Many 'rising powers' such as India, China, Argentina, Singapore, and Brazil are investing in stem cell technology, joining the traditional leaders in the field, such as the UK, Germany, USA, and Japan. Malaysia is also entering this sector because of the potential medical and economic benefits that the use of stem cell technologies could provide. Like other countries, Malaysia faces the challenge of how to encourage scientific progress and innovation in an ethical manner while at the same time ensuring a safe and accessible market for regenerative therapies. This paper reports on the research findings of semi-structured interviews with local stakeholders to investigate how they perceived and evaluated the current regulatory framework for human stem cell research in Malaysia, and what might be at stake if the state continues with its current regulatory approach.

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Malaysia aspires to develop regenerative medicine through stem-cell technology. It needs a regulatory system that could facilitate development and prevent unethical practices. A comparative legal analysis on the regulation of stem-cell technology, with a focus on stem-cell research in Malaysia and selected Commonwealth countries that are experienced in regulating this complex technology, demonstrates that the selected Commonwealth countries have adopted a hybrid of different regulatory mechanisms. This paper argues that Malaysia should consider adopting a similar approach to equip relevant authorities with different regulatory mechanisms that are able to promote innovation in stem-cell research activities and cultivate a successful and profitable regenerative medicine industry in the future. Such a strategic action can produce an optimal regulatory outcome and help Malaysia to realize its aspiration.