Establishing a regulatory framework for phage therapy in China
Peer-Reviewed Publication
Updates every hour. Last Updated: 28-Oct-2026 20:16 ET (29-Oct-2026 00:16 GMT/UTC)
The growing threat of antimicrobial resistance (AMR) calls for effective solutions such as phage therapy. In China, phage therapy has been implemented in over 30 hospitals, treating more than 500 patients with multidrug-resistant infections. Phage therapy can currently be developed through two pathways: as a novel biomedical technology or as a new drug. However, regulatory ambiguity persists due to a lack of standardized quality criteria and clear approval frameworks. This article proposes a "standards first, pathway pilots, and industry cultivation" strategy. Key recommendations include developing national quality control guidelines for therapeutic phage preparations and clarifying the detailed guidelines for approval policies for new biomedical technologies, biologics, and advanced therapy medicinal products (ATMPs). These efforts aim to enable safe and effective clinical translation, positioning China as a frontrunner in phage therapy and making significant contributions to the global response against AMR.
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