New regulation-Rosemann.pdf (1.2 MB)
New regulation for clinical stem cell research in China: expected impact and challenges for implementation
journal contribution
posted on 2023-06-08, 23:47 authored by Achim Rosemann, Margaret Sleeboom-FaulknerMargaret Sleeboom-FaulknerOn 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 (??) or trial regulation (??). 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?
Funding
Bionetworking in Asia: Biomaterials and Cell Bank Regimes; ERC; 283219
Bionetworking in Asia: Patient Recruitment & Therapy Practices; ESRC; ES/I018107/1
History
Publication status
- Published
File Version
- Published version
Journal
Regenerative MedicineISSN
1746-0751Publisher
Future MedicineExternal DOI
Issue
1Volume
11Page range
5-9Department affiliated with
- Anthropology Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2015-12-21First Open Access (FOA) Date
2016-08-16First Compliant Deposit (FCD) Date
2016-08-16Usage metrics
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