The field of regenerative medicine (RM) stands at the precipice of significant breakthroughs in medical science, including developing innovative treatments for degenerative diseases, genetic disorders, and organ failure. However, research and development in the field raises pressing ethical and legal concerns surrounding patient safety, obtaining informed consent, and ensuring equitable access to innovative treatments. China is an important player in the stem cell research and RM space and has implemented various policies to promote biomedical advances. These policies have included the establishment of strong governance measures and related laws to address contentious ethical and legal issues associated with the development of novel therapies. This chapter explores policies and regulatory frameworks that serve to advance RM in China. This chapter will examine key challenges, including issues related to bioethical governance, regulatory gaps, and legal barriers to international cooperation within the field of RM. We will then assess China’s proactive measures and current challenges for addressing disparities in access to RM technologies in low- and middle-income countries (LMICs) and outline directions for the country’s future efforts to promote a balanced global approach, one that fosters international collaboration, including fair genomic data sharing, to enhance the global availability and affordability of RM products.

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Regenerative Medicine in China: Current Regulatory Challenges and Global Advancements

  • Meng Wang,
  • Li Du

摘要

The field of regenerative medicine (RM) stands at the precipice of significant breakthroughs in medical science, including developing innovative treatments for degenerative diseases, genetic disorders, and organ failure. However, research and development in the field raises pressing ethical and legal concerns surrounding patient safety, obtaining informed consent, and ensuring equitable access to innovative treatments. China is an important player in the stem cell research and RM space and has implemented various policies to promote biomedical advances. These policies have included the establishment of strong governance measures and related laws to address contentious ethical and legal issues associated with the development of novel therapies. This chapter explores policies and regulatory frameworks that serve to advance RM in China. This chapter will examine key challenges, including issues related to bioethical governance, regulatory gaps, and legal barriers to international cooperation within the field of RM. We will then assess China’s proactive measures and current challenges for addressing disparities in access to RM technologies in low- and middle-income countries (LMICs) and outline directions for the country’s future efforts to promote a balanced global approach, one that fosters international collaboration, including fair genomic data sharing, to enhance the global availability and affordability of RM products.