Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024

Following the implementation of drug regulatory reforms in China, expedited programs have been established to accelerate drug development, review, and approval for marketing. This study examined a sample of 302 oncology indications approved by the National Medical Products Administration (NMPA) to explore the relationship between indication characteristics, pivotal clinical trial features, clinical benefit, and the cumulative number of expedited program designations. Furthermore, the study evaluated the actual execution of these expedited programs in China by assessing the clinical development time and review time of the approvals for oncology indications. Indications that received a higher cumulative number of expedited program designations generally exhibit higher innovation, lower pivotal clinical trial quality, greater clinical benefit, and reduced clinical development time and review time. Within these expedited programs, the implementation of Conditional Approval (CA) was pivotal in shortening the clinical development time, while Priority Review (PR) contributed to a reduction in review time. However, no significant impact of Breakthrough Therapy Designation (BTD) on the drug development process was observed. The simultaneous implementation of multiple expedited programs has been shown to be more effective in decreasing both clinical development and review times. While the implementation of expedited programs in China has yielded preliminary outcomes, it is imperative for regulatory authorities to further refine the legal and regulatory frameworks associated with these programs, addressing any deficiencies arising from their implementation.