Abstract

While existing literature often portrays China’s human genetic resource (HGR) regulations as primarily restrictive, this report demonstrates their evolution towards a more sophisticated and balanced framework. First, China’s transition from addressing biopiracy to incorporating HGR management into national security frameworks reflects a reconceptualization of genetic resources as strategic assets. Second, regulatory changes since 2023 show increasing flexibility in international collaboration, particularly in clinical trials, whilst maintaining protective measures. Third, regarding ethical management, the absence of clear legal distinctions between HGRs at the natural state and processed cellular products may negatively affect biotech industry development, while donors’ property rights over their genetic resources remain unsettled. These findings demonstrate how China has continuously refined its HGR regulatory framework to protect national interests whilst advancing innovation and international scientific cooperation.