New regulation for clinical stem cell research in China: expected impact and challenges for implementation

Rosemann, Achim and Sleeboom-Faulkner, Margaret (2016) 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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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: Article
Keywords: China, clinical translation, international harmonization, life science governance, new regulation, stem cell research
Schools and Departments: School of Global Studies > Anthropology
Subjects: R Medicine > RA Public aspects of medicine > RA0001 Medicine and the state. Including medical statistics, medical economics, provisions for medical care, medical sociology
R Medicine > RA Public aspects of medicine > RA0001 Medicine and the state. Including medical statistics, medical economics, provisions for medical care, medical sociology > RA0399 Regulation of medical practice. Evaluation and quality control of medical care. Medical audit
Depositing User: Achim Rosemann
Date Deposited: 21 Dec 2015 09:05
Last Modified: 10 Mar 2017 14:37
URI: http://sro.sussex.ac.uk/id/eprint/58890

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Project NameSussex Project NumberFunderFunder Ref
Bionetworking in Asia: Biomaterials and Cell Bank RegimesUnsetERC283219
Bionetworking in Asia: Patient Recruitment & Therapy PracticesUnsetESRCES/I018107/1