Regulatory Review Time of Vaccine Approvals in China Between 2005 and 2024
Yingtian Ding, Mengyuan Fu, Reshma Ramachandran, Luwen Shi, Joseph S. Ross, Xiaodong Guan
TL;DR
This study analyzes how long it took for vaccines to be approved in China from 2005 to 2024.
Contribution
The study provides insights into regulatory timelines for vaccine approvals in China over two decades.
Findings
The study identifies trends in vaccine approval timelines.
It highlights variations in regulatory review durations across different periods.
Abstract
This cross-sectional study examines the regulatory review times for vaccine product applications submitted through China’s National Medical Products Administration over the past 2 decades.
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Figure| Stratified characterization | Applications, No. (%) | Length of review, median (IQR), d | |
|---|---|---|---|
| Total | 201 (100) | 576 (380-973) | NA |
| Manufacturer origin | |||
| Domestic | 163 (81.1) | 629 (379-1005) | .35 |
| Imported | 38 (18.9) | 503 (414-782) | |
| 4-y Interval | |||
| 2005-2008 | 71 (35.3) | 502 (355-741) | Reference |
| 2009-2012 | 39 (19.4) | 904 (471-1222) | .01 |
| 2013-2016 | 30 (14.9) | 978 (880-1296) | <.001 |
| 2017-2020 | 37 (18.4) | 502 (313-760) | .97 |
| 2021-2024 | 24 (11.9) | 464 (365-518) | .26 |
| Pathway | |||
| Standard review | 173 (86.1) | 576 (411-1005) | Reference |
| Priority review | 23 (11.4) | 629 (297-787) | .33 |
| Special approval | 5 (2.5) | 471 (161-660) | .32 |
| Conditional approval | 4 (2.0) | 8 (8-79) | .001 |
| Indication | |||
| Influenza | 33 (16.4) | 389 (307-471) | Reference |
| Epidemic encephalitis | 23 (11.4) | 879 (511-1191) | <.001 |
| Rabies | 22 (10.9) | 577 (436-1005) | .002 |
| Human papillomavirus | 17 (8.5) | 503 (439-643) | .06 |
| Myelitis | 13 (6.5) | 550 (486-684) | .11 |
| DPT | 9 (4.5) | 991 (441-1672) | .02 |
| Pneumonia | 9 (4.5) | 782 (634-1091) | .001 |
| H1N1 influenza | 8 (4.0) | 155 (111-49) | <.001 |
| HIB | 7 (3.5) | 737 (498-1216) | .003 |
| Chickenpox | 7 (3.5) | 702 (441-1294) | .02 |
| Enterovirus | 6 (3.0) | 700 (464-910) | .01 |
| Hepatitis B | 6 (3.0) | 434 (379-635) | .48 |
| Encephalitis B | 5 (2.5) | 745 (507-750) | .03 |
| Rotavirus | 4 (2.0) | 976 (882-1659) | .004 |
| Tetanus | 4 (2.0) | 669 (278-1507) | .53 |
| Kidney syndrome | 4 (2.0) | 1008 (806-1183) | .005 |
| Hepatitis A | 3 (1.5) | 1098 | .02 |
| Typhoid fever | 3 (1.5) | 1257 | .09 |
| Herpes zoster | 2 (1.0) | 223 | .10 |
| Cholera | 2 (1.0) | 891 | .06 |
| Ebola | 1 (0.5) | 161 | NA |
| Rubella | 1 (0.5) | 477 | NA |
| Concretion | 1 (0.5) | 1133 | NA |
| Lepra | 1 (0.5) | 719 | NA |
| MMR | 1 (0.5) | 859 | NA |
| Hepatitis E | 1 (0.5) | 660 | NA |
| COVID-19 | 1 (0.5) | 8 | NA |
| Pylori | 1 (0.5) | 676 | NA |
| Other combined vaccines | 6 (3.0) | 766 (502-1236) | NA |
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Taxonomy
TopicsVaccine Coverage and Hesitancy
Introduction
Prompt regulatory review for vaccine marketing applications is crucial to ensuring timely public access and preventing community transmission of infectious diseases. To accelerate review time frames, China’s National Medical Products Administration (NMPA) progressively introduced regulatory pathways, including special approval, priority review, and conditional approval, to speed review of marketing authorization applications (MAAs).^1^ To better understand these processes, we characterized regulatory review times for vaccine product applications submitted to NMPA over the past 2 decades.
Methods
This cross-sectional study was deemed exempt from review and informed consistent by the Peking University Health Science Center Institutional Review Board because no human participants or individual identifiers were involved. We followed the STROBE reporting guideline.
The study included all vaccine MAAs on the NMPA Center for Drug Evaluation (CDE) website between January 1, 2005, and December 31, 2024, identified using CDE coding principles for drug applications (eMethods in Supplement 1), including approved, declined, and still under review. The MAAs include initial vaccine, indication expansion, and change in administration route for approved vaccines. For each eligible MAA, vaccine indication, sponsor country of origin, application receipt date, approval date, and review pathway data were obtained from a commercial database and cross verified against records from CDE and NMPA.^2,3,4^
Regulatory review time was defined as the interval between NMPA application receipt and approval date. We used descriptive statistics to analyze review time by application year, review pathways, and sponsor country. Mann-Whitney U tests were performed to assess associations between each variable and review time. Significance was set at a 2-tailed P < .05. Analyses were performed using StataMP, version 18 (StataCorp LLC) and Python, version 3.11 (Vanderbilt University).
Results
Among 272 vaccine MAAs, 201 (73.9%) were approved, 39 (14.3%) were declined, and 32 (11.8%) remained under review. Of the 201 approved MAAs, 163 (81.1%) were domestically produced and 38 (18.9%) imported; moreover, 71 (35.3%) were submitted from 2005 to 2008. The proportion approved using expedited review pathways increased from 0% from 2005 to 2008 to 56.1% from 2017 to 2020 (Figure). The most common therapeutic categories were influenza (33 [16.4%]), epidemic encephalitis (23 [11.4%]), and rabies (22 [10.9%]).
Sankey Diagram for Vaccine Applications in China, 2005-2024
The median [IQR] review time for approved vaccine MAAs was 576 (380-973) days (Table). There were no significant review time differences between domestic (median [IQR], 629 [379-1005] days) and imported (median [IQR], 503 [414-782] days) vaccines. Review times fluctuated over 4-year intervals, with the shortest time recorded between 2021 and 2024 (median [IQR], 464 [365-518] days) and longest between 2013 and 2016 (median [IQR], 978 [880-1296] days). Compared with the standard review pathway (median [IQR], 576 [411-1005] days), conditional approval was associated with significantly shorter review times (median [IQR], 8 [8-79] days; P = .001) but were no different for priority review (median [IQR], 629 [297-787] days) and special approval (median [IQR], 471 [161-660] days).
Discussion
In this cross-sectional study of all vaccine MAAs by China’s NMPA from 2005 through 2024, median regulatory review times fluctuated but remained lengthy compared with international benchmarks, which were 6 months longer than the 12-month median review time for vaccines approved in the US between 2010 and 2020 and 2 months longer than the 16-month median for vaccines prequalified by the World Health Organization between 2009 and 2012.^5,6^ While vaccine manufacturer origin was not associated with review time, approval times using the conditional pathway were fastest. However, only 4 vaccines, for human papillomavirus, herpes zoster, and COVID-19, received conditional approval over the past 20 years in China, limiting statistical power.
This study was limited to vaccine MAAs with publicly disclosed information, which may affect generalizability. Additionally, the CDE does not distinguish initial applications, indication expansions, and administration route changes or the multiple review cycles 1 application may experience, preventing separate evaluation of these categories.
The reference list from the paper itself. Each links out to its DOI / PubMed record.
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- 4Yaozhi Database. Accessed January 13, 2025. https://db.yaozh.com
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