Reg Med Rosemann et al. - accepted version.pdf (233.34 kB)
Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations
journal contribution
posted on 2023-06-09, 02:33 authored by Achim Rosemann, Gaby Bortz, Federico Vasen, Margaret Sleeboom-FaulknerMargaret Sleeboom-FaulknerIn this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.
Funding
Bionetworking in Asia - International collaboration, exchange, and responsible innovation in the life sciences; G0750; ESRC-ECONOMIC & SOCIAL RESEARCH COUNCIL; ES/I018107/1
Bionetworking in Asia - A social science approach to international collaboration, informal exchanges, and responsible innovation in the life sciences; G0812; EUROPEAN UNION; 283219
History
Publication status
- Published
File Version
- Accepted version
Journal
Regenerative MedicineISSN
1746-0751Publisher
Future MedicineExternal DOI
Issue
7Volume
11Page range
647-657Department affiliated with
- Anthropology Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2016-08-15First Open Access (FOA) Date
2016-08-16First Compliant Deposit (FCD) Date
2016-08-16Usage metrics
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