Despite promises of improved diagnostic and therapeutic methods for diseases without effective existing treatments, disappointingly few regenerative medicines have entered the market, largely due to regulatory and ethical barriers. This chapter argues that South Africa must adopt an agile regulatory framework to balance innovation, commercialisation, and patient safety in the translation of regenerative medicine (RM). Although RM holds transformative potential for diseases lacking effective treatments, the country’s current legislative instruments, the National Health Act and the Medicines and Related Substances Act, fail to adequately address the unique scientific, ethical, and commercial complexities of RM, creating a regulatory vacuum that hinders innovation and oversight. As a result, local innovation is stifled, patients risk exposure to unproven therapies, and South Africa remains tethered to Global North regulatory paradigms that do not align with its socio-economic and healthcare realities. Through a comprehensive analysis of South Africa’s existing regulatory infrastructure, this chapter identifies key gaps, including ambiguous definitions, outdated approval processes, and ethical challenges around stem cell sourcing and clinical application. It further evaluates the benefits and limitations of adopting an agile regulatory framework informed by anticipatory, inclusive, and responsive governance practices. To address these gaps and limitations, the chapter recommends the development of RM-specific legislation, integration of international standards into local guidelines, public-private partnerships to fund innovation, and safeguards to prevent exploitative commercialisation. These actions aim to foster a regulatory environment conducive to responsible innovation while ensuring that regenerative treatments are accessible, affordable, and ethically governed.