6):388. (PMID: 24940008) ; J Pharm Policy Pract. 2015 Jan 31;8(1):2. (PMID: 25815197) ; Basic Clin Pharmacol Toxicol. 2018 Apr;122(4):402-412. (PMID: 29117642) ; BMC Pediatr. 2022 Mar 18;22(1):144. (PMID: 35303815) ; Curr Ther Res Clin Exp. 2019 Jan 26;90:128-134. (PMID: 31388368) ; Value Health Reg Issues. 2018 Sep;16:106-111. (PMID: 30327255) ; J Pediatr. 2016 Oct;177S:S148-S155. (PMID: 27666264) ; Arch Dis Child. 2013 Sep;98(9):725-31. (PMID: 23853004) Grant Information: 72274217 National Natural Science Foundation of China; 22YJAZH126 General Project of Humanities and Social Sciences Research of the Ministry of Education of China Contributed Indexing: Keywords: Brazil; China; Drug labels; Essential medicines for children; The Russian Federation Entry Date(s): Date Created: 20240305 Date Completed: 20240307 Latest Revision: 20240308 Update Code: 20240308 PubMed Central ID: PMC10913573

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Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil.