Researchers at Shenyang Pharmaceutical University examined every overseas new drug approved in mainland China between January 2010 and December 2025, building a dataset of 361 therapeutic products that had either been marketed abroad or submitted for authorization outside the country before reaching the National Medical Products Administration (NMPA). Their retrospective analysis, published in Frontiers in Pharmacology, tracked how drug characteristics, regulatory efficiency, approval lag, and reimbursement access evolved across two distinct eras: the pre-reform period from 2010 to 2017 and the post-reform period from 2018 to 2025, with the dividing line anchored to China’s 2017 accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

The numbers tell a striking story of transformation. Annual approval counts remained low until 2017, dipping to just three drugs in 2016 after regulators cracked down on non-compliant clinical trial data, but rose markedly once the reform agenda took hold. The median review time fell from 532 days in the earlier period to 427 days afterward, and the median approval lag relative to the United States Food and Drug Administration shrank from 1,442 days to 1,188 days. The study also captured a dramatic shift in what kinds of medicines were coming through: biologics jumped from 13.4 percent of approvals before the reforms to 35.8 percent after, rare disease drugs climbed from 9.8 percent to 28.7 percent, and oncology products rose from 18.3 percent to 30.1 percent of the total.

Expedited regulatory pathways expanded in parallel. Before the reforms, only 19.5 percent of approved drugs carried at least one accelerated designation such as Priority Review, Conditional Approval, or Breakthrough Therapy Designation; afterward, that figure reached 58.1 percent. The number of source countries supplying approved drugs grew from 14 to 22, with the United States, Germany, and Japan leading the list. Yet despite this expansion, overseas innovative drugs accounted for just 9.1 percent of all approvals, suggesting that part of the post-reform surge reflected the clearance of a pre-existing application backlog rather than a flood of genuinely novel medicines.

The most technically revealing part of the analysis concerns how drug developers actually secured Chinese approval. The researchers classified 279 post-reform drugs into four research and development strategies: exclusive reliance on international clinical data without domestic trials; participation in multi-regional clinical trials that included China; international evidence supplemented by a bridging study; or additional China-specific pivotal trials. The differences were dramatic. Drugs developed through multi-regional trials enjoyed the shortest median approval lag at 737.5 days, with 5.1 percent actually approved in China before the United States and 27.6 percent within a year of American approval. By contrast, drugs requiring supplementary domestic trials faced a median delay of 2,066 days, and 79.2 percent of them arrived more than three years after FDA approval.

Exemption from domestic clinical trials, the strategy used predominantly for rare disease drugs and urgently needed overseas medicines, turned out to be a retrospective catch-up mechanism rather than a route to synchronized global development. Its median approval lag of 1,069 days was significantly longer than the multi-regional trial pathway, and none of the overseas innovative drugs used it. Bridging studies occupied a pragmatic middle ground with a median lag of 1,289.5 days, particularly common among oncology drugs where potential ethnic differences in drug metabolism can limit direct extrapolation of foreign evidence. The findings suggest that when multinational sponsors embed China early in global development programs, patients gain access years sooner than when evidence must be generated or supplemented domestically after the fact.

Reimbursement access improved even more dramatically than approval speed, but with an important caveat. Of the 361 drugs, 213, or 59 percent, had been incorporated into the National Reimbursement Drug List as of January 2026, and the median time from approval to inclusion plummeted from 2,297 days before the reforms to 743 days afterward. Yet the logistic regression analysis found that drugs approved after the reforms did not have a significantly higher likelihood of reimbursement inclusion, a paradox the authors attribute to unequal follow-up time rather than policy failure, since recently approved drugs have had fewer annual listing cycles in which to be considered. A sensitivity analysis using an alternative definition did find post-reform approval associated with increased odds of inclusion.

Several product characteristics consistently shaped reimbursement fortunes. Chemical drugs were more likely than biologics to make the list, with biologics showing 46 percent lower odds, likely reflecting their high treatment costs, substantial budget impact, and limited market competition. Oncology drugs had more than double the odds of inclusion, while drugs classified as urgently needed overseas medicines carried nearly triple the odds. Conversely, drugs indicated for pediatric patients and those granted conditional approval faced significantly lower odds, the latter presumably because approvals based on surrogate endpoints or immature clinical data complicate cost-effectiveness assessment. Rare disease drugs showed no significant reimbursement advantage despite their regulatory priority, a pattern the researchers link to sparse evidence from small patient populations.

The study’s authors argue that accelerating procedural timelines alone cannot overcome evidence-related barriers to coverage. They propose shifting reimbursement policy from one-time listing decisions toward a lifecycle-based evidence framework, in which initial coverage is linked to ongoing real-world evidence generation and subsequent reassessment. They also note that China has introduced its first Commercial Health Insurance Innovative Drug Catalog as a supplementary mechanism for innovative medicines outside basic insurance coverage, though translating catalog inclusion into effective patient access will require dynamic adjustment, tiered benefit design, and risk-sharing arrangements between insurers and manufacturers.

The broader lesson is that regulatory efficiency and reimbursement access are distinct hurdles that demand coordinated solutions. China’s integration into global drug development initiatives, particularly through early participation in multi-regional clinical trials, emerges as the single most powerful lever for shortening the wait for new medicines. Achieving near-synchronous approval with the United States and Europe will require earlier inclusion of China in global development programs, clearer pathways for using international evidence, and tighter alignment between the regulators who approve drugs and the payers who decide whether patients can actually afford them.

Subject of Research: Impact of China's 2010-2025 regulatory reforms on approval lag and reimbursement access for overseas new drugs

Article Title: Regulatory reforms and the impact on overseas new drug accessibility in China: an analysis from 2010 to 2025

Article References: Regulatory reforms and the impact on overseas new drug accessibility in China: an analysis from 2010 to 2025. (n.d.). https://doi.org/10.3389/fphar.2026.1961582

Image Credits: AI Generated

DOI: 10.3389/fphar.2026.1961582

Keywords: China, drug regulation, NMPA, approval lag, National Reimbursement Drug List, multi-regional clinical trials, rare disease drugs, oncology, biologics, reimbursement policy, drug accessibility, ICH harmonization