INFLUENCING FACTORS ON THE APPROVAL LAG FOR INNOVATIVE DRUGS IN CHINA
Author(s)
Pei Wang, doctoral student, Wei Huang, Master's degree student, MING HU, PhD;
Sichuan University, Chengdu, China
Sichuan University, Chengdu, China
OBJECTIVES: This study examines the length of time to approval for innovative drugs in China and the determinants associated with them following the formal implementation of accelerated registration pathways in 2020.
METHODS: Retrospective collection of information on innovative drugs approved for market release from January 2021 to December 2024. Inclusion criteria: (1) Category 1 chemical drugs and biological products under China’s drug registration classification; (2) Complete review timelines (duration of the initial review round, total review duration, and total time to market) and characteristic information (drug classification, therapeutic area, clinical trials, and approval pathway). Univariate analysis employed the Mann-Whitney U test and Spearman correlation analysis. Variables showing statistically significant differences in univariate analysis were incorporated into a multiple linear regression model to examine factors influencing the three types of timelines.
RESULTS: A total of 121 innovative drugs were included, with the highest number approved in 2024 (n=45). Among these, 47.93% were anticancer drugs, and over half (53.72%) were included in at least one accelerated registration pathway. The first-round review duration was 0.59 (interquartile range [IR]: 0.48-0.74) years, the total review duration was 1.32 (IR: 1.07-1.64) years, and the total time to market was 6.84 (IR: 4.92-9.08) years. Accelerated registration pathways (p<0.001) and anti-tumor indications (p<0.05) are factors that expedite the initial review duration, with accelerated registration pathways (p<0.05) significantly reducing the total review time. Number of supplementary materials provided (p<0.001) extend the total review duration. For the total time to market, the clinical trial approval pathway (p<0.001) acts as a delaying factor.
CONCLUSIONS: The implementation of accelerated registration pathways has effectively mitigated the approval lag for innovative drugs, thereby enhancing patient access to new therapies. To build on this progress, further efforts could focus on streamlining clinical trial approval procedures and expediting the overall regulatory review process.
METHODS: Retrospective collection of information on innovative drugs approved for market release from January 2021 to December 2024. Inclusion criteria: (1) Category 1 chemical drugs and biological products under China’s drug registration classification; (2) Complete review timelines (duration of the initial review round, total review duration, and total time to market) and characteristic information (drug classification, therapeutic area, clinical trials, and approval pathway). Univariate analysis employed the Mann-Whitney U test and Spearman correlation analysis. Variables showing statistically significant differences in univariate analysis were incorporated into a multiple linear regression model to examine factors influencing the three types of timelines.
RESULTS: A total of 121 innovative drugs were included, with the highest number approved in 2024 (n=45). Among these, 47.93% were anticancer drugs, and over half (53.72%) were included in at least one accelerated registration pathway. The first-round review duration was 0.59 (interquartile range [IR]: 0.48-0.74) years, the total review duration was 1.32 (IR: 1.07-1.64) years, and the total time to market was 6.84 (IR: 4.92-9.08) years. Accelerated registration pathways (p<0.001) and anti-tumor indications (p<0.05) are factors that expedite the initial review duration, with accelerated registration pathways (p<0.05) significantly reducing the total review time. Number of supplementary materials provided (p<0.001) extend the total review duration. For the total time to market, the clinical trial approval pathway (p<0.001) acts as a delaying factor.
CONCLUSIONS: The implementation of accelerated registration pathways has effectively mitigated the approval lag for innovative drugs, thereby enhancing patient access to new therapies. To build on this progress, further efforts could focus on streamlining clinical trial approval procedures and expediting the overall regulatory review process.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR97
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas