China's State Council has released the National Health 15th Five-Year Plan, elevating support for innovative drugs and medical devices to a top-level strategic priority. Distinct from the 14th Five-Year Plan, the document explicitly shifts focus toward original innovation – moving references to generic drugs under Food and Drug Safety Improvement rather than innovation incentives – and introduces the «establishment of a comprehensive clinical evaluation system for innovative drugs» to tackle hospital access barriers.

Despite national reimbursement via negotiation, data show average tertiary hospital adoption rates for negotiated innovative drugs were only ~10.7% between 2010 and mid-2024, limiting clinical accessibility. A unified evaluation framework aims to provide institutional support for evidence-based formulary inclusion and clinical uptake.

The plan also names specific frontier modalities – cell and gene therapies, novel antibodies, vaccines, nucleic acid drugs, and radiopharmaceuticals – while mandating AI integration across the health-industrial chain, including a national pilot base for medical AI applications. This complements a 2026 policy wave: the revised Drug Administration Law Implementation Regulations (effective May 2026) formalising four accelerated pathways (breakthrough, conditional approval, priority review, special approval), overseas data reciprocity, and paediatric/rare disease market exclusivity; the Drug Trial Data Protection Measures (June 2026) granting up to six years' data protection for imported originators; CDE's Rare Disease Care Plan-Extension; and pricing/commercialisation reforms allowing self-assessed innovative drug pricing and a new commercial health insurance innovative drug catalogue.

Together, these measures construct a full-cycle incentive structure – from R&D protection to rational pricing and multi-payer access – reducing policy uncertainty for genuinely differentiated innovation.