Breaking the upper limit of innovation: China's dual-track regulatory framework for emerging biomedical innovations
Global biomedical governance is undergoing a notable shift, marked by the growing divergence between established Western regulatory models and emerging dual-track frameworks in East Asia. For decades, the “gold standard” of biomedical regulation has been defined by the centralized, precautionary regimes of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), prioritizing safety through stringent pre-market authorization. While minimizing risk, these models are increasingly criticized for “drug lag,” delaying patient access to evolving therapies.
Conversely, the dual-track model attempts to accelerate the development of biomedical innovations such as gene and cell therapies (GCTs) by institutionalizing a parallel pathway outside traditional pharmaceutical pipelines. By allowing accredited entities to develop and apply novel biomedical technologies (NBTs) through a hospital-based track, this approach seeks to overcome long-standing bottlenecks inherent in pre-market approval systems.
On September 28, 2025, China promulgated the “Regulation on the Administration of Clinical Research and Clinical Translational Application of Novel Biomedical Technologies” (“Order No. 818”), a landmark statute scheduled to enter into force on May 1, 2026. This Order represents China’s most definitive regulatory position on NBTs. In this commentary, we examine how Order No. 818 extends the upper limits of China’s promissory regulatory framework and identify key challenges that may shape its future implementation.
Regulatory approaches to NBTs can be situated along a continuum between precautionary and promissory orientations. Precautionary approaches emphasize uncertain risks, whereas promissory approaches foreground potential benefits. Over the past decade, a combination of factors, including the urgency of addressing unmet clinical needs, ambitions to enhance the global competitiveness of domestic biomedical industries, and, in some contexts, pressures from influential stakeholders, has driven many regulatory authorities toward a promissory approach.
The most common manifestation of this shift is the adoption of accelerated pathways, including shortened review timelines, early regulatory-scientific consultation, and conditional authorizations based on preliminary clinical evidence. These mechanisms aim to expedite patient access to promising therapies. In China, such pathways can reduce market entry time from over 6 years to 3. Yet even under accelerated models, patient use ultimately requires market authorization—or, in narrowly defined exceptional circumstances, being under review for such authorization.
