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Groundbreaking: China's Filing Guidance and Conversion Approval Regulations under Order No. 818 Officially Released — Marking the Nation's First National-Level Guidelines for Phage Therapy
Date：2026-05-18
Supporting Filing Guidance under Order No. 818
Filing Guidance for Clinical Research on Novel Phage Therapy Technologies (Version 1) is applicable to phage therapy clinical transformation research conducted within China that is not intended for drug registration purposes. It primarily provides technical guidance and basic requirements for relevant studies, focusing on the qualifications of filing institutions and researchers, preparation and quality control of investigational products, non-clinical research, clinical research, and ethical compliance.
Supporting Operational Specifications for Transformation Approval under Order No. 818
Operational Specifications for the Approval of Clinical Transformation and Application of Biomedical New Technologies (Trial) consists of five chapters and twenty‑six articles, mainly including general provisions, application and acceptance, review and decision, clinical application management, and supplementary provisions. The document defines the scope of approval, approval principles, and management responsibilities; specifies application conditions, application materials, and the procedures for formal review and acceptance; clarifies a review mechanism combining expert evaluation and departmental review; and sets forth requirements for post‑approval clinical application management, reporting on application status, re‑evaluation, and supervision.
Relevant Background
On October 10, 2025, Premier Li Qiang of the State Council signed Order No. 818 of the State Council, promulgating the Regulations on the Administration of Clinical Research and Clinical Transformation Application of Biomedical New Technologies, which will come into effect on May 1, 2026. The Regulations specify the pathways for clinical research and clinical transformation application of biomedical new technologies: after completing non‑clinical research and passing academic review and ethical review, a filing for clinical research may be submitted to the health department under the State Council; technologies proven safe and effective through clinical research may be transformed and applied in clinical practice only after approval. In addition, the Regulations set forth provisions on the whole‑process management of clinical research, risk control, and protection of the rights and interests of research participants.
The official release of the above‑mentioned Filing Guidance and the Operational Specifications for the Approval of Clinical Transformation and Application of Biomedical New Technologies (Trial) marks the imminent implementation of detailed, end‑to‑end rules for conducting clinical research and transformation of biomedical new technologies.
Original Links and File Downloads
Filing Guidance Original Link
https://www.cncbd.org.cn/TColumn/Detail/14511
Filing Guidance File Download
Filing Guidance for Clinical Research on Novel Phage Therapy Technologies.pdf
Transformation Approval Original Link
https://www.nhc.gov.cn/kjjys/c100016/202604/6d64fdc552ee49f4abba44831d189201.shtml
Transformation Approval File Downloads
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