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Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations

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posted on 2023-06-09, 02:33 authored by Achim Rosemann, Gaby Bortz, Federico Vasen, Margaret Sleeboom-FaulknerMargaret Sleeboom-Faulkner
In 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 Medicine

ISSN

1746-0751

Publisher

Future Medicine

Issue

7

Volume

11

Page range

647-657

Department affiliated with

  • Anthropology Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-08-15

First Open Access (FOA) Date

2016-08-16

First Compliant Deposit (FCD) Date

2016-08-16

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