Clinical efficacy and safety of medicines procured through China’s national volume-based procurement policy: a systematic review of 81 studies
- 1School of International Pharmaceutical Business, China Pharmaceutical University
Abstract
Background: China’s National Volume-Based Procurement (NVBP) policy, launched in 2018, has sharply cut drug prices through competitive bidding among manufacturers of quality-consistent generics. Concerns persist that reductions sometimes exceeding 90% may compromise efficacy or safety, and this evidence has not been systematically synthesised.
Objective: To evaluate the efficacy, safety and pharmacokinetics of NVBP-selected medicines.
Methods: Six sources (PubMed, Web of Science, Cochrane CENTRAL, CNKI, Wanfang Data, VIP) were searched in two arms for reports published between January 2018 and January 2026; CENTRAL records could not be exported. Titles and abstracts were screened by one reviewer with a second checking; all 862 full-text reports were screened in duplicate. Risk of bias was assessed in eight domains, three specific to this policy setting, and certainty with GRADE. Results were synthesised without meta-analysis by effect direction within comparator strata. PROSPERO: CRD420261303351.
Results: Eighty-one studies were included, 72 from the database searches and nine from citation searching; 72 were retrospective or before-and-after and 62 single-centre. Sixty-eight studies plus one comparison from a six-arm study formed the main analysis against the originator. There, 60 of 62 counted efficacy comparisons and 55 of 65 safety comparisons found no significant difference, and no efficacy comparison carries an assigned direction. Four safety comparisons favoured the originator (moxifloxacin tablets, olanzapine, paediatric ceftriaxone, atorvastatin) and three favoured the selected product (linezolid tablets, ceftriaxone, bortezomib); no direction could be assigned in three. Acquisition costs were 44% to more than 90% lower wherever reported. The median smallest detectable fall in response rate was 16.5 percentage points and the median smallest detectable relative risk for harm 2.67, reflecting the sample sizes available. Certainty was very low for efficacy, safety and pharmacokinetics, and low for economic outcomes.
Conclusion: The available evidence does not show that NVBP-selected generics perform worse than their comparators, but its certainty is very low and the concordance of null findings cannot be read as demonstrated equivalence. Most studies reported no effect estimate, many were small and single-centre, and six reported statistics irreconcilable with their own data. Prospective, adequately powered studies reporting estimates with confidence intervals remain necessary.
Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261303351 ; Identifier: CRD420261303351.
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BibTeX
@article{zhang2026clinical,
title = {{Clinical efficacy and safety of medicines procured through China’s national volume-based procurement policy: a systematic review of 81 studies}},
author = {Lele Zhang and Youjie Zhang},
journal = {Frontiers in Public Health},
year = {2026},
month = oct,
doi = {10.3389/fpubh.2026.1820505},
url = {https://www.frontiersin.org/articles/10.3389/fpubh.2026.1820505/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Clinical efficacy and safety of medicines procured through China’s national volume-based procurement policy: a systematic review of 81 studies
AU - Lele Zhang
AU - Youjie Zhang
PY - 2026
DA - 2026/10/15
JO - Frontiers in Public Health
DO - 10.3389/fpubh.2026.1820505
UR - https://www.frontiersin.org/articles/10.3389/fpubh.2026.1820505/full
AB - Background: China’s National Volume-Based Procurement (NVBP) policy, launched in 2018, has sharply cut drug prices through competitive bidding among manufacturers of quality-consistent generics. Concerns persist that reductions sometimes exceeding 90% may compromise efficacy or safety, and this evidence has not been systematically synthesised. Objective: To evaluate the efficacy, safety and pharmacokinetics of NVBP-selected medicines. Methods: Six sources (PubMed, Web of Science, Cochrane CENTRAL, CNKI, Wanfang Data, VIP) were searched in two arms for reports published between January 2018 and January 2026; CENTRAL records could not be exported. Titles and abstracts were screened by one reviewer with a second checking; all 862 full-text reports were screened in duplicate. Risk of bias was assessed in eight domains, three specific to this policy setting, and certainty with GRADE. Results were synthesised without meta-analysis by effect direction within comparator strata. PROSPERO: CRD420261303351. Results: Eighty-one studies were included, 72 from the database searches and nine from citation searching; 72 were retrospective or before-and-after and 62 single-centre. Sixty-eight studies plus one comparison from a six-arm study formed the main analysis against the originator. There, 60 of 62 counted efficacy comparisons and 55 of 65 safety comparisons found no significant difference, and no efficacy comparison carries an assigned direction. Four safety comparisons favoured the originator (moxifloxacin tablets, olanzapine, paediatric ceftriaxone, atorvastatin) and three favoured the selected product (linezolid tablets, ceftriaxone, bortezomib); no direction could be assigned in three. Acquisition costs were 44% to more than 90% lower wherever reported. The median smallest detectable fall in response rate was 16.5 percentage points and the median smallest detectable relative risk for harm 2.67, reflecting the sample sizes available. Certainty was very low for efficacy, safety and pharmacokinetics, and low for economic outcomes. Conclusion: The available evidence does not show that NVBP-selected generics perform worse than their comparators, but its certainty is very low and the concordance of null findings cannot be read as demonstrated equivalence. Most studies reported no effect estimate, many were small and single-centre, and six reported statistics irreconcilable with their own data. Prospective, adequately powered studies reporting estimates with confidence intervals remain necessary. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261303351 ; Identifier: CRD420261303351.
SN - 2296-2565
ER -