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.	國家食品藥品監督管理總局南方醫藥經濟研究所. 2016年兒童用藥安全調查報告白皮書. Available at: http://www.zyzhan.com/ news/Detail/57675.html.
10.	聯合國開發計劃署. 2015年《千年發展目標報告》. Available at: http://www.cn.undp.org/content/china/zh/home/library/mdg/ mdg-report-2015/.
11.	國家衛生計生委等六部委. 關于保障兒童用藥的若干意見. Available at: http://www.nhfpc.gov.cn/yaozs/s3581/201405/ e51354d631944fa68aac0c4d9585f291.shtml.
12.	國家衛生計生委辦公廳. 關于進一步加強醫療機構兒童用藥配備使用工作的通知. Available at: http://www.moh.gov.cn/yaozs/ s3581/201509/9b2616ea65014257b2970df81ce46a8c.shtml.
13.	國家食品藥品監督管理總局藥品審評中心. 關于臨床急需兒童用藥申請優先審評審批品種評定基本原則及首批優先審評品種的公告. Available at: http://www.cde.org.cn/news.do? method=viewInfoCommon&id=313519.
14.	國家衛生計生委等六部委. 關于印發加強兒童醫療衛生服務改革與發展意見的通知. Available at: http://www.mohrss.gov.cn/ SYrlzyhshbzb/shehuibaozhang/zcwj/yiliao/201606/t20160601_241098.html.
15.	胡錦濤. 中國共產黨第十七次全國代表大會報告. 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.	劉怡, 程靜, 張伶俐, 等. 全球兒童基本藥物目錄構建方法的比較研究. 中國循證醫學雜志, 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.	劉丹, 程靜, 張伶俐, 等. WHO、印度、南非兒童基本藥物目錄與中國 2012 版基本藥物目錄的比較研究. 中國循證醫學雜志, 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.	王曉玲. 兒童藥物臨床試驗的國內外現狀研究. 中國藥物評價, 2013, 30(3): 167-170.
28.	國家食品藥品監督管理總局. 藥物臨床試驗機構認定公告. Available at: http://www.sda.gov.cn/WS01/CL0069/index.html.
29.	生物探索. 兒童藥, 真的難成氣候嗎. 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. 藥物警戒概述. 中國藥物警戒, 2009, 6(1): 60-62.
35.	李青. 我國藥品上市后監測工作及國家藥物政策的基礎研究. 武漢: 華中科技大學, 2004.
36.	黃芳華, 王慶利, Ridings J, 等. 國外兒科藥物研發的監管要求和研發策略. 中國新藥雜志, 2016, 25(19): 2174-2182.
37.	江寒冰. 兒童不合理用藥因素分析. 中國保健營養: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. 國家食品藥品監督管理總局南方醫藥經濟研究所. 2016年兒童用藥安全調查報告白皮書. Available at: http://www.zyzhan.com/ news/Detail/57675.html.
10. 聯合國開發計劃署. 2015年《千年發展目標報告》. Available at: http://www.cn.undp.org/content/china/zh/home/library/mdg/ mdg-report-2015/.
11. 國家衛生計生委等六部委. 關于保障兒童用藥的若干意見. Available at: http://www.nhfpc.gov.cn/yaozs/s3581/201405/ e51354d631944fa68aac0c4d9585f291.shtml.
12. 國家衛生計生委辦公廳. 關于進一步加強醫療機構兒童用藥配備使用工作的通知. Available at: http://www.moh.gov.cn/yaozs/ s3581/201509/9b2616ea65014257b2970df81ce46a8c.shtml.
13. 國家食品藥品監督管理總局藥品審評中心. 關于臨床急需兒童用藥申請優先審評審批品種評定基本原則及首批優先審評品種的公告. Available at: http://www.cde.org.cn/news.do? method=viewInfoCommon&id=313519.
14. 國家衛生計生委等六部委. 關于印發加強兒童醫療衛生服務改革與發展意見的通知. Available at: http://www.mohrss.gov.cn/ SYrlzyhshbzb/shehuibaozhang/zcwj/yiliao/201606/t20160601_241098.html.
15. 胡錦濤. 中國共產黨第十七次全國代表大會報告. 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. 劉怡, 程靜, 張伶俐, 等. 全球兒童基本藥物目錄構建方法的比較研究. 中國循證醫學雜志, 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. 劉丹, 程靜, 張伶俐, 等. WHO、印度、南非兒童基本藥物目錄與中國 2012 版基本藥物目錄的比較研究. 中國循證醫學雜志, 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. 王曉玲. 兒童藥物臨床試驗的國內外現狀研究. 中國藥物評價, 2013, 30(3): 167-170.
28. 國家食品藥品監督管理總局. 藥物臨床試驗機構認定公告. Available at: http://www.sda.gov.cn/WS01/CL0069/index.html.
29. 生物探索. 兒童藥, 真的難成氣候嗎. 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. 藥物警戒概述. 中國藥物警戒, 2009, 6(1): 60-62.
35. 李青. 我國藥品上市后監測工作及國家藥物政策的基礎研究. 武漢: 華中科技大學, 2004.
36. 黃芳華, 王慶利, Ridings J, 等. 國外兒科藥物研發的監管要求和研發策略. 中國新藥雜志, 2016, 25(19): 2174-2182.
37. 江寒冰. 兒童不合理用藥因素分析. 中國保健營養: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