NHC Issues the Work Rules for the Approval of Clinical Translational Application of New Biomedical Technologies

The National Health Commission (NHC) has released the Work Rules for the Approval of Clinical Translational Application of New Biomedical Technologies (for Trial Implementation) (the "Rules"), effective from May 1, 2026.

The Rules consist of 26 articles in five chapters. Chapter I, General Provisions, clarifies the purpose and legal basis, scope of application, scope of approval, approval principles, and management responsibilities. Chapter II, Application and Acceptance, sets forth the conditions for applying for the clinical translational application of new biomedical technologies, application materials, and procedures for formal review and acceptance. Chapter III, Review and Decision, addresses the review method combining expert evaluation with departmental examination, details the core approval procedures such as verification of materials, technical and ethical evaluation, and the formation of licensing decisions, and specifies special approval channels such as priority review and approval and emergency application. Chapter IV, Clinical Application Management, provides the rules for the management of clinical applications after approval of new biomedical technologies, medical quality and safety management, reporting on application status, re-evaluation, as well as supervision and administration.



(Source: https://www.nhc.gov.cn/qjjys/c100016/202604/6d64fdc552ee49f4abba44831d189201.shtml)

Note: The link to the Chinese official website of the document is for your reference.