Promoting innovation and access to quality, safe, efficacious and affordable medicines for children: a China approach on the 69<sup>th</sup> World Health Assembly _Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Lingli ^1,2,3 , LI Bo ⁴ , LIU Zhanqiang ⁴ , LI Mengtao ⁴ , ZHENG Hong ⁴ ,  SUN Yang ^4,5

1. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, 610041, P.R.China;
3. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, 610041, P.R.China;
4. Department of Drug Policy and Essential Medicine, National Health and Family Planning Commission, Beijing, 100044, P.R.China;
5. National Center for Medical Service Administration, National Health and Family Planning Commission, Beijing, 100044, P.R.China;

Corresponding author：

SUN Yang, Email: sunnypumch@163.com

Keywords：

Medicines for children; Quality; Safe; Efficacious; Affordable; Accessibility; World Health Assembly; China's Resolution

DOI：

10.7507/1672-2531.201703101

Video：

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This study is to provide reference for the proper understanding of the content of " Promoting innovation and access to quality, safe, efficacious, and affordable medicines for children” resolution of 69^th World Health Assembly (WHA), and facilitate the policy making and implication of the Resolution. Through descriptive analysis, the author introduce the proposal background and approving process of the resolution, and interpret the resolution content. The approval of " Promoting innovation and access to quality, safe, efficacious, and affordable medicines for children” at WHA represents China's international discourse right on improving the basic medical service among children, the most vulnerable population; highlights China's responsibility and magnitude of a great nation. It is an effective promotion for China's new medical reform and the implication of the Millennium Development Goals (MDGs), as well as a great contribution to the global health of children from China.

Citation： ZHANG Lingli, LI Bo, LIU Zhanqiang, LI Mengtao, ZHENG Hong, SUN Yang. Promoting innovation and access to quality, safe, efficacious and affordable medicines for children: a China approach on the 69^th World Health Assembly . Chinese Journal of Evidence-Based Medicine, 2017, 17(6): 621-626. doi: 10.7507/1672-2531.201703101 Copy

1.	The United Nations. Millennium goals. Available at: http://www.un.org/millenniumgoals/childhealth.shtml.
2.	The United Nations. Sustainable development goals. Available at: http://www.un.org/sustainabledevelopment/health/.
3.	World Health Organization. World health statistics 2012. Available at: http://apps.who.int/iris/bitstream/10665/44844/1/ 9789241564441_eng.pdf?ua=1.
4.	World Health Organization. The global burden of disease: 2004 update. Available at: http://www.who.int/healthinfo/global_ burden_disease/GBD_report_2004update_full.pdf?ua=1.
5.	Bryce J, Boschi-Pinto C, Shibuya K, et al. WHO estimates of the causes of death in children. Lancet, 2005, 365(9465): 1147-1152.
6.	World Health Organization. Children’s medicines: A situational analysis 2011. Available at: http://www.who.int/ childmedicines/en/.
7.	Menson EN, Walker AS, Gibb DM. Clinical trials in children. Lancet, 2004, 364(9452): 2176-2177.
8.	FDA. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients-FDA. Final rule. Fed Regist, 1998, 63(231): 66631-66672.
9.	国家食品药品监督管理总局南方医药经济研究所. 2016年儿童用药安全调查报告白皮书. Available at: http://www.zyzhan.com/ news/Detail/57675.html.
10.	联合国开发计划署. 2015年《千年发展目标报告》. Available at: http://www.cn.undp.org/content/china/zh/home/library/mdg/ mdg-report-2015/.
11.	国家卫生计生委等六部委. 关于保障儿童用药的若干意见. Available at: http://www.nhfpc.gov.cn/yaozs/s3581/201405/ e51354d631944fa68aac0c4d9585f291.shtml.
12.	国家卫生计生委办公厅. 关于进一步加强医疗机构儿童用药配备使用工作的通知. Available at: http://www.moh.gov.cn/yaozs/ s3581/201509/9b2616ea65014257b2970df81ce46a8c.shtml.
13.	国家食品药品监督管理总局药品审评中心. 关于临床急需儿童用药申请优先审评审批品种评定基本原则及首批优先审评品种的公告. Available at: http://www.cde.org.cn/news.do? method=viewInfoCommon&id=313519.
14.	国家卫生计生委等六部委. 关于印发加强儿童医疗卫生服务改革与发展意见的通知. Available at: http://www.mohrss.gov.cn/ SYrlzyhshbzb/shehuibaozhang/zcwj/yiliao/201606/t20160601_241098.html.
15.	胡锦涛. 中国共产党第十七次全国代表大会报告. Available at: http://news.sina.com.cn/c/2007-10-24/205814157282.shtml.
16.	World Health Assembly. Better medicines for children (WHA 60.20). Available at: http://apps.who.int/gb/ebwha/ pdf_files/WHASSA_WHA60-Rec1/C/reso-60-ch.pdf.
17.	World Health Organization. How to develop and implement a national drug policy. 2nd edition. WHO, 2001: 1-96.
18.	刘怡, 程静, 张伶俐, 等. 全球儿童基本药物目录构建方法的比较研究. 中国循证医学杂志, 2015, 15(5): 514-523.
19.	World Health Assembly. Workers’ health: draft global plan of action (WHA 60.20). Available at: http://apps.who.int/gb/ebwha/ pdf_files/WHA60/A60_20-en.pdf.
20.	World Health Assembly. Regulatory system strengthening for medical products (WHA 67.20). Available at: http://apps. who.int/gb/ebwha/pdf_files/WHA67-REC1/A67_2014_REC1-ch.pdfpage=25.
21.	World Health Organization. The right to health. Available at: http://www.refworld.org/docid/48625a742.html.
22.	World Health Organization. Health Topics: Essential Medicines. Available at: http://www.who.int/topics/essential_medicines/en/.
23.	刘丹, 程静, 张伶俐, 等. WHO、印度、南非儿童基本药物目录与中国 2012 版基本药物目录的比较研究. 中国循证医学杂志, 2015, 15(4): 393-402.
24.	World Health Assembly. Progress in the rational use of medicines (WHA 60.24). Available at: http://apps.who.int/gb/ebwha/ pdf_files/WHA60/A60_24-en.pdf.
25.	World Health Assembly. Progress reports (WHA 66.27). Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA66/A66_27-ch.pdf.
26.	World Health Organization. Measuring medicine prices, availability, affordability and price components (2nd edition). Available at: http://apps.who.int/medicinedocs/documents/ s14868e/s14868e.pdf?ua=1.
27.	王晓玲. 儿童药物临床试验的国内外现状研究. 中国药物评价, 2013, 30(3): 167-170.
28.	国家食品药品监督管理总局. 药物临床试验机构认定公告. Available at: http://www.sda.gov.cn/WS01/CL0069/index.html.
29.	生物探索. 儿童药, 真的难成气候吗. Available at: http:// biodiscover.baijia.baidu.com/article/470284.
30.	World Health Assembly. Ministerial summit on health research (WHA 58.34). Available at: http://apps.who.int/gb/archive/ pdf_files/WHA58/WHA58_34-ch.pdf.
31.	World Health Organization. International clinical trials registry platform. Available at: http://www.who.int/ictrp/network/ primary/en/.
32.	Moorthy VS, Karam G, Vannice KS, et al. Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS Med, 2015, 12(4): e1001819.
33.	World Health Organization. All trials, all results. Bull World Health Organ, 2015, 93: 288-289.
34.	Aquino P. 药物警戒概述. 中国药物警戒, 2009, 6(1): 60-62.
35.	李青. 我国药品上市后监测工作及国家药物政策的基础研究. 武汉: 华中科技大学, 2004.
36.	黄芳华, 王庆利, Ridings J, 等. 国外儿科药物研发的监管要求和研发策略. 中国新药杂志, 2016, 25(19): 2174-2182.
37.	江寒冰. 儿童不合理用药因素分析. 中国保健营养:下旬刊, 2013, 23(10): 6013-6014.
38.	Global Research in Pediatrics. Objectives and results. Available at: http://www.grip-network.org/index.php/cms/en/objectives_ and_results.
39.	WHO Expert Committee. The selection and use of essential medicines, 2013. Available at: http://apps.who.int/iris/bitstream/ 10665/112729/1/WHO_TRS_985_eng.pdf.
40.	Sharma A, Jacob A, Tandon M, et al. Orphan drug: development trends and strategies. J Pharm Bioallied Sci, 2010, 2(4): 290-299.
41.	Brewer GJ. Drug development for orphan diseases in the context of personalized medicine. Transl Res, 2009, 154(6): 314-322.

1. The United Nations. Millennium goals. Available at: http://www.un.org/millenniumgoals/childhealth.shtml.
2. The United Nations. Sustainable development goals. Available at: http://www.un.org/sustainabledevelopment/health/.
3. World Health Organization. World health statistics 2012. Available at: http://apps.who.int/iris/bitstream/10665/44844/1/ 9789241564441_eng.pdf?ua=1.
4. World Health Organization. The global burden of disease: 2004 update. Available at: http://www.who.int/healthinfo/global_ burden_disease/GBD_report_2004update_full.pdf?ua=1.
5. Bryce J, Boschi-Pinto C, Shibuya K, et al. WHO estimates of the causes of death in children. Lancet, 2005, 365(9465): 1147-1152.
6. World Health Organization. Children’s medicines: A situational analysis 2011. Available at: http://www.who.int/ childmedicines/en/.
7. Menson EN, Walker AS, Gibb DM. Clinical trials in children. Lancet, 2004, 364(9452): 2176-2177.
8. FDA. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients-FDA. Final rule. Fed Regist, 1998, 63(231): 66631-66672.
9. 国家食品药品监督管理总局南方医药经济研究所. 2016年儿童用药安全调查报告白皮书. Available at: http://www.zyzhan.com/ news/Detail/57675.html.
10. 联合国开发计划署. 2015年《千年发展目标报告》. Available at: http://www.cn.undp.org/content/china/zh/home/library/mdg/ mdg-report-2015/.
11. 国家卫生计生委等六部委. 关于保障儿童用药的若干意见. Available at: http://www.nhfpc.gov.cn/yaozs/s3581/201405/ e51354d631944fa68aac0c4d9585f291.shtml.
12. 国家卫生计生委办公厅. 关于进一步加强医疗机构儿童用药配备使用工作的通知. Available at: http://www.moh.gov.cn/yaozs/ s3581/201509/9b2616ea65014257b2970df81ce46a8c.shtml.
13. 国家食品药品监督管理总局药品审评中心. 关于临床急需儿童用药申请优先审评审批品种评定基本原则及首批优先审评品种的公告. Available at: http://www.cde.org.cn/news.do? method=viewInfoCommon&id=313519.
14. 国家卫生计生委等六部委. 关于印发加强儿童医疗卫生服务改革与发展意见的通知. Available at: http://www.mohrss.gov.cn/ SYrlzyhshbzb/shehuibaozhang/zcwj/yiliao/201606/t20160601_241098.html.
15. 胡锦涛. 中国共产党第十七次全国代表大会报告. Available at: http://news.sina.com.cn/c/2007-10-24/205814157282.shtml.
16. World Health Assembly. Better medicines for children (WHA 60.20). Available at: http://apps.who.int/gb/ebwha/ pdf_files/WHASSA_WHA60-Rec1/C/reso-60-ch.pdf.
17. World Health Organization. How to develop and implement a national drug policy. 2nd edition. WHO, 2001: 1-96.
18. 刘怡, 程静, 张伶俐, 等. 全球儿童基本药物目录构建方法的比较研究. 中国循证医学杂志, 2015, 15(5): 514-523.
19. World Health Assembly. Workers’ health: draft global plan of action (WHA 60.20). Available at: http://apps.who.int/gb/ebwha/ pdf_files/WHA60/A60_20-en.pdf.
20. World Health Assembly. Regulatory system strengthening for medical products (WHA 67.20). Available at: http://apps. who.int/gb/ebwha/pdf_files/WHA67-REC1/A67_2014_REC1-ch.pdfpage=25.
21. World Health Organization. The right to health. Available at: http://www.refworld.org/docid/48625a742.html.
22. World Health Organization. Health Topics: Essential Medicines. Available at: http://www.who.int/topics/essential_medicines/en/.
23. 刘丹, 程静, 张伶俐, 等. WHO、印度、南非儿童基本药物目录与中国 2012 版基本药物目录的比较研究. 中国循证医学杂志, 2015, 15(4): 393-402.
24. World Health Assembly. Progress in the rational use of medicines (WHA 60.24). Available at: http://apps.who.int/gb/ebwha/ pdf_files/WHA60/A60_24-en.pdf.
25. World Health Assembly. Progress reports (WHA 66.27). Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA66/A66_27-ch.pdf.
26. World Health Organization. Measuring medicine prices, availability, affordability and price components (2nd edition). Available at: http://apps.who.int/medicinedocs/documents/ s14868e/s14868e.pdf?ua=1.
27. 王晓玲. 儿童药物临床试验的国内外现状研究. 中国药物评价, 2013, 30(3): 167-170.
28. 国家食品药品监督管理总局. 药物临床试验机构认定公告. Available at: http://www.sda.gov.cn/WS01/CL0069/index.html.
29. 生物探索. 儿童药, 真的难成气候吗. Available at: http:// biodiscover.baijia.baidu.com/article/470284.
30. World Health Assembly. Ministerial summit on health research (WHA 58.34). Available at: http://apps.who.int/gb/archive/ pdf_files/WHA58/WHA58_34-ch.pdf.
31. World Health Organization. International clinical trials registry platform. Available at: http://www.who.int/ictrp/network/ primary/en/.
32. Moorthy VS, Karam G, Vannice KS, et al. Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS Med, 2015, 12(4): e1001819.
33. World Health Organization. All trials, all results. Bull World Health Organ, 2015, 93: 288-289.
34. Aquino P. 药物警戒概述. 中国药物警戒, 2009, 6(1): 60-62.
35. 李青. 我国药品上市后监测工作及国家药物政策的基础研究. 武汉: 华中科技大学, 2004.
36. 黄芳华, 王庆利, Ridings J, 等. 国外儿科药物研发的监管要求和研发策略. 中国新药杂志, 2016, 25(19): 2174-2182.
37. 江寒冰. 儿童不合理用药因素分析. 中国保健营养:下旬刊, 2013, 23(10): 6013-6014.
38. Global Research in Pediatrics. Objectives and results. Available at: http://www.grip-network.org/index.php/cms/en/objectives_ and_results.
39. WHO Expert Committee. The selection and use of essential medicines, 2013. Available at: http://apps.who.int/iris/bitstream/ 10665/112729/1/WHO_TRS_985_eng.pdf.
40. Sharma A, Jacob A, Tandon M, et al. Orphan drug: development trends and strategies. J Pharm Bioallied Sci, 2010, 2(4): 290-299.
41. Brewer GJ. Drug development for orphan diseases in the context of personalized medicine. Transl Res, 2009, 154(6): 314-322.

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Promoting innovation and access to quality, safe, efficacious and affordable medicines for children: a China approach on the 69th World Health Assembly

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Promoting innovation and access to quality, safe, efficacious and affordable medicines for children: a China approach on the 69^th World Health Assembly