References
1. Sheffield JS, Siegel D, Mirochnick M, et al. Designing drug trials: considerations for pregnant women. Clin Infect Dis 2014; 59 Suppl 7: S437–44.
2. Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Herna ´ndez-Dı ´az S. Medication use during pregnancy, with particular focus on prescription drugs: 1976–2008. Am J Obstet Gynecol2011;205(1):51.e1–8.
3. Haas DM, Gallauresi B, Shields K, et al. Pharmacotherapy and pregnancy: highlights from the third international conference for individualized pharmacotherapy in pregnancy. Clin Transl Sci2011;4(3):204–9.
4. Lupattelli A, Spigset O, Twigg MJ, et al. Medication use in pregnancy: a cross-sectional, multinational webbased study. BMJ Open 2014;4(2):e004365.
5. LI Guihua, HU Shuyi, SHEN Xinhe, ZHU Liping. Analysis on the characteristics of critical pregnant women in monitoring hospitals.Chinese Journal of Woman and Child Health Research2020;31(6):738-42.
6. Doering PL, Boothby LA, Cheok M. Review of pregnancy labeling of prescription drugs: is the current system adequate to inform of risks?Am J Obstet Gynecol 2002;187(2):333-9.
7. Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth 2008;1(2):5–22.
8. Baylis F. Pregnant women deserve better. Nature2010;465(7299):689–90.
9. Johannes JM, Rieke G. Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans. JAMA2017;317(2):135-136.
10. Shields KE, Lyerly AD. Exclusion of pregnant women from industrysponsored clinical trials. Obstet Gynecol2013;122(5):1077–81.
11. U.S. Department of Health & Human Services. National Institutes of Health Revitalization Act of 1993. Science and Technology. Public Law. June 10, 1993; 103–43.
12. FDA. Pregnancy and lactation labeling final rule. December 3, 2014. Available from: https://www.fda.gov/vaccines-blood-biologics/biologics-rules/pregnancy-and-lactation-labeling-final-rule.
13. Cain J, Lowell J, Thorndyke L, Localio AR. Contraceptive requirements for clinical research. Obstet Gynecol 2000;95(6 Pt 1):861–6.
14. Stockmann C, Sherwin CMT, Koren G, et al. Characteristics and publication patterns of obstetric studies registered in ClinicalTrials. gov. J Clin Pharmacol 2014;54(4): 432-7.
15. Scaffidi J, Mol BW, Keelan JA. The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy. BJOG 2017;124(1):132-40.
16. Zhao S, Lv C, Gong J, et al. Challenges in anticancer drug R&D in China. Lancet Oncol 2019;20(1):183-86.
17. Zhou Q, Chen XY, Yang ZM, Wu YL. The changing landscape of clinical trial and approval processes in China. Nat Rev Clin Oncol2017;14(9):577-83.
18. National Medical Products Administration& National Heath Committee. Announcement on the issuance of quality management practices for drug clinical trials (no. 57 of 2020). April 26, 2020 (in Chinese). Available at: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200426162401243.html.
19. The State Council. Order of the National Health and Family Planning Commission of the People’s Republic of China on Measures for Ethical Review of National Biomedicine Research. October 12, 2016 (in Chinese). Available at:http://www.gov.cn/gongbao/content/2017/content_5227817.htm.
20. Jiang YF, Gen WQ, Zhu YH, Feng Y. The ethical protection for participants of vulnerable groups in clinical trials.Medicine&Philosophy 2017;38(6):25-7.
21. National Medical Products Administration. Announcement on the drug clinical trial information platform. September 6, 2013 (in Chinese). Available at: https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20130906120001263.html.
22. World Health Organization. Primary registries, international clinical trials registry platform. July 25, 2007 (in Chinese). Available at: http://www.gov.cn/jrzg/2007-07/25/content_697236.htm.
23. Ayad M, Costantine MM. Epidemiology of medications use in pregnancy.Semin Perinatol 2015;39(7):508-11.
24. McCormack SA, Best BM. Obstetric pharmacokinetic dosing studies are urgently needed. Front Pediatr 2014;2:9.
25. Shields KE, Lyerly AD. Exclusion of pregnant women from industrysponsored clinical trials. Obstet Gynecol2013;122(5):1077-81.
26. Kass NE, Taylor HA, Anderson J. Treatment of human immunodeficiency virus during pregnancy: The shift from an exclusive focus on fetal protection to a more balanced approach. Am J Obstet Gynecol2000;182(4):856-9.
27. Mastroianni A, Kahn J. Swinging on the pendulum: Shifting views of justice in human subjects research. Hastings Cent Rep2001;31(3):21-8.
28. General Office of the State Council. State Council General Office’s opinion on the evaluation of the consistency of quality and efficacy of generic drugs. March 5, 2016 (in Chinese). Available at: http://www.gov.cn/zhengce/content/2016-03/05/content_5049364.htm.
29. The State Council. State Council’s opinions on reforming the examination and approval system for drug and medical devices. Aug 18, 2015 (in Chinese). Available at: http://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm.
30. China Food and Drug Administration. Announcement of the General Administration on the work plan for the reform of the registration of chemical drugs (no. 51 of 2016). March 9, 2016 (in Chinese). Available at: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20160309151801706.html.
31. The General Office of the Central Committee of the Communist Party of China, the General Office of the State Council. The General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the “Opinions on deepening the reform of the examination and approval system and encouraging the innovation of pharmaceutical medical devices”. October 8, 2017 (in Chinese). Available at: http://www.gov.cn/zhengce/2017-10/08/ content_5230105.htm.
32. National Medical Products Administration, National Health Commission. Announcement of the State Drug Administration and the State Health Commission on optimizing the examination and approval of drug registration and examination (no. 23 of 2018). May 23, 2018 (in Chinese). Available at: https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20180523110601517.html.
33. National Medical Products Administration. Announcement of the State Drug Administration on adjusting the approval process for drug clinical trial evaluation (no. 50 of 2018). July 27, 2018 (in Chinese). Available at: https://www.nmpa.gov.cn/xxgk/ggtg/ywlchshyjgrdgg/20180727172901286.html.
34. National Medical Products Administration. Announcement on the issuance of three documents including the “Working Procedures for Evaluation of Breakthrough Therapeutics (Trial)” (no. 82 of 2020). July 7, 2020 (in Chinese). Available at: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200708151701834.html.
35. Ning Li, Hui-Yao Huang, Da-Wei Wu, et al. Changes in clinical trials of cancer drugs in mainland China over the decade 2009–18: a systematic review. Lancet Oncol 2019;20(11):e619–26.
36. National Heath Committee. Notice on printing and distributing the requirements for the work of the construction of the major clinical drug evaluation technology platform for major new drugs. Jan 21, 2019 (in Chinese). Available at: http://www.nhc.gov.cn/qjjys/s3593k/201901/f4b2ff724a564b35964b296b427b9002.shtml.