作者
Achim Rosemann, Gabriela Bortz, Federico Vasen, Margaret Sleeboom-Faulkner
发表日期
2016/10
来源
Regenerative medicine
卷号
11
期号
7
页码范围
647-657
出版商
Future Medicine Ltd
简介
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.
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