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New regulation for clinical stem cell research in China : expected impact and challenges for implementation
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Rosemann, Achim and Sleeboom-Faulkner, Margaret (2015) New regulation for clinical stem cell research in China : expected impact and challenges for implementation. Regenerative Medicine, 11 (1). pp. 5-9. ISSN 1746-0751.
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Official URL: https://doi.org/10.2217/rme.15.80
Abstract
On August 22, 2015 the Chinese National Health and Family Planning Commission (NHFPC, the former Ministry of Health, MOH) have issued the long awaited “draft” regulation on clinical research and applications that involve human stem cells [1] [2] [3]. In China, regulation usually starts out as a draft (草案) or trial regulation (试行). A draft regulation should be regarded as valid as formal regulation, but it is flexible enough to leave space for change. The document announces the central elements of a regulatory foundation for the clinical translation of stem cell-based medicinal products and procedures. What does China’s future regulation for clinical stem cell trials look like? What challenges can be expected with regard to its implementation? And what impacts will the regulation have for domestic researchers, clinics and corporations in China and at an international level?
Item Type: | Journal Article | ||||||
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Subjects: | Q Science > QH Natural history > QH426 Genetics | ||||||
Divisions: | Faculty of Social Sciences > Centre for Education Studies (2013- ) | ||||||
Library of Congress Subject Headings (LCSH): | Stem cells -- Research -- Law and legislation -- China, China. Guo jia wei sheng he ji hua sheng yu wei yuan hui | ||||||
Journal or Publication Title: | Regenerative Medicine | ||||||
Publisher: | Future Medicine | ||||||
ISSN: | 1746-0751 | ||||||
Official Date: | 18 December 2015 | ||||||
Dates: |
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Volume: | 11 | ||||||
Number: | 1 | ||||||
Page Range: | pp. 5-9 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 25 August 2017 | ||||||
Date of first compliant Open Access: | 25 August 2017 | ||||||
Funder: | European Research Council (ERC), Economic and Social Research Council (Great Britain) (ESRC) | ||||||
Grant number: | Grant No. 283219 (ERC), ES/I018107/1 (ESRC) |
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