Supporting Filing Guidance under Order No. 818
Filing Guidline on Clinical Research of Phage Therapy New Biomedical Technologies (Version 1) applies to phage therapy clinical translation 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, the preparation and quality control of investigational products, non-clinical research, clinical research, and ethical compliance.
Supporting Operational Specifications for Translation Approval under Order No. 818
The Regulations on the Administration of Clinical Research and Translational Application of New Biomedical Technologies mainly covering 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 State Council Order No. 818, promulgating the Regulations on the Administration of Clinical Research and Clinical Translation Application of Biomedical New Technologies, which will come into effect on May 1, 2026. The Regulations specify the pathways for clinical research and clinical translation 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 translated 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 Translation and Application of NBMT marks the imminent implementation of detailed, end-to-end rules for conducting clinical research and translation 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
Translational Approval Original Link
https://www.nhc.gov.cn/kjjys/c100016/202604/6d64fdc552ee49f4abba44831d189201.shtml
Translational Approval File Downloads
- Application Form for Clinical Translation and Application of New BiomedicalTechnologies.docx
- Requirements for Formal Review of Application for Clinical Translation and Application of New Biomedical Technologies.docx
- Application Form for Priority Review and Approval of Clinical Translation and Application of New Biomedical Technologies.docx
