Abstract
This chapter reviews the regulatory situation for clinical stem cell research in the People’s Republic of China since the early 2000s. The paper is structured in four parts. Part I examines the regulatory conditions for the donation of human gametes and embryos and their use in basic and preclinical research. This involves an overview of China’s regulatory rules for assisted reproductive technologies (ART) and its approach to the governance of human embryonic stem cell (hESC) research. Part II offers a summary of the regulatory and legal instruments that govern clinical trials and other forms of human subjects research in China. These instruments, most of which have been launched in the 1990s and early 2000s, do not specifically address stem cell research, but they influence clinical stem cell research as horizontal regulatory rules. Part III focuses more specifically to the regulation of clinical stem cell research and applications, including the regulation of experimental (for-profit) interventions with stem cells that do not classify as clinical trials or systematic forms of clinical research. This part documents the formation of a regulatory approach for clinical stem cell applications since the mid-2000s, which was still ongoing at the time of writing. The conclusions discuss open questions and the repercussions of China’s regulatory approach for stem cell research for domestic researchers, clinicians, and corporations in China, as well as for international clinical and corporate collaborations.
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Notes
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This chapter is based on a working paper and two publications that the authors of this chapter have published in 2013 and 2015:
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Rosemann A, Zhang X, Sui S, Su Y, Ely, A (2013) Country report: Stem cell research in China. Working Paper, Centre for Bionetworking, University of Sussex. (This working paper forms the basis for Sects. 13.1, 13.2, and 13.3 of this chapter.)
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Rosemann A (2013) Medical innovation and national experimental pluralism: Insights from clinical stem cell research and applications in China. BioSocieties 8(1):58–74. (This paper forms the basis for Sects. 13.4, 13.4.1, 13.4.2, and 13.4.3 of this chapter.) (Palgrave MacMillan provides the right to the authors to use this information in this chapter.)
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Rosemann A, Sleeboom-Faulkner M (2015) New regulation for clinical stem cell research in China–expected impact and challenges for implementation. Regen Med Doi:10.2217/rme.15.80. (This paper forms the basis for Sects. 13.4.4 and 13.5 of this chapter.) (This article has been published under a Creative Commons CC-BY license, and we are allowed to use published this information in this chapter.)
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- 2.
Please note that the Chinese Ministry of Health (MOH) was in 2012 renamed to the National Health and Family Planning Commission (NHFPC). In this article we use both of these terms: for regulatory documents that were issued before 2012, we use the term Ministry of Health (MOH), and for regulatory documents that were issued after 2012, we use the term National Health and Family Planning Commission (NHFPC).
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Please note that the Chinese State Food and Drug Administration (SFDA) was in 2012 renamed to the China Food and Drug Administration (CFDA). In this article we use both of these terms: for regulatory documents that were issued before 2012, we use the term State Food and Drug Administration (SFDA), and for regulatory documents that were issued after 2012, we use the term China Food and Drug Administration (CFDA).
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This document has been put on the MOH website. http://61.49.18.65/publicfiles///business/cmsresources/mohkjjys/cmsrsdocument/doc13829.docx. Translations of these two documents can be requested from the author of this article per email.
References
Azuma K (2015) Regulatory landscape of regenerative medicine in Japan. Curr Stem Cell Rep 1(11):118–128
Chen H (2009) Stem cell governance in China: from bench to bedside? New Genet Soc 28(3):267–282
CURE (2009) Medical research council: CURE committee report. URL: http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC006303. Accessed 22 Dec 2015
Cyranoski D (2012) China’s stem cell rules go unheeded. Nature 484(7393):149–150
Hu QL, Liu M, Wei Z (2011) Introduction of ethics committees in China. Humboldt University, Charite Campus, SIGENET Health China Week, Berlin
ISSCR (2008) Guidelines for the clinical translation of stem cells. http://www.isscr.org/docs/guidelines/isscrglclinicaltrans.pdf. Accessed 22 Dec 2015
Knoepfler PS (2014) From bench to FDA to bedside: US regulatory trends for new stem cell therapies. Adv Drug Deliv Rev 82:192–196
McMahon D, Thorsteinsdóttir H (2010) Regulations are needed for stem cell tourism: insights from China. Am J Bioeth 10(5):34–36
McMahon DS (2014) The global industry for unproven stem cell interventions and stem cell tourism. Tissue Eng Regen Med 11(1):1–9
Rosemann A (2013) Medical innovation and national experimental pluralism: insights from clinical stem cell research and applications in China. BioSocieties 8(1):58–74
Song P (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation. New Genet Soc 30(2):141–153
Sui S, Sleeboom-Faulkner M (2015) Governance of stem cell research and its clinical translation in China: an example of profit-oriented bionetworking. East Asian Sci Technol Soc 9:397–412. doi:10.1215/18752160-3316753
Xinhua (2013) China to further regulate stem cell clinical experiments. http://news.xinhuanet.com/english/sci/2013-03/07/c_132216784.htm. Accessed 22 Dec 2015
Yuan W, Sipp D, Wang ZZ, Deng H, Pei D, Zhou Q, Cheng T (2012) Stem cell science on the rise in China. Cell Stem Cell 10(1):12–15
Zhai XM (2007) Challenges and governance/regulatory responses in china. In conference paper, BIONET workshop, Shanghai
Zhang JY (2012) The cosmopolitanization of science: stem cell governance in China. Palgrave MacMillan, London
Zornoza L (2013) China proposes stem cell clinical trial rules. Website of Regulatory Focus, http://www.raps.org/focus-online/news/news-article-view/article/2983/china-proposes-stem-cell-clinical-trial-rules.aspx. Accessed 22 Dec 2015
Acknowledgments
This article has benefited from research support provided by the European Research Council (ERC, 283219) and the Economic and Social Science Research Council (ESRC, ES/I018107/1). Due to ethical concerns, supporting data cannot be made openly available.
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Rosemann, A., Sleeboom-Faulkner, M., Zhang, X., Sui, S., Ely, A. (2017). The Regulatory Situation for Clinical Stem Cell Research in China. In: Pham, P., Rosemann, A. (eds) Safety, Ethics and Regulations. Stem Cells in Clinical Applications. Springer, Cham. https://doi.org/10.1007/978-3-319-59165-0_13
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