Presentation (CTI)

OBJECTIVES: China has undergone a profound transformation over the past decade, evolving from a predominantly generic-focused market into the world's second-largest pharmaceutical industry, accounting for approximately 30% of global innovative drugs in development. Historically characterised by significant drug lag and limited reimbursed access, China's market access environment has shifted markedly, driven by concurrent regulatory, reimbursement, and procurement reforms. This study provides an overview of key policy developments shaping China's emergence as a major global pharmaceutical launch market.
METHODS: A targeted landscape review of regulatory guidance, national policy documents, grey literature, and peer-reviewed studies was conducted. The analysis focused on three dimensions: (1) regulatory pathway reforms under the National Medical Products Administration (NMPA); (2) evolution of the National Reimbursement Drug List (NRDL) negotiation process; and (3) the impact of Volume-Based Procurement (VBP) on the innovative medicines landscape.
RESULTS: Since joining the International Council for Harmonisation in 2017, China has accelerated approvals; Innovative drug approvals increased from 48 in 2024 to a record high 76 in 2025 (+58%). A 30-day clinical trial review channel introduced in September 2025 further compresses timelines. The 2025 NRDL negotiations listed 114 drugs, with 88% of those entering formal price negotiations securing inclusion, the highest on record, including 50 Class I innovative drugs and the inaugural Commercial Insurance Innovative Drug List. VBP's 11^th round, covering 55 drugs, may further strengthen incentives for innovation. Collectively, these reforms strengthen China’s domestic launch and access environment through faster regulatory pathways, broader reimbursement channels, and more structured pricing and procurement mechanisms.
CONCLUSIONS: China’s reforms have elevated the country to a higher priority launch market. As its strategic importance continues to increase, China is likely to assume a larger role in manufacturers’ global launch-sequencing decisions and to compete more directly with other priority markets for launch timing and investment.