Regulatory reforms and the impact on overseas new drug accessibility in China: an analysis from 2010 to 2025
- 1School of Business Administration, Shenyang Pharmaceutical University
Abstract
In recent years, China has undertaken a series of regulatory reforms aimed at enhancing the accessibility of overseas new drugs by mitigating marketing approval lag and expediting their inclusion in the National Reimbursement Drug List (NRDL). This study conducted a retrospective analysis of overseas new drugs approved in China between 2010 and 2025, emphasizing temporal shifts in drug characteristics, regulatory efficiency, and approval lag across different reform periods. Furthermore, the study examined the reimbursement status of overseas new drugs in China, identified factors influencing their inclusion in the NRDL, and explored the China-oriented research and development (R&D) strategies adopted by their holders. Following the implementation of these reforms, the number of overseas new drug approvals increased significantly, with the cumulative total reaching 361 over the 2010–2025 study period. Simultaneously, the approval lag of overseas new drugs in China experienced a reduction, with the median duration decreasing from 1,442 to 1,188 days, using the United States as a reference. Notable improvements were observed in reimbursement access, as 213 out of 361 drugs (59.0%) were incorporated into the NRDL, and the median time for inclusion in the NRDLs was reduced from 2,297 to 743 days. However, we found that drugs approved after the reforms did not have a significantly higher likelihood of being included in the NRDL. Analyses specific to different R&D strategies indicated greater regulatory flexibility in China’s acceptance of overseas clinical evidence. Notably, drugs participating in multi-regional clinical trials (MRCTs) were associated with the shortest median approval lag, measured at 737.5 days. Overall, these findings highlighted the critical importance of China’s integration into global drug development initiatives and the need for enhanced coordination between regulatory and reimbursement processes.
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BibTeX
@article{tang2026regulatory,
title = {{Regulatory reforms and the impact on overseas new drug accessibility in China: an analysis from 2010 to 2025}},
author = {Yaoyang Tang and Li Yang},
journal = {Frontiers in Pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1961582},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1961582/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Regulatory reforms and the impact on overseas new drug accessibility in China: an analysis from 2010 to 2025
AU - Yaoyang Tang
AU - Li Yang
PY - 2026
DA - 2026/10/16
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1961582
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1961582/full
AB - In recent years, China has undertaken a series of regulatory reforms aimed at enhancing the accessibility of overseas new drugs by mitigating marketing approval lag and expediting their inclusion in the National Reimbursement Drug List (NRDL). This study conducted a retrospective analysis of overseas new drugs approved in China between 2010 and 2025, emphasizing temporal shifts in drug characteristics, regulatory efficiency, and approval lag across different reform periods. Furthermore, the study examined the reimbursement status of overseas new drugs in China, identified factors influencing their inclusion in the NRDL, and explored the China-oriented research and development (R&D) strategies adopted by their holders. Following the implementation of these reforms, the number of overseas new drug approvals increased significantly, with the cumulative total reaching 361 over the 2010–2025 study period. Simultaneously, the approval lag of overseas new drugs in China experienced a reduction, with the median duration decreasing from 1,442 to 1,188 days, using the United States as a reference. Notable improvements were observed in reimbursement access, as 213 out of 361 drugs (59.0%) were incorporated into the NRDL, and the median time for inclusion in the NRDLs was reduced from 2,297 to 743 days. However, we found that drugs approved after the reforms did not have a significantly higher likelihood of being included in the NRDL. Analyses specific to different R&D strategies indicated greater regulatory flexibility in China’s acceptance of overseas clinical evidence. Notably, drugs participating in multi-regional clinical trials (MRCTs) were associated with the shortest median approval lag, measured at 737.5 days. Overall, these findings highlighted the critical importance of China’s integration into global drug development initiatives and the need for enhanced coordination between regulatory and reimbursement processes.
SN - 1663-9812
ER -