Drug or Medical Technology? China’s Dual-Track Regulation of Cell and Gene Therapy under State Council Order No. 818

Whether a cell or gene therapy (CGT) is regulated as a drug or as a medical technology determines who approves it, on what evidence, and at what cost. China answers this question with a dual-track system. On May 1, 2026, China's Regulation on the Clinical Research and Translational Application Management of New Biomedical Technologies (State Council Order No. 818) took effect, giving that system its most authoritative legislative form to date, supplemented by three implementing instruments issued in April 2026. The first track regulates CGT as a biologic under the National Medical Products Administration (NMPA). The second regulates it as a medical technology under the National Health Commission (NHC) and contains two subtypes that the law now separates explicitly: non-commercial investigator-initiated research (Article 20), in which participants cannot be charged, and fee-charging translational application (Article 34). Building on earlier accounts of China's system, and drawing on the Regulation and its implementing documents, this Perspective clarifies the dual-track architecture and sets it beside the regenerative-medicine frameworks of Japan, Korea, the European Union, and the United States. Compared this way, China's drug track is conventional by international standards. Its medical-technology track is the distinctive part: a statutory line between non-commercial research and fee-charging application (Articles 20 and 34); a risk-tiered period that confines a newly approved technology to its originating institutions for five, three, or one year; and a published, rule-based classification mechanism under Article 55, operated through a positive list with sponsor self-classification, NHC advisory support, and joint NHC–NMPA deliberation when the list is revised. For readers abroad, the practical point is that the track on which a Chinese study sits is part of how its evidence should be read.