Development and clinical safety of paediatric medicines in China

doi:10.19803/j.1672-8629.20220720

Abstract

Abstract: Objective To explore the priorities of development of paediatric medicines in China and give advice on the safety of paediatric drugs in clinical use. Methods By analyzing the guidelines, regulations and related literature on development of paediatric medicines and clinical use at home and abroad in recent years, the status quo of and problems with development of paediatric medicines in China were presented, and the factors influencing the safety of clinical use of paediatric medicines were clarified. Results and Conclusion In view of the challenges to paediatric medicines and with reference to related experience, this paper outlines the prospect of the research and development of paediatric medicines and clinical drug safety in China, and puts forward corresponding countermeasures and suggestions.

Key words: paediatric medicines, drug development, clinical drug safety, current situation, outlook

CLC Number:

R951

JIANG Jiandong. Development and clinical safety of paediatric medicines in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 1-6.

References

[1] WANG ZF, LI J.Current situation, problems and policy suggestions of children's medical security in China[J]. Lanzhou Academic Journal(兰州学刊), 2022(9): 113-123.
[2] KUANG JL, TAO MY, ZHANG T, et al.Analysis of current situation of pediatric drugs at home and abroad[J]. Pharmacy and Clinics of Chinese Materia Medica(中药与临床), 2022, 13(5): 97-99.
[3] YUAN J.A few thoughts on the issue of medication use in children[C]. Proceedings of the Sixth Annual National Academic Conference on Therapeutic Drug Monitoring(第六届全国治疗药物监测学术年会论文摘要集), 2016: 26.
[4] WANG SY, LUO DM, HUANG Y, et al.Body composition longitudinal development characteristics of preschoolers[J]. China Sport Science and Technology(中国体育科技), 2021, 57(12): 101-108.
[5] ZHANG Q, YANG ZY, LI RL, et al.National Nutrition and Health Systematic Survey for 0-18 years old children in China:study protocol for 6-18 years old children[J]. Journal of Hygiene Research(卫生研究), 2022, 51(5): 703-706.
[6] WANG L, HUANG Z.Real world evidence ameliorates barriers to drug clinical trials in children[J]. Chinese Journal of New Drugs(中国新药杂志), 2022, 31(19): 1872-1875.
[7] CHEN K, XU WW, GE YN.The age structure of China's population and its impact on economic development[J]. Trade Fair Economy(商展经济), 2022(13): 110-112.
[8] WANG XL, CAO LJ, LIANG YG, et al.Establishing risk management system and insurance system for pediatric drugs in China[J].China Food & Drug Administration Magazine(中国食品药品监管), 2021(1): 28-35.
[9] ZHANG JF, TONG RF, HUANG T, et al.Comparative analysis of the dosage forms and specifications of OTC(chemical drugs) for children at home and abroad[J].China Pharmacy(中国药房), 2022, 33(21): 2561-2565.
[10] LIU Y, ZOU AY, SHANG HC.Analysis of medicine utilizaitons for children in China with information from package inserts of commonly used medicines in our hospital[J]. Tianjin Pharmacy(天津药学), 2016, 28(6): 32-35.
[11] LU GP.How to regulate the use of over-specified drugs in children[J]. Chinese Pediatric Emergency Medicine(中国小儿急救医学), 2018, 25(1): 18-21.
[12] WANG ZY, HAN TS, HE YG, et al.Study on the availability of essential medicines for children at 18 tertiary children's hospitals[J].China Pharmacy(中国药房), 2022, 33(18): 2177-2181.
[13] WANG YT.Current situation, problems and countermeasures of children's medication in China[D]. Beijing: Beijing University of Chinese Medicine, 2018.
[14] WANG XY, SU WW, DING H, et al.Problems of clinical use in pediatric drug and countermeasures analysis in China[J].China Pharmacy(中国药房), 2019, 30(2): 149-153.
[15] LI FS, YU Qin.International development and domestic situation of pediatric medication development and clinical trials[J]. Chinese Journal of New Drugs(中国新药杂志), 2020, 29(17): 1933-1938.
[16] GENG Y, ZHAO DH, YANG ZM.Considerations on post marketing real world data collection for pediatric drugs in China[J]. Chinese Journal of New Drugs(中国新药杂志), 2018, 27(18): 2107-2110.
[17] The State Council of the People's Republic of China. Law of the People's Republic of China on Medical Practitioners(中华人民共和国医师法)[EB/OL].(2021-08-20)[2022-12-14]. http://www.gov.cn/xinwen/2021-08/20/content_5632496.htm.
[18] The State Council of the People's Republic of China. Programme for the Development of Chinese Children (2011-2020)[中国儿童发展纲要(2011—2020年)][EB/OL]. (2011-08-09)[2022-12-14]. http://www.gov.cn/jrzg/2011-08/09/content_1921982.htm.
[19] The State Council of the People's Republic of China. Several opinions on safeguarding children's medication(关于保障儿童用药的若干意见)[EB/OL].(2014-05-30)[2022-12-14]. http://www.nhc.gov.cn/yaozs/s3581/201405/e51354d631944fa68aac0c4d9585f291.shtml.
[20] The State Council of the People's Republic of China. Drug Administration Law of the People's Republic of China(中华人民共和国药品管理法)[EB/OL].(2019-08-26)[2022-12-14]. http://www.gov.cn/xinwen/2019-08/26/content_5424780.htm.
[21] The State Council of the People's Republic of China.Opinions of the State Council on reforming the review and approval system for pharmaceuticals and medical devices(国务院关于改革药品医疗器械审评审批制度的意见)[EB/OL].(2015-08-18)[2022-12-14]. http://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm.
[22] Center For Drug Evaluation, NMPA. News[EB/OL].[2022-12-14]. https://www.cde.org.cn.
[23] Center For Drug Evaluation, NMPA. Guideline Column[EB/OL].[2022-12-14]. https://www.cde.org.cn/zdyz/fullsearchpage.
[24] LI WJ, LU MQ, LI Y, et al.Development and thinking of individualized formulation for children at home and abroad[J] Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2020, 40(12): 1396-1399.
[25] NIH. Best Pharmaceuticals for Children Act( BPCA) History[EB/OL].[2022-12-15].https://www.nichd.nih.gov/research/supported/bpca/history.
[26] FDA. Food and Drug Administration Modernization Act[EB/OL]. [2022-12-15]. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-modernization-act-fdama-1997.
[27] Food and Drug Administration. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients: final rule[J]. Federal Register, 1998, 63: 66632-66672.
[28] FDA. Best Pharmaceuticals for Children Act[EB/OL].[2022-12-15]. https://www.fda.gov/drugs/development-resources/best-pharmaceuticals-children-act-bpca.
[29] FDA. Pediatric Research Equity Act[EB/OL].[2022-12-15]. https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea.
[30] European Commission.Medicines For Children[EB/OL]. [2022-12-15].https://health.ec.europa.eu/medicinal-products/medicines-children_en.
[31] The State Council of the People's Republic of China. Programme for the Development of Chinese Children (2021-2030)[中国儿童发展纲要(2021—2030年)][EB/OL]. (2021-09-27)[2022-12-14]. http://www.gov.cn/xinwen/2021-09/27/content_5639545.htm.
[32] WANG YR.XU BP: Advocating for specialised medicines suitable for children[J]. China Health(中国卫生), 2021(12): 76-77.