Annotation

Purpose: analysis of changes in the regulation system of bio-law and bioethics in China in the context of socially significant cases of ethical violations in recent years (the He Jiankui case), as well as the impact of implemented changes at the formal legal level on their further regulation. Determining the sufficiency of existing legislation and upcoming changes in Chinese legislation in the field of bioethics in the context of strengthening the significance and effectiveness of bioethical regulation. Methods: general scientific methods (analysis, synthesis, systematic approach); specific legal methods (comparative legal, formal legal, historical legal, system-structural). Results: the legal regulation of bioethics and bio-law in China is based on framework constitutional norms that adapt international principles to national priorities, including ensuring state security. The development of legislation in this area is largely reactive in nature, with the He Jiankui case being the key trigger, which led to the adoption of the 2021 Biosecurity Law and strengthened centralization of management. A significant problem remains the uncertainty regarding the legal status and legal force of decisions made by bioethics committees, which creates risks for the effectiveness of ethical control. The adoption of the State Council Decree No. 818 (2026) marks a transition to more systematic regulation, introducing clear procedures, enhanced researcher responsibility, and a strive for balance between innovation and ethical imperatives. Discussion: the article aims to provide a comprehensive analysis of the evolution of legal regulation of bioethics in China – from fragmented norms to the construction of a centralized system amid strategic challenges. The research results can be used to improve national control mechanisms for biomedical research, as well as to minimize legal risks for researchers and specialists in the field of international bio-law when interacting with the Chinese legal system.